Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics

Not Applicable

Completed

• Conditions: Laparoscopic; Pediatrics; Ultrasound; Laparoscopic Intraperitoneal Instillation; Inguinal Hernia Repair; Transversus Abdominis Plane Block
• Interventions: Procedure: Ultrasound-guided transversus abdominis plane block; Procedure: Laparoscopic-assisted transversus abdominis plane block; Procedure: Laparoscopic-assisted intraperitoneal instillation; Drug: Bupivacaine

• Registration Number: NCT06098105
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to compare laparoscopic -assisted, ultrasound-guided transversus abdominis plane block and laparoscopic intraperitoneal instillation of local anesthetic in pediatrics undergoing inguinal hernia repair.

Detailed Description

Inguinal hernia is one of the most common pediatric surgeries. Effective and safe pain management causes fewer side effects and enables faster hospital discharge. It is also important in overcoming chronic pain in the late postoperative period.

Transversus abdominis plane block (TAPB) has emerged as a safe, simple, and inexpensive modality incorporated into many enhanced recovery pathways to achieve narcotic-sparing analgesia after bariatric surgery. TAPB was first performed through the lumbar triangle of Petit in 2001. Since that time, both ultrasound-guided (US) and laparoscopic (LAP) TAPBs have been developed to aid in proper identification of the correct plane and minimize peritoneal penetration.

Study Timeline

• Study First Submitted: 2023-10-19
• Study First Submitted QC: 2023-10-23
• Study Start: 2023-10-24
• Study First Posted: 2023-10-24
• Status Verified: 2024-04
• Primary Completion: 2024-04-21
• Study Completion: 2024-04-21
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Age: 2 months to 7 years old
• Both sexes.
• American Society of Anesthesiologists (ASA) I-II.
• Schedule for elective unilateral inguinal hernia repair.

Exclusion Criteria

• Patients with history of allergy.
• Hepatic and renal failure.
• Previous inguinal surgery.
• Block contraindications (e.g., infection at the site of block, bleeding disorder, or abnormalities of the sacrum).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laparoscopic-assisted transversus abdominis plane block	Bupivacaine	Patients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.
Ultrasound-guided transversus abdominis plane block	Ultrasound-guided transversus abdominis plane block	This group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.
Laparoscopic-assisted transversus abdominis plane block	Laparoscopic-assisted transversus abdominis plane block	Patients will receive Laparoscopic-assisted transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL.
Laparoscopic-assisted intraperitoneal instillation	Laparoscopic-assisted intraperitoneal instillation	This group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.
Ultrasound-guided transversus abdominis plane block	Bupivacaine	This group will receive Ultrasound-guided transversus abdominis plane block by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL as a control group.
Laparoscopic-assisted intraperitoneal instillation	Bupivacaine	This group will receive Laparoscopic-assisted intraperitoneal instillation by using 1 ml/kg of bupivacaine 0.25% with a maximum volume of 20 mL will be instilled into the peritoneal cavity immediately after gas insufflation.

Primary Outcome Measures

Name	Time	Method
Total postoperative pethidine consumption	24 hours postoperatively	The patient will be given supplementary paracetamol I.V. injection in a dose of 15 mg/kg as routine analgesia. If the FLACC score is \> 3, pethidine 0.5 mg/kg.

Secondary Outcome Measures

Name	Time	Method
Post-operative pain scores	24 hours postoperatively	Face, Legs, Activity, Cry and Consolability (FLACC) scale will be used for postoperative pain assessment. This scale ranges from 0 to 10 where 0 represents no pain and 10 represents worst possible pain.; FLACC scale will be measured at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours.
Time of first analgesia request.	24 hours postoperatively	Time of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia.
Incidence of adverse events	24 hours postoperatively	Complication related to the block or adverse events of the administered drugs.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt