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Clinical Trials/NCT06098105
NCT06098105
Completed
Not Applicable

Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics Undergoing Inguinal Hernia Repair: A Randomized Controlled Trial

Tanta University1 site in 1 country66 target enrollmentOctober 24, 2023

Overview

Phase
Not Applicable
Intervention
Bupivacaine
Conditions
Laparoscopic
Sponsor
Tanta University
Enrollment
66
Locations
1
Primary Endpoint
Total postoperative pethidine consumption
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 24, 2023
End Date
April 21, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ِAhmed Mohamed Ibrahim

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

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).

Arms & Interventions

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.

Intervention: Bupivacaine

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.

Intervention: Ultrasound-guided 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.

Intervention: 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.

Intervention: Bupivacaine

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.

Intervention: 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.

Intervention: Bupivacaine

Outcomes

Primary Outcomes

Total postoperative pethidine consumption

Time Frame: 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 Outcomes

  • Post-operative pain scores(24 hours postoperatively)
  • Time of first analgesia request.(24 hours postoperatively)
  • Incidence of adverse events(24 hours postoperatively)

Study Sites (1)

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