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NCT Number: NCT07350460

PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)

The goal of this clinical trial is to learn if the sacral erector spinae plane block can provide equal or better pain control than the pudendal nerve block in adults undergoing hemorrhoid surgery. The main question is: Which block offers more effective analgesia and faster recovery?

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Hemorrhoidectomy remains one of the most common anorectal procedures performed worldwide, yet it is frequently associated with significant postoperative pain that can impair recovery, delay discharge, and increase unplanned healthcare utilization. Effective analgesia is therefore a central component of perioperative care in this population.

Traditionally, the pudendal nerve block has been used to provide postoperative analgesia after hemorrhoidectomy. While effective, this technique requires precise anatomical identification, can be technically challenging, and is associated with potential risks such as vascular puncture or local anesthetic systemic toxicity. More recently, the sacral erector spinae plane (ESP) block has been described as a simpler, ultrasound-guided technique that may provide effective analgesia for procedures involving the perineal and anorectal region. Its safety profile and ease of performance could represent an attractive alternative to the pudendal nerve block, especially in the ambulatory setting.

The PUSHES trial is designed as a randomized, controlled, double-blind study to directly compare the efficacy of sacral ESP block versus pudendal nerve block for pain control after ambulatory hemorrhoidectomy. A total of 64 adult patients undergoing elective hemorrhoidectomy under standardized spinal anesthesia will be enrolled. Following spinal anesthesia, participants will be randomized to receive either a sacral ESP block with ropivacaine and a sham pudendal block with saline, or a pudendal block with ropivacaine and a sham sacral ESP block with saline. This double-dummy design ensures blinding of patients, anesthesiologists, and outcome assessors.

The primary endpoint is pain intensity at 4 hours postoperatively, measured using a 10-point Visual Analog Scale (VAS). Secondary endpoints include pain scores at 12 and 24 hours, time to first rescue analgesia, opioid consumption, functional recovery milestones (mobilization, ability to void, return to baseline activity), and block-related or systemic adverse events.

By systematically comparing these two techniques, this trial aims to identify whether the sacral ESP block can provide equivalent or superior analgesia to the pudendal nerve block while offering a simpler, safer alternative for routine clinical practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults (≥18 years old) scheduled for elective excisional hemorrhoidectomy;
  • Ability to understand the nature of the study and provide written informed consent;
  • American Society of Anesthesiologists (ASA) physical status I-III;
  • Ability to comply with study procedures and postoperative evaluations.

Exclusion criteria

  • Pregnancy;
  • Body weight under 50 kg due to the potential risk of local anaesthetic systemic toxicity (LAST);
  • BMI > 40; Known allergy or contraindication to local anaesthetics (e.g., ropivacaine, prilocaine);
  • Severe coagulation disorders or current anticoagulant therapy contraindicating spinal or peripheral deep nerve blocks (like pudendal block, because Sacral ESP is considered a superficial block);
  • Infection at the puncture site;
  • Neurological disorders affecting the sacral or pudendal nerve pathways;
  • Severe psychiatric conditions impairing study participation;
  • Language barriers

Treatment and study plan

Pudendal block AL

Procedure

Patients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine

Sacral ESP block AL

Procedure

Patients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine

Sacral ESP block Sham

Procedure

Patients in the control group will receive a sacral ESP block with 20 mL of normal saline.

Pudendal block Sham

Procedure

Patients will receive a bilateral pudendal nerve block with 20 mL of normal saline.

Primary outcomes

  1. Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0

    Time frame: Day 0

Secondary outcomes

  1. VAS (Visual Analogue Score) pain scores at 12 hours and 24 hours postoperatively

    Time frame: Day 0 and day 1

  2. Time to first request for rescue analgesia in 24 hours

    Time frame: Day 0 and day 1

  3. Total amount of rescue analgesia in 24 hours

    Time frame: Day 0 and day 1

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Lauretta, Dr. Med.

CONTACT

[email protected]

0041 (0)91 811 ext. 8182

Roberto Dossi, Dr. Med.

CONTACT

[email protected]

0041 (0)91 811 ext. 9341

Sponsors and collaborators

Lead sponsor

Andrea Saporito

Other

Registry information

Official study title

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

Acronym: PUSHES

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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