Superior hypogastric plexus block to enhance recovery after laparoscopic hysterectomy: study protocol for the SUBTLE randomised controlled trial

Enhanced recovery after surgery pathways for laparoscopic hysterectomy reduce incisional and somatic pain, yet pelvic visceral pain related to uterine manipulation, peritoneal traction, pneumoperitoneum and presacral or pelvic dissection may remain clinically important. The superior hypogastric plexus conveys pelvic visceral nociceptive afferents and can be accessed under direct laparoscopic vision. Existing trials of intraoperative superior hypogastric plexus block (SHPB) have reported variable analgesic effects, and rigorously masked evidence focused on patient-centred recovery is limited. SUBTLE (SUperior hypogastric plexus Block To enhance recovery after Laparoscopic hysterEctomy) is a single-centre, randomised, parallel-group, quadruple-masked, placebo-controlled superiority trial. Women aged 18–70 years scheduled for laparoscopic hysterectomy for benign indications are randomised 1:1 to receive surgeon-performed intraoperative SHPB with either 20 mL of 0.75% ropivacaine hydrochloride or 20 mL of 0.9% normal saline. The target sample size is 198 participants. The primary outcome is Quality of Recovery-15 (QoR-15) score on postoperative day 1. Secondary outcomes include QoR-15 through postoperative day 2, postoperative pain intensity, opioid consumption, postoperative nausea and vomiting, post-anaesthesia care unit length of stay, longer-term Brief Pain Inventory and McGill Pain Questionnaire outcomes through postoperative day 90, and block-related adverse events. This trial will determine whether adding a procedurally standardised visceral nerve block to contemporary perioperative recovery care improves early global recovery after laparoscopic hysterectomy. Positive findings would support SHPB as a practical visceral analgesic component of enhanced recovery pathways; neutral findings would help define the limits of adding laparoscopic presacral blockade to multimodal analgesia. ClinicalTrials.gov, NCT06455540. Registered on 13 June 2024.