Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07350460

A Randomized, Double-Blind Trial Comparing Pudendal Block Versus Sacral ESP for Ambulatory Hemorrhoidectomy

Led by Andrea Saporito · Updated on 2026-03-18

64

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether the sacral erector spinae plane (ESP) block provides equal or better pain relief compared to the pudendal nerve block in adults undergoing hemorrhoid surgery. This trial focuses on which block offers more effective pain control and faster recovery after ambulatory hemorrhoidectomy. The study is a randomized, controlled, double-blind trial designed to compare these two pain management techniques. Participants will be randomly assigned to receive either an ultrasound-guided sacral ESP block with ropivacaine and a placebo pudendal nerve block with saline, or a pudendal nerve block with ropivacaine and a placebo sacral ESP block with saline. Both blocks involve a 20 mL injection of either 0.75% ropivacaine or saline. This double-dummy design maintains blinding for patients, anesthesiologists, and outcome assessors. The study includes 64 adult patients undergoing elective hemorrhoidectomy under spinal anesthesia. Throughout the study, participants will be assessed for pain intensity using a 10-point Visual Analog Scale (VAS) at 4, 12, and 24 hours after surgery. Researchers will also monitor time to first rescue analgesia, total opioid use, recovery milestones like mobilization and ability to void, and any block-related or systemic adverse events. The total participation lasts through the immediate postoperative period with assessments continuing up to 24 hours after surgery to evaluate the effectiveness and safety of each block.

CONDITIONS

Brief Title

PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years or older scheduled for elective excisional hemorrhoidectomy
  • Ability to understand the study and provide written informed consent
  • Physical status classified as American Society of Anesthesiologists (ASA) I-III
  • Ability to follow study procedures and complete postoperative evaluations
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Body weight under 50 kg due to risk of local anesthetic systemic toxicity
  • Body mass index (BMI) over 40
  • Known allergy or contraindication to local anesthetics such as ropivacaine or prilocaine
  • Severe coagulation disorders or current anticoagulant therapy contraindicating spinal or deep nerve blocks
  • Infection at the injection site
  • Neurological disorders affecting sacral or pudendal nerves
  • Severe psychiatric conditions that impair study participation
  • Language barriers preventing informed consent or compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Treatment

Duration - Day 0 (day of surgery)

Participants undergo ambulatory hemorrhoidectomy under spinal anesthesia and receive either a pudendal nerve block or a sacral ESP block for postoperative pain control.

1 visit (in-person) on the day of surgery

Follow-up

Duration - Up to 24 hours postoperatively

Participants are monitored for pain intensity, rescue analgesia use, and recovery milestones up to 24 hours after surgery.

1 follow-up visit or contact within 24 hours after surgery

Trial Site Locations

Total: 1 location

1

Ospedale Regionale Bellinzona e Valli (ORBV) CH-6500 Bellinzona Switzerland

Bellinzona, Switzerland, 6500

Actively Recruiting

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Research Team

R

Roberto Dossi, Dr. Med.

A

Alessandra Lauretta, Dr. Med.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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