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Completed

NCT Number: NCT06701162

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

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.

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Key information

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bechir Hamza hospital

Tunis, Tunis Governorate, 2001, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasoud-guided TAP block

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.

Ultrasound-guided Ilio-inguinal Ilio-Hypogatric block

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

Primary outcomes

  1. Quality of postoperative analgesia : PPMP score

    Time frame: 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 outcomes

  1. Block execution time

    Time frame: From the beginning of the practice of the block to the end

  2. Complications related to the techniques of nerve block

    Time frame: Perioperative

    Complications related to local anesthetics or block technique such as hematoma, spread of local anesthetic to the femoral nerve, intraperitoneal injection ...

Sponsors and collaborators

Lead sponsor

Tunis University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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