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Not yet recruiting NCT07015775

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

No phase Interventional Hemorrhoids

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Neurostimulation, Ultrasound.
Who it may be relevant to
Registry conditions: Hemorrhoids. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure Neurostimulation
    Procedure guided by neurostimulation
  • Procedure Ultrasound
    Procedure guided by ultrasound

Primary outcome measures

  • Postoperative Pain assessment in the Post-Anesthesia Care Unit (PACU) [Time frame: Hour 2]
Secondary outcome measures (12)
  • Quantitative Opioid Consumption [Time frame: Hour 2]
  • Qualitative Opioid Consumption [Time frame: Hour 2]
  • Postoperative recovery assessment [Time frame: Day 1]
  • Postoperative recovery assessment [Time frame: Day 3]
  • Postoperative recovery assessment [Time frame: Day 7]
  • Postoperative Pain assessment at rest [Time frame: Day 1]
  • Postoperative Pain assessment at rest [Time frame: Day 3]
  • Postoperative Pain assessment at rest [Time frame: Day 7]
  • Postoperative Pain assessment during walking [Time frame: Day 1]
  • Postoperative Pain assessment during walking [Time frame: Day 3]
  • Postoperative Pain assessment during walking [Time frame: Day 7]
  • Postoperative Pain assessment during First defecation [Time frame: Day 7]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Hôpital Privé Claude Galien — Quincy-sous-Sénart

Publications

  • 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

Identifiers

NCT: NCT07015775 · 2025-A00534-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗