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Recruiting NCT07350460

NCT07350460 PUSHES (Pudendal Block Versus Sacral ESP Hemorrhoidectomy Study)

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Clinical Trial Summary
NCT ID NCT07350460
Status Recruiting
Phase
Sponsor Andrea Saporito
Condition Hemorrhoids
Study Type INTERVENTIONAL
Enrollment 64 participants
Start Date 2026-01-05
Primary Completion 2027-09-29

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 80 Years
Study Type INTERVENTIONAL
Interventions
Pudendal block ALSacral ESP block ALSacral ESP block Sham

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 64 participants in total. It began in 2026-01-05 with a primary completion date of 2027-09-29.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 Criteria

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

Contact & Investigator

Central Contact

Roberto Dossi, Dr. Med.

✉ Roberto.Dossi@eoc.ch

📞 0041 (0)91 811

Principal Investigator

Andrea Saporito, Prof. Dr. Med.

STUDY CHAIR

Department of Anesthesiology, Ospedale San Giovanni, Ente Ospedaliero Cantonale, Bellinzona, Switzerland

Frequently Asked Questions

Who can join the NCT07350460 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hemorrhoids. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07350460 currently recruiting?

Yes, NCT07350460 is actively recruiting participants. Contact the research team at Roberto.Dossi@eoc.ch for enrollment information.

Where is the NCT07350460 trial being conducted?

This trial is being conducted at Bellinzona, Switzerland.

Who is sponsoring the NCT07350460 clinical trial?

NCT07350460 is sponsored by Andrea Saporito. The principal investigator is Andrea Saporito, Prof. Dr. Med. at Department of Anesthesiology, Ospedale San Giovanni, Ente Ospedaliero Cantonale, Bellinzona, Switzerland. The trial plans to enroll 64 participants.

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