PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study) (PUSHES)

March 16, 2026 updated by: Andrea Saporito

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Bellinzona, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli (ORBV) CH-6500 Bellinzona Switzerland
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pudendal block
Patients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine and a sacral ESP block with 20 mL of normal saline. Blinding is ensured by the double block procedure
Procedure: Pudendal block AL
Patients in the control group will receive an ultrasound-guided bilateral pudendal nerve block with 20 mL of 0.75% ropivacaine
Procedure: Sacral ESP block Sham
Patients in the control group will receive a sacral ESP block with 20 mL of normal saline.
Experimental: Sacral ESP block
Patients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine and a bilateral pudendal nerve block with 20 mL of normal saline.
Procedure: Sacral ESP block AL
Patients in the intervention group will receive an ultrasound-guided sacral ESP block with 20 mL of 0.75% ropivacaine
Procedure: Pudendal block Sham
Patients will receive a bilateral pudendal nerve block with 20 mL of normal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain intensity, assessed using the Visual Analogue Scale (VAS) at 4 hours following surgery in day 0
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS (Visual Analogue Score) pain scores at 12 hours and 24 hours postoperatively
Time Frame: Day 0 and day 1
Day 0 and day 1
Time to first request for rescue analgesia in 24 hours
Time Frame: Day 0 and day 1
Day 0 and day 1
Total amount of rescue analgesia in 24 hours
Time Frame: Day 0 and day 1
Day 0 and day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andrea Saporito

Investigators

  • Study Chair: Andrea Saporito, Prof. Dr. Med., Department of Anesthesiology, Ospedale San Giovanni, Ente Ospedaliero Cantonale, Bellinzona, Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 5, 2026

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

December 30, 2025

First Submitted That Met QC Criteria

January 10, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PUSHES trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) will be shared upon reasonable request from qualified investigators by contacting the Principal Investigator via email. Due to the double-blind design of the study, raw data will not be shared before study completion, unblinding, and final statistical analyses. Following these steps, de-identified individual-level data may be made available to support requests aimed at verifying or challenging the reported findings, subject to appropriate scientific justification and compliance with applicable data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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