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Pudendal Nerve Block Techniques for Pain Control After Hemorrhoidectomy

ConditionsHemorrhoidsPostoperative Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVinmec Healthcare System

About this trial

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.

The 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 years or older.

Scheduled for elective hemorrhoidectomy.

Hemorrhoidectomy performed using either the Milligan-Morgan or Ferguson technique.

ASA Physical Status I-III.

Disqualifiers

Chronic opioid use exceeding 30 mg morphine milligram equivalents per day.

Known allergy or contraindication to local anesthetics.

Coagulopathy or other contraindication to peripheral nerve block.

Infection at the planned injection site.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transgluteal Pudendal Nerve Block

    Procedure/Surgery

    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 \>3/10. Opioid consumption will be converted to morphine milligram equivalents (MME) for analysis.

  • Transperineal pudendal nerve block

    Procedure/Surgery

    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/ischiorectal 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 \>3/10 and converted to morphine milligram equivalents (MME) for analysis.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Transgluteal pudendal nerve blockExperimental treatment 1 intervention
Group B: Transperineal Pudendal Nerve BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Post operative From the end of surgery to 48 hours after surgery

Secondary outcomes

1

post operative pain intensity at rest

Pain intensity at rest measured by Visual Analogic Scale (VAS) ruller.

Time frame
post operative at 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after end of surgery
2

Post operative pain intensity during defecation

Pain Intensity during defecation using Visual Analogic Scale (VAS) ruler

Time frame
at the first post operative defecation and during the first 48 hours post operative observation period.
3

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.

Time frame
from end of the surgery to 48 hours after surgery
4

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)

Time frame
Post operative : at 12 hours, 24 hours and 36 Hours after the surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vinmec Healthcare System

Lead sponsor

Source ClinicalTrials.gov

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