Evaluation of the Analgesic Efficacy of an Ultrasound-guided Transperineal Pudendal Block in Outpatient Hemorrhoidal Surgery

Not Applicable

Not yet recruiting

• Conditions: Hemorrhoids

• Registration Number: NCT07015775
• Lead Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-03
• Study First Submitted QC: 2025-06-03
• Last Update Submitted: 2025-06-03
• Study First Posted: 2025-06-11
• Last Update Posted: 2025-06-11
• Study Start: 2025-08-01
• Primary Completion: 2026-08-08
• Study Completion: 2026-08-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 202

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)	Hour 2	The primary endpoint of the study is the maximum pain score in the Post-Anesthesia Care Unit (PACU) before morphine titration.; Postoperative pain in the recovery room will be recorded by the nursing staff using a simple numeric scale from 0 to 10 after questioning the patient, following standard departmental procedures. The maximum pain score before morphine titration constitutes the primary evaluation criterion.

Secondary Outcome Measures

Name	Time	Method
Quantitative Opioid Consumption	Hour 2	Mean amount of morphine administered in each group
Qualitative Opioid Consumption	Hour 2	Percentage of patients in each group with zero morphine use
Postoperative recovery assessment	Day 7	QOR-15 accurately assesses postoperative recovery across five key domains: pain, physical comfort, physical independence, psychological support, and emotional state. Each item is rated from 0 (poor) to 10 (excellent), with a total score ranging from 0 (no recovery) to 150 (full recovery).
Postoperative Pain assessment at rest	Day 7	Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Postoperative Pain assessment during walking	Day 7	Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Postoperative Pain assessment during First defecation	Day 7	Postoperative pain will be measured by nursing staff during the patient's ambulatory stay, and the maximum score will be recorded in the Case Report Form (CRF). Pain will be self-reported by the patient using a simple numeric scale from 0 to 10.
Non-Opioid Postoperative Medication Use	Day 1	Use of non-opioid analgesics and antiemetics during hospitalization. Use of analgesics as reported by the patients.
Pudendal block procedure duration	Hour 2	Duration of pudendal block procedure
Sensory block duration	Day 7	Duration of sensory block
Length of stay in the PACU	Day 1	Length of stay in the PACU
Total hospital stay duration	Day 1	Total hospital stay duration
Time to first defecation	Day 7	Time to first defecation
Tolerance	Day 7	Procedure tolerance will be assessed by recording all adverse events (serious or non-serious) with a potential causal link to analgesia

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France