RecruitingNot Applicable

PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)

Switzerland64 participantsStarted 2026-01-05

Plain-language 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?

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Day 0

Trial details

NCT IDNCT07350460

SponsorAndrea Saporito

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-29

Contact for this trial

Roberto Dossi, Dr. Med.

0041 (0)91 811 Roberto.Dossi@eoc.ch

View on ClinicalTrials.gov More Hemorrhoids trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.