[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655387":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":64,"studyPopulation":52,"armGroups":65,"interventions":78,"overallOfficials":52,"centralContacts":88,"locations":52,"responsibleParty":98,"collaborators":52,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":102,"sex":108,"minAge":109,"maxAge":52,"enrollmentInfo":110,"targetDuration":52,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":127,"whyStopped":52,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":52},{"fullName":5,"class":6},"Vinmec Healthcare System","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Cumulative post operative opioid consumption at 48 Hours (MME)","Cumulative opioid consumption from the end of surgery through 48 hours after surgery, expressed as morphine milligram equivalents (MME). All postoperative opioid analgesics administered during the observation period will be converted to MME using the prespecified opioid conversion table.","Post operative From the end of surgery to 48 hours after surgery",[14,18,22,26,30,34,37,41,44,48],{"measure":15,"description":16,"timeFrame":17},"post operative pain intensity at rest","Pain intensity at rest measured by Visual Analogic Scale (VAS) ruller.","post operative at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after end of surgery",{"measure":19,"description":20,"timeFrame":21},"Post operative pain intensity during defecation","Pain Intensity during defecation using Visual Analogic Scale (VAS) ruler","at the first post operative defecation and during the first 48 hours post operative observation period.",{"measure":23,"description":24,"timeFrame":25},"Pain Intensity-time area under the curve over 48 hours after the end of surgery","Area under the curve of post operative VAS pain scores from end of the surgery through 48 hours.","from end of the surgery to 48 hours after surgery",{"measure":27,"description":28,"timeFrame":29},"cumulative post operative opioid consumption at 12 hours, 24 hours and 36 Hours","cumulative post operative opioid consumption at 12 hours, 24 hours and 36 Hours expressed as morphine miligram equivalents (MME)","Post operative : at 12 hours, 24 hours and 36 Hours after the surgery",{"measure":31,"description":32,"timeFrame":33},"Time to first rescue opioid administration","Time from end of surgery to the first rescue opioid administration","Post operative : from end of surgery through 48 hours after surgery",{"measure":35,"description":35,"timeFrame":36},"Proportion of participants who remain opioid free at 48 hours","post operative : From end of surgery through 48 hours after surgery",{"measure":38,"description":39,"timeFrame":40},"Quatilty of recovery assessed using the score QoR-15","Post operative Quatilty of recovery assessed using the score QoR-15","Post operative : 24 hours and 48 hours after the end of surgery",{"measure":42,"description":43,"timeFrame":33},"Adverse events (Nausea Vomiting Urinary retention)","Adverse events (Nausea Vomiting Urinary retention) from end of surgery through 48 hours after surgery",{"measure":45,"description":46,"timeFrame":47},"Block related complications","Occurence of complications related to pudendal nerve block","From block performance through 48 hours after surgery",{"measure":49,"description":50,"timeFrame":51},"Length of hospital stay after surgery performed","Length of hospital stay from end of surgery to hospital discharge","duration of post operative hospitalization : From end of surgery to hospital discharge up to one week",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":52,"timePerspective":52,"maskingInfo":58},"RANDOMIZED","PARALLEL","Prospective, randomised, controlled, parallel groups, superiority trial with a 1:1 allocation ratio","SUPPORTIVE_CARE",{"masking":59,"maskingDescription":60,"whoMasked":61},"DOUBLE","Participants and outcome assessors will be blinded to treatment allocation. Data analysts will also be blinded to treatment allocation. The anesthesiologist performing the pudendal nerve block cannot be blinded because the two interventions require different anatomical approaches.",[62,63],"PARTICIPANT","OUTCOMES_ASSESSOR","Context, rationale and hypothesis: Hemorrhoidectomy remains one of the most painful ambulatory surgical procedures, frequently associated with substantial postoperative opioid consumption despite multimodal analgesia. This persistent nociceptive burden has direct implications for delayed recovery, unplanned admissions, and opioid-related adverse events. Consequently, optimizing regional analgesic strategies is a priority within enhanced recovery pathways.\n\nPudendal nerve block (PNB), targeting sacral roots S2-S4, has emerged as an effective adjunct for postoperative analgesia in anorectal surgery. Randomized trials and meta-analyses consistently demonstrate reductions in pain scores and opioid requirements when PNB is incorporated into perioperative care. However, these studies encompass heterogeneous techniques, and critically, do not address whether the anatomical level of blockade influences clinical efficacy.\n\nFrom a mechanistic perspective, the pudendal nerve divides into its terminal branches-the inferior rectal, perineal, and dorsal genital nerves-after traversing the region of the ischial spine and entering Alcock's canal. The inferior rectal nerve, which provides the principal sensory innervation to the anal canal and perianal region, typically branches proximally before the pudendal nerve courses distally within the pudendal canal. This anatomical arrangement suggests that distal approaches to PNB, such as the transperineal technique, may incompletely anesthetize the inferior rectal nerve due to injection beyond the point of branching or variable spread within the ischiorectal fossa.\n\nIn contrast, the posterior transgluteal approach targets the pudendal nerve at a more proximal location, near the ischial spine and sacrospinous ligament, where the nerve remains a single trunk. Ultrasound guidance at this level enables precise deposition of local anesthetic before division into terminal branches, theoretically ensuring a more consistent and comprehensive blockade, including the inferior rectal nerve. This distinction in injection level-proximal versus distal-represents a fundamental but underexplored determinant of block success.\n\nDespite increasing adoption of ultrasound-guided regional anesthesia, there is a striking absence of randomized controlled trials directly comparing proximal (transgluteal) and distal (transperineal) approaches to PNB in the context of hemorrhoidectomy. Existing evidence is therefore insufficient to determine whether improved anatomical coverage translates into superior clinical analgesia or reduced opioid consumption.\n\nAddressing this gap is clinically relevant for several reasons. First, inadequate blockade of the inferior rectal nerve may contribute to residual pain during defecation, a key determinant of patient dissatisfaction after hemorrhoidectomy. Second, identifying a more reliable and reproducible technique could standardize PNB within perioperative protocols. Third, demonstrating superiority of a proximal approach would support broader integration of ultrasound-guided regional techniques into opioid-sparing strategies.\n\nThe present trial is designed to test the hypothesis that a proximal, ultrasound-guided transgluteal PNB provides superior postoperative analgesia compared with a distal transperineal approach. By directly comparing these techniques in a randomized controlled setting, this study seeks to determine whether anatomical optimization of nerve blockade translates into meaningful clinical benefit.\n\nOriginality and innovative aspects: Hemorrhoidectomy remains associated with significant postoperative pain, often requiring substantial opioid consumption. Pudendal nerve block (PNB), targeting nerve roots from S2-S4, has demonstrated efficacy in reducing postoperative pain and opioid requirements. Anatomically, the pudendal nerve gives rise to the inferior rectal, perineal, and dorsal genital nerves. The effectiveness of PNB depends on the level of injection:\n\n* Transgluteal (proximal) approach: blockade at the level of the ischial spine before nerve branching\n* Transperineal (distal) approach: injection within or near Alcock's canal after branching The distal approach may spare the inferior rectal nerve, leading to suboptimal anorectal analgesia. In contrast, the proximal ultrasound-guided technique may provide a more complete and reliable block.\n\nTo date, no randomized controlled trial has directly compared proximal (transgluteal) and distal (transperineal) approaches to pudendal nerve block in hemorrhoidectomy, despite clear anatomical rationale suggesting differences in nerve coverage and analgesic efficacy.\n\nMethods This study is a prospective, Randomized, Controlled, Parallel-group , Superiority trial, Assessor-blinded The protocol follows SPIRIT recommendations, and reporting will adhere to CONSORT guidelines Setting The study will be conducted at VinMec International Hospital, Can THo, Vietnam. Interventions Control Group (Standard Management): Trans perineal Group (Distal PNB) Spinal anesthesia protocol standardized; Ultrasound-guided transperineal approach ; Injection in rectoperineal\u002Fischiorectal fossa; Bilateral; Ropivacaine 0. 5%, 8 mL per side; Oral Paracetamol 500 mg every 6 hours; Oral Celecoxib 200 mg every 12 hours ( if no contra-indication); Rescue opioids if NRS pain values \\>3\u002F10 converted to MME Intervention Group: Transgluteal Group (Proximal PNB) General anesthesia protocol standardized; Ultrasound-guided posterior approach; Injection near ischial spine\u002Fsacrospinous ligament; Bilateral; Ropivacaine 0. 5%, 6 mL per side; Oral Paracetamol 500 mg every 6 hours; Oral Celecoxib 200 mg every 12 hours (if no contra-indication); Rescue opioids if NRS pain values \\>3\u002F10 converted to MME\n\nThe Block Techniques:\n\nTransperineal Approach Patient Positioning The patient is placed in the lithotomy position with slight hip abduction. Adequate exposure of the perineum is ensured under strict aseptic conditions.\n\nUltrasound Equipment and Probe Position A high-frequency linear transducer (10-18 MHz) is used. The probe is placed: Transversely or slightly oblique; On the perineum, lateral to the external anal sphincter; Over the ischio-rectal fossa.\n\nSonoanatomy Key structures to identify include: External anal sphincter (medial landmark); Ischioanal (ischiorectal) fossa (hypoechoic fat-filled space); Obturator internus muscle (lateral boundary); Internal pudendal artery (identified using color Doppler). The pudendal nerve is often not directly visualized, but lies medial to the internal pudendal artery and within or near Alcock's (pudendal) canal Needle Insertion Approach: in-plane, typically medial to lateral; Needle: 50mm echogenic needle advanced to the ischioanal fossa, adjacent to the internal pudendal artery.\n\nInjection 8 mL of local anesthetic is injected per side. The spread should be observed within the ischioanal fossa Controlled by Color echo Doppler to prevent IV injection.\n\nTransgluteal Approach Patient Positioning The patient is placed in the prone position (or lateral decubitus if needed). The gluteal region is exposed and prepared under sterile conditions.\n\nUltrasound Equipment and Probe Position A low-frequency curvilinear probe (2-5 MHz) or a high-frequency probe in lean patients may be used.\n\nThe probe is positioned transversely over the gluteal region, at the level of the ischial spine Sonoanatomy Key landmarks: Ischial spine (hyperechoic bony structure with acoustic shadow); Sacrospinous ligament; Sacrotuberous ligament; Internal pudendal artery (identified with Doppler). The pudendal nerve is located medial and posterior to the internal pudendal artery between the sacrospinous and sacrotuberous ligaments. It may appear as a small hyperechoic oval structure, although visualization is variable.\n\nNeedle Insertion Approach: in-plane, usually lateral-to-medial; Needle: 50 or 80 mm echogenic needle. The needle is advanced through the gluteal muscles, toward the ischial spine region, Into the interligamentous plane (between sacrospinous and sacrotuberous ligaments) Injection 6 mL of local anesthetic is injected per side. The spread of LA expands of the interligamentous space, circumferential spread around the pudendal artery controlled by Color echo doppler Sample Size: Assuming a mean 48h opioid consumption at 60 mg MME with a standard deviation: 30 mg and a clinically meaningful difference of 15 mg (25% reduction) with an Alpha risk : 0.05 (two-sided) and a β risk Power: 80%, the required sample is 64 patients per group. Accounting for 10% dropout the Total sample size: 140 patients (70 per group).\n\nAnalysis of the Population: Intention-to-treat (ITT) (primary analysis) and Per-protocol (sensitivity analysis) Descriptive Statistics: Continuous variables: mean ± SD or median (IQR) and Categorical variables: n (%)\n\nPrimary Outcome Analysis:\n\nComparison of cumulative MME at 48 h: If normally distributed → Student's t-test; If non-normal → Mann-Whitney U test Additionally: Linear regression adjusted for: Age, Sex, Surgical technique, Baseline pain Effect size: Mean difference with 95% confidence interval\n\nSecondary Analyses :\n\nPain scores (repeated measures): Mixed-effects linear models ; Fixed effects: group, time, group × time interaction; Random intercept for patient\n\nTime-to-event outcomes:\n\nTime to first opioid: Kaplan-Meier analysis; Log-rank test; Cox proportional hazards model\n\nCategorical outcomes:\n\nChi-square or Fisher's exact test; Report relative risks with 95% CI\n\nContinuous outcomes:\n\nt-test or Mann-Whitney depending on distribution Handling Missing Data : Multiple imputation if \\>5% missing; Sensitivity analyses Significance Threshold : p \\\u003C 0.05 (two-sided) Randomization Randomization and Blinding : Allocation ratio: 1:1; Computer-generated random sequence with variable block sizes; Allocation concealment via secure electronic system\n\nBlinding:\n\nThe patients are blinded; Outcome assessors: blinded; Data analysts: blinded; Performing anesthesiologist: not blinded Data Collection Methods: Pain opiates consumption and functional outcomes will be assessed at predefined time points using scales and validated questionnaires: NRS pain score at rest and during movement, .Lickert scale for patient satisfaction, consumption of rescue analgesia opiates (MME), Brief Pain Inventory and QOR 15 form. Data will be collected during follow-up visits or via structured interviews.",[66,72],{"label":67,"type":68,"description":69,"interventionNames":70},"Transgluteal pudendal nerve block","EXPERIMENTAL","Ultrasound-guided bilateral transgluteal pudendal nerve block performed at the level of the ischial spine before pudendal nerve division.",[71],"Procedure: Transgluteal Pudendal Nerve Block",{"label":73,"type":74,"description":75,"interventionNames":76},"Transperineal Pudendal Nerve Block","ACTIVE_COMPARATOR","Ultrasound-guided bilateral transperineal pudendal nerve block performed within the ischiorectal fossa near Alcock's canal.",[77],"Procedure: Transperineal pudendal nerve block",[79,84],{"type":80,"name":81,"description":82,"armGroupLabels":83,"otherNames":52},"PROCEDURE","Transgluteal Pudendal Nerve Block","Participants will receive bilateral ultrasound-guided posterior transgluteal pudendal nerve blocks under standardized general anesthesia. With the patient prone or in lateral decubitus, the gluteal region will be prepared aseptically. Ultrasound and color Doppler will identify the ischial spine, sacrospinous and sacrotuberous ligaments, and internal pudendal artery. An in-plane needle will be advanced into the interligamentous target plane, followed by injection of 5 mL ropivacaine 0.5% on each side. Local anesthetic spread will be assessed sonographically. Postoperative analgesia will include paracetamol and celecoxib when appropriate, with rescue opioids given for NRS pain \\>3\u002F10. Opioid consumption will be converted to morphine milligram equivalents (MME) for analysis.",[67],{"type":80,"name":85,"description":86,"armGroupLabels":87,"otherNames":52},"Transperineal pudendal nerve block","Participants will receive bilateral ultrasound-guided transperineal pudendal nerve blocks following standardized general anesthesia. In lithotomy position, the perineum will be prepared aseptically. A high-frequency ultrasound probe will identify the relevant anatomical structures and the internal pudendal artery using Color Doppler. An echogenic needle will be advanced under ultrasound guidance into the ischioanal\u002Fischiorectal fossa adjacent to the internal pudendal artery. After aspiration, 8 mL of 0.5% ropivacaine will be injected on each side, with ultrasound assessment of anesthetic spread. Postoperative analgesia will consist of standardized paracetamol and celecoxib. Rescue opioids will be administered for pain \\>3\u002F10 and converted to morphine milligram equivalents (MME) for analysis.",[73],[89,94],{"name":90,"role":91,"phone":92,"phoneExt":52,"email":93},"Philippe B Macaire, MD","CONTACT","+84 0966103845","ph.macaire@gmail.com",{"name":95,"role":91,"phone":96,"phoneExt":52,"email":97},"Nguyen H Thoai, MD","+84 0974944472","v.thoainh3@vinmec.com",{"type":99,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","100655387","pudendal-nerve-block-techniques-for-pain-control-after-hemorrhoidectomy-100655387",false,"NCT07813338","Pudendal Nerve Block Techniques for Pain Control After Hemorrhoidectomy","Transgluteal Versus Transperineal Pudendal Nerve Block for Analgesia After Hemorrhoidectomy: A Randomized Superiority Trial (The PINPOINT Trial)","PINPOINT","Inclusion Criteria\n\n* Adults aged 18 years or older.\n* Scheduled for elective hemorrhoidectomy.\n* Hemorrhoidectomy performed using either the Milligan-Morgan or Ferguson technique.\n* ASA Physical Status I-III.\n* Able to understand the study procedures and provide written informed consent.\n* Able to complete postoperative pain and quality-of-recovery assessments.\n\nExclusion Criteria\n\n* Chronic opioid use exceeding 30 mg morphine milligram equivalents per day.\n* Known allergy or contraindication to local anesthetics.\n* Coagulopathy or other contraindication to peripheral nerve block.\n* Infection at the planned injection site.\n* Pregnancy.\n* Cognitive impairment preventing reliable completion of study questionnaires or pain assessments.","ALL","18 Years",{"count":111,"type":112},140,"ESTIMATED","INTERVENTIONAL",[115],"NA","Hemorrhoidectomy is frequently associated with severe postoperative pain despite multimodal analgesia. Ultrasound-guided pudendal nerve block has become an effective regional analgesic technique, but it remains unknown whether blockade performed proximally at the ischial spine provides superior analgesia compared with the more distal transperineal approach.\n\nThe PINPOINT Trial is a prospective randomized assessor-blinded superiority trial comparing ultrasound-guided transgluteal (proximal) and transperineal (distal) pudendal nerve block in adults undergoing elective hemorrhoidectomy. The primary objective is to determine whether the proximal approach reduces cumulative opioid consumption during the first 48 postoperative hours. Secondary outcomes include pain intensity, opioid-related outcomes, recovery, complications, and patient-reported outcomes.",[118,119],"Hemorrhoids","Postoperative Pain",[121,122,123,124,119,125,126],"Hemorrhoidectomy","Pudendal Nerve Block","Regional Anesthesia","Ultrasound-Guided Nerve Block","Opioid Consumption","Enhanced Recovery","NOT_YET_RECRUITING","2026-09-07",{"date":130,"type":131},"2026-09-10","ACTUAL",{"date":133,"type":112},"2026-09-15",{"date":135,"type":112},"2027-09-30",{"name":5,"class":6}]