Comparison of ultrasound guided retrolaminar block versus caudal block for postoperative analgesia in paediatric patients undergoing unilateral inguinal hernia surgery: A double-blinded randomized controlled non-inferiority trial

This is a prospective randomized double blind parallel group active controlled non inferiority clinical trial conducted at the All India Institute of Medical Sciences New Delhi. A total of sixty six pediatric patients aged two to ten years undergoing unilateral open inguinal hernia surgery under general anesthesia will be randomly allocated using a computer generated random number sequence into two groups of thirty three each. Group A will receive ultrasound guided caudal block and Group B will receive ultrasound guided retrolaminar block. Participants children and parents and the outcome assessor will remain blinded to group allocation.

Postoperative pain will be assessed using the FLACC scale Face Legs Activity Cry Consolability at rest and during movement at one two four and six hours after surgery. The primary outcome will be the FLACC score at six hours at rest. Secondary outcomes include FLACC scores at other time points intra and postoperative fentanyl requirement time to first rescue analgesia total rescue analgesic consumption block related complications Modified Post Anaesthesia Discharge Score at discharge and parental satisfaction.

Rescue analgesia with intravenous fentanyl which will be given if FLACC score is more than four. As this is a day care surgery children will be discharged after six to eight hours once Modified PADS score is nine or above. At home parents will give syrup ibuprofen ten milligram per kilogram every eight hours as needed. On the next day parents will be contacted telephonically to ask about pain control excess use of ibuprofen and return to normal activity.

The study aims to determine whether the retrolaminar block is non inferior to the caudal block in providing safe and effective postoperative pain relief in children undergoing day care inguinal hernia surgery.