Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outp… (NCT07015775) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery
France202 participantsStarted 2025-08-01
Plain-language summary
In a population of patients undergoing hemorrhoidal surgery under general anesthesia and divided into two equal groups based on the method used for intraoperative pudendal nerve block and its branches in the ischioanal fossa:
Group 1: Pudendal block guided by neurostimulation Group 2: Pudendal block guided by ultrasound
The primary objective of this study is to compare the maximum immediate postoperative pain score between the two groups (pain reported by the patients in the recovery room on a simple numeric scale before morphine titration).
Who can participate
Age range
18 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:
* Adult male or female patient
* Patient who has signed informed consent to participate in the study
* Patient scheduled for outpatient hemorrhoidal surgery under general anesthesia
Exclusion Criteria:
* History of hemorrhoidal surgery
* Allergy or contraindication to any of the medications used in the study
* Patient undergoing surgery under spinal anesthesia
* History of chronic pain requiring opioid use, unrelated to hemorrhoids
* Mental impairment or any other condition that could hinder understanding or strict adherence to the protocol
* Patient not affiliated with the French national health insurance system
* Patient under legal protection (e.g., guardianship, trusteeship, or court protection)
* Pregnant woman or woman at risk of being pregnant (i.e., of childbearing age without effective contraception and without an HCG test)
* Patient already enrolled in another therapeutic clinical trial or within the exclusion period of another clinical trial
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
1
Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)
Timeframe: Hour 2
Trial details
NCT IDNCT07015775
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche