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

NCT07015775 | Not Yet Recruiting

• 1 other identifier: 2025-A00534-45
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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).

Conditions

Hemorrhoids

Keywords

hemorroidal surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU)

  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.

  Hour 2

Secondary Outcomes (19)

• Quantitative Opioid Consumption

  Hour 2

• Qualitative Opioid Consumption

  Hour 2

• Postoperative recovery assessment

  Day 1

• Postoperative recovery assessment

  Day 3

• Postoperative recovery assessment

  Day 7

Study Arms (2)

Pudendal block guided by neurostimulation

ACTIVE COMPARATOR

Neurostimulation involves using an electrical impulse to trigger a nerve signal and a specific motor response. A short-bevel, insulated 80 mm needle connected to a neurostimulator is used. The puncture point lies midway between the ischial tuberosity and the anus. Stimulation starts at 2.5 mA, 1 Hz, and the needle is advanced 4-5 cm until anal sphincter contraction occurs ("anal wink"). The needle is adjusted to maintain the response while reducing intensity to 0.5 mA. If lost, intensity is increased; if too intense at 0.3 mA, the needle is repositioned. After confirming no vascular puncture, 1 mL of Ropivacaine 3.5 mg/mL is injected to stop contraction, followed by slow injection of 15 mL total. The procedure is repeated on the other side. If no motor response occurs, a blind injection is performed after negative aspiration at 5 cm depth using the same landmarks.

Procedure: Neurostimulation

Pudendal block guided by ultrasound

EXPERIMENTAL

A 6 MHz convex probe is placed in the frontal plane along the line between the ischial tuberosity and the anal margin to visualize the bony prominence. The pudendal artery and nearby nerves are identified using color Doppler. A 22-gauge, 80 mm echogenic needle is inserted out-of-plane in front of the probe, targeting the lateral ischioanal fossa just medial to the pudendal artery, if visible. The probe is adjusted to center the artery. Block confirmation is based on ultrasound visualization of local anesthetic spreading into the fatty tissue medial to the pudendal artery. The procedure is repeated on the other side. If the artery is not visible, the injection is performed after negative aspiration on the medial aspect of the ischial tuberosity, along the line to the anus, at a depth of 4-5 cm.

Procedure: Ultrasound

Interventions

Neurostimulation PROCEDURE

Procedure guided by neurostimulation

Pudendal block guided by neurostimulation

Ultrasound PROCEDURE

Procedure guided by ultrasound

Pudendal block guided by ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location

Related Publications (1)

• Giral T, Maupain O, Elmaleh Y, Huynh D, Ciceron F, Yao K, Devidas P, El Metni A, Kutter J. Ultrasound-guided versus neurostimulation-guided bilateral transperineal pudendal nerve block for analgesia in outpatient haemorrhoid surgery: protocol for a multicentre, randomised, double-blind, non-inferiority trial. BJA Open. 2025 Dec 9;16:100512. doi: 10.1016/j.bjao.2025.100512. eCollection 2025 Dec.

  PMID: 41476689 DERIVED

MeSH Terms

Conditions

Hemorrhoids

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Thomas GIRAL, MD

  Hôpital privé Claude Galien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas GIRAL, MD

CONTACT

01 69 39 15 53; thomasgiral@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 3, 2025
• First Posted: June 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 8, 2026
• Study Completion (Estimated): August 8, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

FR (1)