Clinical trial

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

Name

36264PR352/9/23

Description

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.

Trial arms

Trial start

2023-10-24

Estimated PCD

2024-04-21

Trial end

2024-04-21

Status

Completed

Treatment

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.

Arms:

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.

Arms:

Laparoscopic-assisted transversus abdominis plane block

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.

Arms:

Laparoscopic-assisted intraperitoneal instillation

Bupivacaine

bupivacaine

Arms:

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

Size

Primary endpoint

Total postoperative pethidine consumption

24 hours postoperatively

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 66, 'type': 'ACTUAL'}}

Updated at

2024-04-25

1 organization

1 product

6 indications

Organization

Tanta University

Product

Bupivacaine

Indication

Laparoscopic

Indication