TRANSVERSE ABDOMINAL PLANE BLOCK VS. ILIO-INGUINAL ILIO-HYPOGASTRIC BLOCK in PEDIATRIC INGUINAL SURGERY

Not Applicable

Completed

• Conditions: Analgesia; Ultrasound Guided Block

• Registration Number: NCT06701162
• Lead Sponsor: Tunis University

Brief Summary

The ilio-inguinal ilio-hypogastric (IIIH) nerve block remains the gold standard analgesic technique after inguinal surgery in children. Transverse abdominal plane (TAP) block has been reported to provide effective analgesia after lower abdominal surgery in adults. The aim of our study was to compare the analgesic effect of ultrasound-guided TAP block to IIIH nerve block after inguinal surgery in children.

Detailed Description

The study aimed to compare the analgesic effect of ultrasound-guided transverse abdominal plane (TAP) block to ilio-inguinal ilio-hypogastric (IIIH) nerve block in children after inguinal surgery. This prospective, randomized study included children aged six months to twelve years, classified as ASA I or II, scheduled for elective unilateral inguinal surgery. Participants received either a TAP block or an IIIH block with bupivacaine following standardized induction of general anesthesia. Analgesics were not systematically administered post-induction. Postoperative pain was monitored for six hours in the hospital, and if the CHEOPS score exceeded 7, paracetamol was administered, with nalbuphine as a secondary option if needed. At home, parents assessed pain using the PPMP score, administering paracetamol and ibuprofen if necessary. Primary outcomes included postoperative analgesia quality, determined by time to first analgesic requirement and the need for analgesics at hospital and home. Secondary outcomes measured included block performance duration, parental satisfaction, and incidence of complications.

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2020-02-27
• Study Completion: 2020-02-27
• Status Verified: 2024-11
• Study First Submitted: 2024-11-14
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children aged 6 months to 12 years
• ASA physical status 1 or 2
• Scheduled for unilateral inguinal surgery

Exclusion Criteria

• Children scheduled for bilateral surgery or associated procedures (e.g., circumcision)
• Parental refusal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Quality of postoperative analgesia : PPMP score	24 h after surgery	The quality of postoperative analgesia described by the pain score : Postoperative Pain Measure for Parents (PPMP) score, minimum value is 0 , maximum value 10 , a value higher than 6 indicates a major pain .

Secondary Outcome Measures

Name	Time	Method
Block execution time	From the beginning of the practice of the block to the end
Complications related to the techniques of nerve block	Perioperative	Complications related to local anesthetics or block technique such as hematoma, spread of local anesthetic to the femoral nerve, intraperitoneal injection ...

Trial Locations

Locations (1)

Bechir Hamza hospital; 🇹🇳 Tunis, Tunisia