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

NCT06098105 | Completed

• 1 other identifier: 36264PR352/9/23
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic; Ultrasound; Transversus Abdominis Plane Block; Laparoscopic Intraperitoneal Instillation; Pediatrics; Inguinal Hernia Repair

Outcome Measures

Primary Outcomes (1)

• Total postoperative pethidine consumption

  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.

  24 hours postoperatively

Secondary Outcomes (3)

• Post-operative pain scores

  24 hours postoperatively

• Time of first analgesia request.

  24 hours postoperatively

• Incidence of adverse events

  24 hours postoperatively

Study Arms (3)

Ultrasound-guided transversus abdominis plane block

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-guided transversus abdominis plane block; Drug: Bupivacaine

Laparoscopic-assisted transversus abdominis plane block

EXPERIMENTAL

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.

Procedure: Laparoscopic-assisted transversus abdominis plane block; Drug: Bupivacaine

Laparoscopic-assisted intraperitoneal instillation

EXPERIMENTAL

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.

Procedure: Laparoscopic-assisted intraperitoneal instillation; Drug: Bupivacaine

Interventions

Ultrasound-guided transversus abdominis plane block PROCEDURE

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.

Ultrasound-guided transversus abdominis plane block

Laparoscopic-assisted transversus abdominis plane block PROCEDURE

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 transversus abdominis plane block

Laparoscopic-assisted intraperitoneal instillation PROCEDURE

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.

Laparoscopic-assisted intraperitoneal instillation

Bupivacaine DRUG

bupivacaine

Laparoscopic-assisted intraperitoneal instillation; Laparoscopic-assisted transversus abdominis plane block; Ultrasound-guided transversus abdominis plane block

Eligibility Criteria

• Age: 2 Months - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 24, 2023
• Study Start: October 24, 2023
• Primary Completion: April 21, 2024
• Study Completion: April 21, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)