RecruitingNot ApplicableNCT07350460

PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)

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


Sponsor

Andrea Saporito

Enrollment

64 participants

Start Date

Jan 5, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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?


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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

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Interventions

PROCEDUREPudendal block AL

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

PROCEDURESacral ESP block AL

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

PROCEDURESacral ESP block Sham

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

PROCEDUREPudendal block Sham

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


Locations(1)

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

Bellinzona, Switzerland

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NCT07350460


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