Comparison of two pain relief methods in children undergoing surgery

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2026
INTERVENTION: Intervention1: Ultrasound guided Lumbar Erector Spinae Plane block: Pre‐operative Ultrasound‐guided Lumbar Erector Spinae Plane block administered as a single injection technique to Pediatric patients undergoing Unilateral Inguinal Hernia Surgery.The ultrasound guided block procedure is estimated to take approximately 5 to 10 minutes to perform. The estimated clinical duration of action for the postoperative analgesia provided by the block is approximately 8 to 12 hours. Patients will be continuously monitored for postoperative pain scores for a total duration of 24 hours post‐surgery. Control Intervention1: Ultrasound guided Ilioinguinal/Iliohypogastric nerve block: Pre‐operative Ultrasound‐guided Ilioinguinal/Iliohypogastric nerve block administered as a single injection technique to Pediatric patients undergoing Unilateral Inguinal Hernia Surgery for Postoperative analgesia. The ultrasound guided block procedure is estimated to take approximately 5 to 10 minutes to perform. The estimated clinical duration of action for the postoperative analgesia provided by the block is approximately 8 to 12 hours. Patients will be continuously monitored for postoperative pain scores for a total duration of 24 hours post‐surgery. CONDITION: Health Condition 1: O‐ Medical and Surgical PRIMARY OUTCOME: To assess the non‐inferiority of the mean duration of analgesia of Erector Spinae Plane block compared to Ilioinguinal/Iliohypogastric nerve blockTimepoint: The time to first rescue analgesia, which will be assessed continuously from baseline 0 hours upon arrival in the post‐Anesthesia care unit upto 24 hours postoperatively. The endpoint is recorded at the postoperative time when a child exhibits a FLACC score of 4 or greater, triggering rescue analgesic administration. SECONDARY OUTCOME: Mean changes in hemodynamic parameters like Heart rate, Mean arterial pressure in both the study groupsTimepoint: Baseline intraooperatively & at 0 minute,30 minute, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours postoperatively Mean FLACC pain score in both study groupsTimepoint: Evaluation of postoperative FLACC pain score at 0 minute, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 24 hours Mean parental satisfaction scoreTimepoint: At 24 hours postoperatively in both study groups Percentage of the patients experiencing adverse events or complicationsTimepoint: At 24 hours postoperatively in both study groups INCLUSION CRITERIA: Patients of American Society of Anaesthesiologists Physical Status I and II aged from 6 months to 12 years scheduled for elective unilateral Inguinal hernia repair
Epistemonikos ID: 6df8fa019044f2cd1d322e6ad56476c09ee04319
First added on: Oct 08, 2026