Clinical trial NCT07015775: Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery
Official title: Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemorrhoids
Keywords: hemorroidal surgery
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).
Primary purpose: TREATMENT

Brief 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).

Detailed description: This is a multicenter, prospective, randomized, double-blind study conducted on two parallel groups of patients undergoing hemorrhoidal surgery (pudendal block guided by neurostimulation versus pudendal block guided by ultrasound).

Study Duration The total study duration per patient is 7 days. The recruitment period is set at 12 months.

Justification of the Experimental Protocol The aim of this study is to compare two methods of performing a pudendal block. Patient allocation to either strategy will be determined by randomization. Bilateral pudendal nerve block and its branches in the ischioanal fossa will be performed after induction of general anesthesia.

To maintain double blinding, postoperative data will be collected by a physician other than the anesthesiologist performing the block, and by nursing staff under their supervision. None of these personnel will be informed of the patient's group allocation.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)
timeFrame: Hour 2
Secondary outcomes:
measure: Quantitative Opioid Consumption
timeFrame: Hour 2
measure: Qualitative Opioid Consumption
timeFrame: Hour 2
measure: Postoperative recovery assessment
timeFrame: Day 1
measure: Postoperative recovery assessment
timeFrame: Day 3
measure: Postoperative recovery assessment
timeFrame: Day 7
measure: Postoperative Pain assessment at rest
timeFrame: Day 1
measure: Postoperative Pain assessment at rest
timeFrame: Day 3
measure: Postoperative Pain assessment at rest
timeFrame: Day 7
measure: Postoperative Pain assessment during walking
timeFrame: Day 1
measure: Postoperative Pain assessment during walking
timeFrame: Day 3
measure: Postoperative Pain assessment during walking
timeFrame: Day 7
measure: Postoperative Pain assessment during First defecation
timeFrame: Day 7
measure: Non-Opioid Postoperative Medication Use
timeFrame: Day 1
measure: Pudendal block procedure duration
timeFrame: Hour 2
measure: Sensory block duration
timeFrame: Day 7
measure: Length of stay in the PACU
timeFrame: Day 1
measure: Total hospital stay duration
timeFrame: Day 1
measure: Time to first defecation
timeFrame: Day 7
measure: Tolerance
timeFrame: Day 7
Other outcomes:
Locations:
city: Quincy-sous-Sénart
country: France
facility: Hôpital Privé Claude Galien
Study officials:
affiliation: Hôpital privé Claude Galien
name: Thomas GIRAL, MD
role: PRINCIPAL_INVESTIGATOR
References: