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
Abstract
Background: Haemorrhoid surgery is often associated with severe postoperative pain. Bilateral transperineal pudendal nerve block, performed using anatomical landmarks or nerve stimulation, is effective and currently recommended for postoperative analgesia. However, these blind techniques carry risks such as pudendal artery puncture or rectal injury and are not always routinely performed. The ultrasound-guided transperineal pudendal nerve block has shown promise in paediatric urological surgery, appearing both effective and well tolerated, but has not yet been evaluated in proctological procedures.
Methods: This multicentre, prospective, randomised, double-blind trial aims to compare the analgesic efficacy, adverse effects, and safety of ultrasound-guided vs nerve stimulator-guided bilateral transperineal pudendal nerve block in patients undergoing haemorrhoid surgery. The primary endpoint is the maximum pain score (0-10 numerical rating scale) in the post-anaesthesia care unit. Secondary outcomes include length of stay in post-anaesthesia care unit and hospital, quality of recovery score (QoR-15 score), pain and analgesic medication consumption during the first 7 days, and treatment-related adverse effects and safety. A total of 202 patients are required to test non-inferiority, based on a predefined margin of 0.7. The study received ethical approval from the Comité de Protection des Personnes Ouest IV in May 2025.
Conclusions: Recruitment is expected to begin in September…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 202 participants or records.
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