PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)

Andrea Saporito

Status: Not yet enrolling

Conditions: Hemorrhoids Third Degree; Hemorrhoids

Treatments: Procedure: Sacral ESP block Sham; Procedure: Sacral ESP block AL; Procedure: Pudendal block AL; Procedure: Pudendal block Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT07350460

PUSHES trial

Details and patient eligibility

About

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?

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

Pudendal block

Active Comparator group

Description:

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

Treatment:

Procedure: Pudendal block AL

Procedure: Sacral ESP block Sham

Sacral ESP block

Experimental group

Description:

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.

Treatment:

Procedure: Pudendal block Sham

Procedure: Sacral ESP block AL