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

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

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).

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.

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