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Transgluteal versus transperineal pudendal nerve block for analgesia after hemorrhoidectomy: a randomized superiority trial (The PINPOINT trial)

NCT ID NCT07813338

NEW Sponsor: Vinmec Healthcare System Source: ClinicalTrials.gov ↗

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Stopped early
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Cancelled before anyone took part.

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Approved
The treatment has been approved, so it is available normally rather than through this programme.

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Status unknown
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First seen Sep 10, 2026 · Last updated Sep 10, 2026

Summary

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * 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. * Able to understand the study procedures and provide written informed consent. * Able to complete postoperative pain and quality-of-recovery assessments. Exclusion Criteria * 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. * Pregnancy. * Cognitive impairment preventing reliable completion of study questionnaires or pain assessments.

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Conditions

The condition(s) this trial relates to.

hemorrhoid Pain, Postoperative

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemorrhoids Postoperative pain

How to take part

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  1. The official record

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