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Protocol of a clinical trial on the effectiveness of pudendal nerve block with and without neurostimulation in reducing posthemorroidectomy pain
Protocolo de un ensayo clínico sobre la efectividad del bloqueo del nervio pudendo con y sin neuroestimulación para la disminución del dolor posthemorroidectomía
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"apellidos" => "Balanzá" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "Departamento de Cirugía, Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Departamento de Cirugía, Complejo Hospitalario Universitario de Vigo, Vigo, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Departamento de Anestesiología y Reanimación, Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Protocolo de un ensayo clínico sobre la efectividad del bloqueo del nervio pudendo con y sin neuroestimulación para la disminución del dolor posthemorroidectomía" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall"><elsevierMultimedia ident="tb0005"></elsevierMultimedia></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Introduction</span><p id="par0030" class="elsevierStylePara elsevierViewall">Haemorrhoidal disease is the progressive transformation of normal structures into pathological ones due to mechanical, vascular and muscular factors. With a prevalence of 44% in the adult population, it is probably the most common anal pathology.</p><p id="par0035" class="elsevierStylePara elsevierViewall">Approximately 80% of cases are only treated medically.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Several options are available to patients that are refractory to medical treatment and to patients with grade 3 or 4 haemorrhoids, including outpatient treatment (elastic band ligation, sclerosis, infrared coagulation) and surgery (Milligan-Morgan/Ferguson haemorrhoidectomy, stapled haemorrhoidopexy, or Doppler-guided dearterialization with or without mucopexy).<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> Although surgery is the most effective treatment, moderate-to-severe pain experienced by 30%–40% of patients during the first 24−48 postoperative hours is the most feared complication.<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,4</span></a></p><p id="par0040" class="elsevierStylePara elsevierViewall">The ultimate goal of any regional block technique is to deposit sufficient volume and concentration of local anaesthetic as close as possible to the target nerve. Pudendal nerve block, a well-known, effective pain control strategy that has been used in urological, gynaecological, and proctological procedures, has been widely studied in the context of haemorrhoidal surgery.<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5,6</span></a></p><p id="par0045" class="elsevierStylePara elsevierViewall">The pudendal nerve presents important anatomical variations, and can present as a single trunk (53.3%), 2 trunks (36.7%), and 3 trunks (6.7%), so between 10% and 50% of pudendal blocks are ineffective on one or both sides when anatomical landmarks are used to guide anaesthesia infiltration. For this reason, clinicians have attempted to identify neurolocalization strategies that can boost the analgesia success rate. The use of a peripheral nerve stimulator, or neurostimulator, is an alternative to anatomical location of the nerve.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Pudendal nerve block guided by anatomical landmarks has proven useful in controlling post-haemorrhoidectomy pain, and although the use of neurostimulation-guided pudendal nerve block has not been widely studied, we believe it can improve outcomes in these patients.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7,8</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">The working hypothesis of this study is that patients receiving neurostimulation-guided pudendal nerve block after haemorrhoidectomy will report less postoperative pain than those receiving solely landmark-guided nerve block.</p><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Material and method</span><p id="par0060" class="elsevierStylePara elsevierViewall">The main objective of this study is to compare immediate post-haemorrhoidectomy (24 h) pain in patients receiving neurostimulation-guided vs landmark-guided pudendal nerve block.</p><p id="par0065" class="elsevierStylePara elsevierViewall">The secondary objectives were:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">•</span><p id="par0070" class="elsevierStylePara elsevierViewall">To compare post-haemorrhoidectomy pain during the first postoperative week in patients receiving neurostimulation-guided vs landmark-guided pudendal nerve block.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">•</span><p id="par0075" class="elsevierStylePara elsevierViewall">To determine the need for rescue pain medication in both groups.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">•</span><p id="par0080" class="elsevierStylePara elsevierViewall">To evaluate post-treatment patient satisfaction in both groups.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">•</span><p id="par0085" class="elsevierStylePara elsevierViewall">To compare complications in both groups.</p></li></ul></p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Study design</span><p id="par0090" class="elsevierStylePara elsevierViewall">This will be a single-site, triple-blind, randomized clinical efficacy trial carried out during usual clinical practice.</p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0080">Randomization</span><p id="par0095" class="elsevierStylePara elsevierViewall">Patients will be randomised to either the neurostimulation-guided group or the landmark-guided group using a sequence of random numbers generated by the Stata 13.0 statistical package.</p><p id="par0100" class="elsevierStylePara elsevierViewall">Sealed envelopes containing the randomly generated allocation group will be placed in our hospital's operating room and opened by members of the research team after surgery has finalised.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0085">Masking</span><p id="par0105" class="elsevierStylePara elsevierViewall">Study subjects, the observing investigator, and the study data analyst will be blinded to the treatment received.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0090">Study population</span><p id="par0110" class="elsevierStylePara elsevierViewall">We intend to extrapolate the results of this study to all patients with haemorrhoids refractory to medical treatment, symptomatic grade 3–4 haemorrhoids, and grade 2 haemorrhoids that do not respond to conservative measures (haemorrhoidal ligation/sclerosis) and who are eligible for major outpatient surgery (MOS). Therefore, the sample will be recruited on the basis of the following inclusion and exclusion criteria.</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0095">Inclusion criteria</span><p id="par0115" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">•</span><p id="par0120" class="elsevierStylePara elsevierViewall">Patients treated in a tertiary hospital in Spain for haemorrhoids refractory to medical treatment, symptomatic grade 3–4 haemorrhoids, and grade 2 haemorrhoids that do not respond to conservative measures (haemorrhoidal ligation/sclerosis).</p></li><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">•</span><p id="par0125" class="elsevierStylePara elsevierViewall">Scheduled for MOS in our hospital</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">•</span><p id="par0130" class="elsevierStylePara elsevierViewall">Need for a trained companion at the time of patient discharge</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">•</span><p id="par0135" class="elsevierStylePara elsevierViewall">Age <71 years</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">•</span><p id="par0140" class="elsevierStylePara elsevierViewall">ASA Class I and II</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">•</span><p id="par0145" class="elsevierStylePara elsevierViewall">BMI <30</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">•</span><p id="par0150" class="elsevierStylePara elsevierViewall">Patients with coagulopathies, heart disease, COPD with low exercise tolerance or decompensated COPD will be excluded.</p></li><li class="elsevierStyleListItem" id="lsti0060"><span class="elsevierStyleLabel">•</span><p id="par0155" class="elsevierStylePara elsevierViewall">Age >18 years</p></li><li class="elsevierStyleListItem" id="lsti0065"><span class="elsevierStyleLabel">•</span><p id="par0160" class="elsevierStylePara elsevierViewall">Willing to take part in the study and sign the informed consent form.</p></li></ul></p></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0100">Exclusion criteria</span><p id="par0165" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0015"><li class="elsevierStyleListItem" id="lsti0070"><span class="elsevierStyleLabel">•</span><p id="par0170" class="elsevierStylePara elsevierViewall">Patients diagnosed with inflammatory bowel disease</p></li><li class="elsevierStyleListItem" id="lsti0075"><span class="elsevierStyleLabel">•</span><p id="par0175" class="elsevierStylePara elsevierViewall">Concomitant anal pathology (fissure, fistula, etc.)</p></li><li class="elsevierStyleListItem" id="lsti0080"><span class="elsevierStyleLabel">•</span><p id="par0180" class="elsevierStylePara elsevierViewall">Haemorrhoidal disease with surgical indication other than the Ferguson technique</p></li><li class="elsevierStyleListItem" id="lsti0085"><span class="elsevierStyleLabel">•</span><p id="par0185" class="elsevierStylePara elsevierViewall">Chronic pain in treatment with opioids or opioid derivatives</p></li><li class="elsevierStyleListItem" id="lsti0090"><span class="elsevierStyleLabel">•</span><p id="par0190" class="elsevierStylePara elsevierViewall">Paracetamol and NSAIDs allergy</p></li></ul></p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0105">Sample size calculation</span><p id="par0195" class="elsevierStylePara elsevierViewall">Calculated on Epidat 4.2 to detect a difference of 1 point on the verbal numerical pain scale (standard deviation 1.5), significance level of p < 0.05, and assuming a statistical power of 80%, the number of patients to be treated would be 74 (37 in each group). Assuming 15% losses, we will need to recruit 86 patients.</p><p id="par0200" class="elsevierStylePara elsevierViewall">An interim analysis will be performed when we have recruited patient number 80. If the results obtained show that the study lacks sufficient statistical power and we believe that the objectives can be achieved by increasing the sample size, recruitment will be extended to a maximum of 150 patients.</p><p id="par0205" class="elsevierStylePara elsevierViewall">Based on the number of haemorrhoidectomies performed in our hospital’s MOS unit in previous years (we perform between 50 and 70 haemorrhoidectomies per year), we estimate that the study will last approximately 18 months.</p></span></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0110">Study plan</span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0115">Selection period</span><p id="par0210" class="elsevierStylePara elsevierViewall">The study will be performed in the Colorectal Surgery Unit of the General and Gastrointestinal Surgery Service of Hospital XX. Patients with suspected haemorrhoidal pathology will be evaluated in the general and gastrointestinal surgery consulting room as per usual practice, and those with an indication for haemorrhoidectomy according to the usual criteria will be placed on the surgery waiting list after evaluating symptoms, conducting a physical examination, evaluating response to conservative treatment, and ordering complementary tests if necessary, as per standard practice. Patients over 40 years of age with a history of bleeding will undergo a colonoscopy, as recommended by the American College of Surgeons.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p><p id="par0215" class="elsevierStylePara elsevierViewall">Patients on the waiting list will be seen again prior to the intervention. This visit will be carried out by the principle investigator, who will assess whether the patient fulfils all the inclusion and none of the exclusion criteria, give the patient information about the study and invite them to participate. All patients that accept the invitation will sign the informed consent form, and following this a standardized clinical history will be taken that includes demographic variables, personal history, and details of the haemorrhoidal pathology. The patient will be asked to complete 2 quality of life questionnaires (the Short Health Scale adapted for haemorrhoidal disease [SHSHD] and the SF-36 questionnaire) and will undergoing a pre-anaesthesia evaluation for MOS before receiving a definitive date for surgery.</p><p id="par0220" class="elsevierStylePara elsevierViewall">Patient enrolment started in 2022, and we expect to finalise recruitment and publish the results by the end of 2023.</p></span><span id="sec0060" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0120">Perioperative and intraoperative</span><p id="par0225" class="elsevierStylePara elsevierViewall">In the anaesthetic room, all patients with no allergic history will be given the following:<ul class="elsevierStyleList" id="lis0020"><li class="elsevierStyleListItem" id="lsti0095"><span class="elsevierStyleLabel">•</span><p id="par0230" class="elsevierStylePara elsevierViewall">Paracetamol 1 g iv.</p></li><li class="elsevierStyleListItem" id="lsti0100"><span class="elsevierStyleLabel">•</span><p id="par0235" class="elsevierStylePara elsevierViewall">Dexketoprofen 25 mg iv.</p></li><li class="elsevierStyleListItem" id="lsti0105"><span class="elsevierStyleLabel">•</span><p id="par0240" class="elsevierStylePara elsevierViewall">Ondansetron 8 mg.</p></li><li class="elsevierStyleListItem" id="lsti0110"><span class="elsevierStyleLabel">•</span><p id="par0245" class="elsevierStylePara elsevierViewall">Metoclopramide 10 mg.</p></li><li class="elsevierStyleListItem" id="lsti0115"><span class="elsevierStyleLabel">•</span><p id="par0250" class="elsevierStylePara elsevierViewall">Methylprednisolone 0.5 mg/kg.</p></li><li class="elsevierStyleListItem" id="lsti0120"><span class="elsevierStyleLabel">•</span><p id="par0255" class="elsevierStylePara elsevierViewall">Amoxicillin 2 g iv.</p></li></ul></p><p id="par0260" class="elsevierStylePara elsevierViewall">Surgery will be performed under general anaesthesia with orotracheal intubation or a laryngeal mask airway, at the discretion of the anaesthesiologist. Anaesthesia will be induced with remifentanil and propofol (in both cases, the dose sill be titrated using target controlled infusion), and rocuronium will be administered for neuromuscular blockade.</p><p id="par0265" class="elsevierStylePara elsevierViewall">Surgery will be performed in the prone or supine position, as indicated by the treating surgeon, following the Ferguson technique.</p><p id="par0270" class="elsevierStylePara elsevierViewall">The intervention will be performed by a colorectal surgeon belonging to the research team. After surgery has finalised, the corresponding envelope with the randomised group allocation will be opened.</p><p id="par0275" class="elsevierStylePara elsevierViewall">To prevent experience in neurostimulation-guided infiltration from influencing the performance of landmark-guided infiltration, 2 groups of surgeons will be created (1 surgeon from each group will be present during each intervention): 1 group will perform landmark-guided infiltration and the other will perform neurostimulation-guided infiltration. The surgeons performing neurostimulation-guided infiltration have learned the technique from anaesthesiologists from our unit specializing in regional blocks, and will have performed 20 neurostimulation-guided nerve blocks before starting the study. In both cases, pudendal nerve block will be performed at the end of surgery, injecting 10 ml of 0.5 bupivacaine without a vasoconstrictor on each side.</p></span><span id="sec0065" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0125">Landmark-guided block</span><p id="par0280" class="elsevierStylePara elsevierViewall">The key to the technique is to locate the ischial tuberosity using the hand that will not be used to perform the injection. It is sometimes useful to perform a digital rectal examination to guide the needle towards the ischial tuberosity. Once located, 5 mL of anaesthetic solution is deposited around the inferior anterior aspect of the ischial tuberosity and the other 5 mL is deposited as the needle is withdrawn</p></span><span id="sec0070" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0130">Neurostimulation-guided infiltration</span><p id="par0285" class="elsevierStylePara elsevierViewall">Neurostimulation will not begin until the neuromuscular blockade has been reversed with sugamadex, titrating the dose according to the depth of the TOF neuromuscular blockade. TOF stimulation is used to assess the depth of blockade. Four stimuli are delivered with a frequency of 2 Hz (2 per second). The amplitude of the fourth response in relation to the first gives the train-of-four ratio (T4:T1 ratio) and shows the degree of blockade. The four TOF responses disappear in reverse order to the depth of blockade. The fourth TOF response disappears when 75%–80% of the receptors are occupied, the third response disappears at 85% occupancy, the second response disappears at 85 %–90 % occupancy, and the first response disappears at 90%–95% occupancy. We will start stimulation when we have 4 T1–T4 responses (4 visible twitches in the adductor pollicis).</p><p id="par0290" class="elsevierStylePara elsevierViewall">Once neuromuscular blockade has been reversed, we will start the neurostimulator, setting the frequency to 2 Hz, and then connect the alligator clip cable to the skin electrode, and the needle to the cable connector. The output current averages 1.0 mA. Then the needle is inserted at the puncture site and advanced towards the lower rectal branch of the pudendal nerve, for which we have to achieve an anal muscle contraction. Once muscle contraction is achieved, we lower the output current to below 0.5 mA and above 0.2 mA to avoid intraneural infiltration. Once this has been achieved, we inject 10 mL of bupivacaine without moving the needle. Nerve block is positive if no muscle contractions are observed. The procedure is repeated on the contralateral side.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a></p><p id="par0295" class="elsevierStylePara elsevierViewall">If the patient reports pain in the immediate postoperative period, 400 mg intravenous ibuprofen will be administered.</p><p id="par0300" class="elsevierStylePara elsevierViewall">Although few pudendal nerve block-related complications have been reported, the following may appear: vascular injury, intravascular local anaesthetic injection, muscle pain, urinary or faecal incontinence, haematoma or abscess at the injection site, and numbness in the area of the pudendal nerve.</p><p id="par0305" class="elsevierStylePara elsevierViewall">Post-anaesthesia recovery will be assessed using a system based on the Aldrete score to evaluate general status, pain, fever, therapeutic compliance, bleeding, oral tolerance, and limb colour, obtaining a score ranging from -8 to 8. Patients with a score between 4 and 8 are considered suitable for discharge from the unit.</p></span></span><span id="sec0075" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0135">Treatment after discharge</span><p id="par0310" class="elsevierStylePara elsevierViewall">Sitz bath with warm water after each bowel movement. No use of toilet paper.</p><span id="sec0080" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0140">Normal fibre-rich diet</span><p id="par0315" class="elsevierStylePara elsevierViewall">Liquid paraffin 478.26 mg/mL in oral emulsion: 15 ml or a large spoonful 2 times a day taken in the morning 2 h before or after breakfast and another before bedtime. No more than 30 ml or 2 large spoonfuls per day.</p><p id="par0320" class="elsevierStylePara elsevierViewall">Metronidazole 250 mg: 2 tablets p.o. every 8 h for 5 days</p></span><span id="sec0085" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0145">Level 3 analgesia</span><p id="par0325" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="lis0025"><li class="elsevierStyleListItem" id="lsti0125"><span class="elsevierStyleLabel">•</span><p id="par0330" class="elsevierStylePara elsevierViewall">PARACETAMOL 1 g: 1 tablet p.o. every 6 h for 7 days.</p></li><li class="elsevierStyleListItem" id="lsti0130"><span class="elsevierStyleLabel">•</span><p id="par0335" class="elsevierStylePara elsevierViewall">DEXKETOPROFEN 25 mg: 1 sachet every 8 h for 3 days.</p></li><li class="elsevierStyleListItem" id="lsti0135"><span class="elsevierStyleLabel">•</span><p id="par0340" class="elsevierStylePara elsevierViewall">OMEPRAZOL 40 mg: 1 tablet p.o. every 24 h for 7 days.</p></li><li class="elsevierStyleListItem" id="lsti0140"><span class="elsevierStyleLabel">•</span><p id="par0345" class="elsevierStylePara elsevierViewall">IF PAIN PERSISTS: METAMIZOL 575 mg: 2 capsules every 12 h for 5 days.</p></li><li class="elsevierStyleListItem" id="lsti0145"><span class="elsevierStyleLabel">-</span><p id="par0350" class="elsevierStylePara elsevierViewall">Delivery of the patient diary (symptoms, bowel movements, rescue medication) (ANNEX 4).</p></li></ul></p></span><span id="sec0090" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0150">Follow up</span><p id="par0355" class="elsevierStylePara elsevierViewall">In the immediate postoperative period patients will be asked to rate their pain on the verbal numerical pain scale.</p><p id="par0360" class="elsevierStylePara elsevierViewall">They will be followed up again 24 h after discharge and on the 7th postoperative day by a person unrelated to the intervention (surgeon included in the study who has not participated in the interventions) who is unaware of the nerve block technique used.</p><p id="par0365" class="elsevierStylePara elsevierViewall">Patients will attend an in-person consultation with the principle investigator 1 month after the intervention.</p></span></span><span id="sec0095" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0155">Study variables</span><p id="par0370" class="elsevierStylePara elsevierViewall">(see annexes 1–5)<ul class="elsevierStyleList" id="lis0030"><li class="elsevierStyleListItem" id="lsti0150"><span class="elsevierStyleLabel">•</span><p id="par0375" class="elsevierStylePara elsevierViewall">Demographic variables and personal history.</p></li><li class="elsevierStyleListItem" id="lsti0155"><span class="elsevierStyleLabel">•</span><p id="par0380" class="elsevierStylePara elsevierViewall">Symptoms (bleeding, pain, prolapse, soiling, itching).</p></li><li class="elsevierStyleListItem" id="lsti0160"><span class="elsevierStyleLabel">•</span><p id="par0385" class="elsevierStylePara elsevierViewall">Verbal numerical rating scale: preoperatively, 1 h post-surgery, 24 h post-surgery, 7 days post-surgery and 1 month post-surgery in both groups.</p></li><li class="elsevierStyleListItem" id="lsti0165"><span class="elsevierStyleLabel">•</span><p id="par0390" class="elsevierStylePara elsevierViewall">Constipation, preoperative and postoperative.</p></li><li class="elsevierStyleListItem" id="lsti0170"><span class="elsevierStyleLabel">•</span><p id="par0395" class="elsevierStylePara elsevierViewall">Need for laxatives.</p></li><li class="elsevierStyleListItem" id="lsti0175"><span class="elsevierStyleLabel">•</span><p id="par0400" class="elsevierStylePara elsevierViewall">Short Health Scale adapted for haemorrhoidal disease (SHSHD).</p></li><li class="elsevierStyleListItem" id="lsti0180"><span class="elsevierStyleLabel">•</span><p id="par0405" class="elsevierStylePara elsevierViewall">Preoperative SF-36 questionnaire.</p></li><li class="elsevierStyleListItem" id="lsti0185"><span class="elsevierStyleLabel">•</span><p id="par0410" class="elsevierStylePara elsevierViewall">Nerve block technique.</p></li><li class="elsevierStyleListItem" id="lsti0190"><span class="elsevierStyleLabel">•</span><p id="par0415" class="elsevierStylePara elsevierViewall">Surgical position.</p></li><li class="elsevierStyleListItem" id="lsti0195"><span class="elsevierStyleLabel">•</span><p id="par0420" class="elsevierStylePara elsevierViewall">Number and location of haemorrhoidal bundles removed.</p></li><li class="elsevierStyleListItem" id="lsti0200"><span class="elsevierStyleLabel">•</span><p id="par0425" class="elsevierStylePara elsevierViewall">Need for rescue analgesia.</p></li></ul></p></span><span id="sec0100" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0160">Statistical analysis of study results</span><p id="par0430" class="elsevierStylePara elsevierViewall">All the data needed for the study will be collected in the data collection sheet. Patients will not be identified by their personal details - only by a numerical code corresponding to their order of inclusion in the study. The data will be uploaded to a Stata 13.0 database by the principle investigator.</p><p id="par0435" class="elsevierStylePara elsevierViewall">The primary analysis, according to the main objective of the study, will compare immediate postoperative pain (24 h) between groups. This comparison will be performed with the Student’s t test. In the event of inter-group differences in potentially confounding variables (age, etc.), a multivariate linear regression analysis will be performed.</p><p id="par0440" class="elsevierStylePara elsevierViewall">The secondary objectives will be analysed using tests corresponding to the type of variable. Qualitative variables will be analysed using the 95% confidence interval of the percentage difference, and an appropriate hypothesis test will be performed (Chi square or Fisher, depending on the number of subjects in each group). The normality of quantitative variables will be verified with the Kolmogorov-Smirnov Test, if necessary, and they will be analysed using the 95% confidence interval of the difference between means and the corresponding hypothesis test (Student's t, ANOVA, or Mann–Whitney U).</p><p id="par0445" class="elsevierStylePara elsevierViewall">The statistical analysis will be performed on Stata 13.0. The level of significance is established at p < 0.05.</p><span id="sec0105" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0165">Ethics</span><p id="par0450" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest and that this study has not received any funding. All procedures will be performed in accordance with the ethical requirements of our institution, of the research ethics committee, and the 1964 Helsinki declaration and subsequent modifications.</p><p id="par0455" class="elsevierStylePara elsevierViewall">All patients enrolled will sign a specific informed consent before inclusion in the study.</p><p id="par0460" class="elsevierStylePara elsevierViewall">This protocol was approved by the research ethics committee CHUNSC_2022_64 and has been registered in ISRCTN under number ISRCTN22877737.</p></span></span><span id="sec0110" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0170">Results</span><p id="par0465" class="elsevierStylePara elsevierViewall">Not available until the end of the trial.</p></span><span id="sec0115" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0175">Discussion</span><p id="par0470" class="elsevierStylePara elsevierViewall">Pudendal nerve block after colorectal surgery has been shown to reduce postoperative pain, hospital stay, and opioid consumption, and to promote early return to activities of daily living.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> For this reason, the PROSPECT (PROcedure-SPECific post-operative pain management) task force issued a grade A recommendation to administer oral analgesics, oral diosmin, metronidazole, laxatives, topical lidocaine, and nerve block with long-acting anaesthetics for postoperative pain management.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Pudendal nerve block has been shown to prolong pain control compared to perianal anaesthesia alone, and also provides more effective pain control and fewer complications when administered after general anaesthesia compared to spinal anaesthesia.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a></p><p id="par0475" class="elsevierStylePara elsevierViewall">In their anatomical description of the pudendal nerve, Grabielli and Olave found that it can present as a single trunk (53.3%), as 2 trunks (36.7%), and as 3 trunks (6.7%).<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Mahakkanukrauh et al. also found pudendal nerves with 1 trunk (56.2%), 2 trunks (31.5%), and 3 trunks (12.3%),<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> and Furtmuller et al., in an anatomical study, found that in most cases the perineal branch and the rectal branch arise from a common trunk.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a></p><p id="par0480" class="elsevierStylePara elsevierViewall">This anatomical variability can render landmark-guided nerve block ineffective; therefore, accurately locating the nerve using neurostimulation could ensure that the local anaesthetic is deposited correctly and achieves effective nerve block. However, there are as yet no studies adequately comparing neurostimulation-guided and landmark-guided pudendal nerve block in patients undergoing haemorrhoidal resection surgery. We hope that this clinical trial will clarify whether neurostimulation-guided blockade is really more effective.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:12 [ 0 => array:3 [ "identificador" => "xres2260298" "titulo" => "Abstract" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] 1 => array:2 [ "identificador" => "xpalclavsec1885926" "titulo" => "Keywords" ] 2 => array:3 [ "identificador" => "xres2260297" "titulo" => "Resumen" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] 3 => array:2 [ "identificador" => "xpalclavsec1885927" "titulo" => "Palabras clave" ] 4 => array:3 [ "identificador" => "sec0005" "titulo" => "Introduction" "secciones" => array:8 [ 0 => array:2 [ "identificador" => "sec0010" "titulo" => "Material and method" ] 1 => array:2 [ "identificador" => "sec0015" "titulo" => "Study design" ] 2 => array:2 [ "identificador" => "sec0020" "titulo" => "Randomization" ] 3 => array:2 [ "identificador" => "sec0025" "titulo" => "Masking" ] 4 => array:2 [ "identificador" => "sec0030" "titulo" => "Study population" ] 5 => array:2 [ "identificador" => "sec0035" "titulo" => "Inclusion criteria" ] 6 => array:2 [ "identificador" => "sec0040" "titulo" => "Exclusion criteria" ] 7 => array:2 [ "identificador" => "sec0045" "titulo" => "Sample size calculation" ] ] ] 5 => array:3 [ "identificador" => "sec0050" "titulo" => "Study plan" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0055" "titulo" => "Selection period" ] 1 => array:2 [ "identificador" => "sec0060" "titulo" => "Perioperative and intraoperative" ] 2 => array:2 [ "identificador" => "sec0065" "titulo" => "Landmark-guided block" ] 3 => array:2 [ "identificador" => "sec0070" "titulo" => "Neurostimulation-guided infiltration" ] ] ] 6 => array:3 [ "identificador" => "sec0075" "titulo" => "Treatment after discharge" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0080" "titulo" => "Normal fibre-rich diet" ] 1 => array:2 [ "identificador" => "sec0085" "titulo" => "Level 3 analgesia" ] 2 => array:2 [ "identificador" => "sec0090" "titulo" => "Follow up" ] ] ] 7 => array:2 [ "identificador" => "sec0095" "titulo" => "Study variables" ] 8 => array:3 [ "identificador" => "sec0100" "titulo" => "Statistical analysis of study results" "secciones" => array:1 [ 0 => array:2 [ "identificador" => "sec0105" "titulo" => "Ethics" ] ] ] 9 => array:2 [ "identificador" => "sec0110" "titulo" => "Results" ] 10 => array:2 [ "identificador" => "sec0115" "titulo" => "Discussion" ] 11 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2023-05-24" "fechaAceptado" => "2023-11-19" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1885926" "palabras" => array:4 [ 0 => "Hemorrhoidectomy" 1 => "Posthemorrhoidectomy pain" 2 => "Neurostimulation" 3 => "Pudendal nerve block" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec1885927" "palabras" => array:4 [ 0 => "Hemorroidectomía" 1 => "Dolor posthemorroidectomía" 2 => "Neuroestimulación" 3 => "Bloqueo nervio pudendo" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:3 [ "titulo" => "Abstract" "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Introduction</span><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Hemorrhoidal pathology is the most frequent proctological problem with a prevalence of 44% of the adult population. The most effective treatment is surgery but it also has the highest postoperative pain rate with moderate to severe pain rates of 30–40% during the first 24−48 hours. Here lies the importance of seeking measures to improve this situation, such as the pudendal nerve block with local anesthetic. However, the variability of the pudendal nerve sometimes makes its blockade ineffective and for this reason nerve location methods are sought to achieve a higher rate of success. The main aim of the study is to compare pain in the immediate postoperative period (24 h) after hemorrhoidectomy in patients with pudendal nerve block guided by anatomical references and guided by neurostimulation.</p></span> <span id="abst0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Methods</span><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">The present project proposes the performance of a single-center, triple-blind, randomized clinical trial of efficacy, carried out under conditions of routine clinical practice. Patients over 18 years old with hemorrhoids refractory to medical treatment, symptomatic grade III-IV and grade II hemorrhoids that do not respond to conservative procedures in a third level hospital in Spain and that are subsidiaries of surgery in major ambulatory surgery will be included. Demographic variables, variables on hemorrhoidal pathology, details of surgery, verbal numeric pain scale in the preoperative period and surgical complications will be collected.</p></span> <span id="abst0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Results</span><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Not avaliable until the end of the study.</p></span> <span id="abst0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Conclusions</span><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">The pudendal nerve block guided by anatomical landmarks has been shown to be useful in postoperative pain control after hemorrhoidectomy although the use of the neurostimulator has not been well studied and we believe it may improve outcom</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "abst0010" "titulo" => "Methods" ] 2 => array:2 [ "identificador" => "abst0015" "titulo" => "Results" ] 3 => array:2 [ "identificador" => "abst0020" "titulo" => "Conclusions" ] ] ] "es" => array:3 [ "titulo" => "Resumen" "resumen" => "<span id="abst0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Introducción</span><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La patología hemorroidal es el problema proctológico más frecuente con una prevalencia de 44% de la población adulta. El tratamiento más eficaz es la cirugía, pero también es la que presenta mayor tasa de dolor postoperatorio con unas tasas de dolor moderado a severo de 30–40 % durante las primeras 24−48 h. Aquí radica la importancia de buscar medidas que mejoren esta situación, como es el bloqueo del nervio pudendo con anestésico local. Sin embargo, la variabilidad del nervio pudendo hace que a veces su bloqueo sea inefectivo y por ello se buscan formas de neurolocalización para conseguir mayor tasa de éxito. El objetivo principal del estudio es comparar el dolor en el postoperatorio inmediato (24 h) tras hemorroidectomía en pacientes con bloqueo del nervio pudendo guiado por referencias anatómicas y guiado por neuroestimulación.</p></span> <span id="abst0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Métodos</span><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">El presente proyecto propone la realización de un ensayo clínico aleatorizado unicéntrico, triple ciego, de eficacia, realizado en condiciones de práctica clínica habitual. Se incluirán pacientes mayores de 18 años con hemorroides refractarias a tratamiento médico, grado III-IV sintomáticas y hemorroides grado II que no responden a procedimientos conservadores en un hospital de tercer nivel en España y que sean subsidiarios de cirugía en cirugía mayor ambulatoria. Se recogerán variables variables demográficas, variables sobre la patología hemorroidal, detalles de la cirugía, escala verbal numérica del dolor en el preoperatorio y las complicaciones quirúrgicas.</p></span> <span id="abst0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Resultados</span><p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">No disponibles hasta finalizar el ensayo.</p></span> <span id="abst0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Conclusiones</span><p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">El bloqueo del nervio pudendo guiado por referencias anatómicas ha demostrado ser útil en el control del dolor postoperatorio tras hemorroidectomía si bien el uso del neuroestimulador no ha sido bien estudiado y creemos que puede mejorar los resultados</p></span>" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "abst0025" "titulo" => "Introducción" ] 1 => array:2 [ "identificador" => "abst0030" "titulo" => "Métodos" ] 2 => array:2 [ "identificador" => "abst0035" "titulo" => "Resultados" ] 3 => array:2 [ "identificador" => "abst0040" "titulo" => "Conclusiones" ] ] ] ] "apendice" => array:1 [ 0 => array:1 [ "seccion" => array:1 [ 0 => array:4 [ "apendice" => "<p id="par0490" class="elsevierStylePara elsevierViewall">The following is Supplementary data to this article:<elsevierMultimedia ident="upi0005"></elsevierMultimedia></p>" "etiqueta" => "Appendix A" "titulo" => "Supplementary data" "identificador" => "sec0125" ] ] ] ] "multimedia" => array:2 [ 0 => array:5 [ "identificador" => "upi0005" "tipo" => "MULTIMEDIAECOMPONENTE" "mostrarFloat" => false "mostrarDisplay" => true "Ecomponente" => array:2 [ "fichero" => "mmc1.docx" "ficheroTamanyo" => 522809 ] ] 1 => array:5 [ "identificador" => "tb0005" "tipo" => "MULTIMEDIATEXTO" "mostrarFloat" => false "mostrarDisplay" => true "texto" => array:1 [ "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec9005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect5065">Key points</span><p id="par0010" class="elsevierStylePara elsevierViewall">Although surgery is the most effective treatment for haemorrhoid pathology, it is also associated with a high rate of postoperative pain.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Pudendal nerve block guided by anatomical landmarks has proven effective in controlling post-haemorrhoidectomy pain.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Due to the considerable anatomical variations of this nerve, using anatomical landmarks to guide local anaesthetic infiltration can sometimes be ineffective.</p><p id="par0025" class="elsevierStylePara elsevierViewall">The use of neurostimulation has not been widely studied, but we believe it can improve the results of the standard technique.</p></span></span>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:13 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Effect of acupuncture on post-hemorrhoidectomy pain: a randomized controlled trial" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:6 [ 0 => "J. 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