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

NCT ID: NCT06701162

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-02-27

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.

Conditions

Analgesia; Ultrasound Guided Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

TAP group

Uktrasound-guided TAP block

Group Type: OTHER

Ultrasoud-guided TAP block

Intervention Type: PROCEDURE

the ultrasound probe was placed at the mid-axillary line, and the needle was inserted into the space between the internal oblique and transverse muscles, splitting the inter-muscular fascia after injection of local anesthetic.

IIIH block

Ultrasound-guided Ilio-inguinal Ilio-Hypogastric Block

Group Type: OTHER

Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block

Intervention Type: PROCEDURE

the ultrasound probe was positioned transversely on the abdominal wall at the contact point of the anterosuperior iliac spine. The needle was inserted into the space between the internal oblique and transverse muscles, causing separation of the intermuscular fascia layers upon injection of the anesthetic mixture

Interventions

Ultrasoud-guided TAP block

the ultrasound probe was placed at the mid-axillary line, and the needle was inserted into the space between the internal oblique and transverse muscles, splitting the inter-muscular fascia after injection of local anesthetic.

Intervention Type: PROCEDURE

Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block

the ultrasound probe was positioned transversely on the abdominal wall at the contact point of the anterosuperior iliac spine. The needle was inserted into the space between the internal oblique and transverse muscles, causing separation of the intermuscular fascia layers upon injection of the anesthetic mixture

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tunis University

OTHER

Sponsor Role: lead

Responsible Party

Mehdi Trifa

Head of the Department of Anesthesiology and Critical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bechir Hamza hospital

Tunis, Tunis Governorate, Tunisia

Countries

Tunisia

Other Identifiers

012020

Identifier Type: -

Identifier Source: org_study_id