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

T

Tanta University

Status

Completed

Conditions

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

Treatments

Procedure: Laparoscopic-assisted intraperitoneal instillation
Procedure: Laparoscopic-assisted transversus abdominis plane block
Drug: Bupivacaine
Procedure: Ultrasound-guided transversus abdominis plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT06098105
36264PR352/9/23

Details and patient eligibility

About

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.

Full 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.

Enrollment

66 patients

Sex

All

Ages

2 months to 7 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

66 participants in 3 patient groups

Ultrasound-guided transversus abdominis plane block
Active Comparator group
Description:
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.
Treatment:
Procedure: Ultrasound-guided transversus abdominis plane block
Drug: Bupivacaine
Laparoscopic-assisted transversus abdominis plane block
Experimental group
Description:
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.
Treatment:
Procedure: Laparoscopic-assisted transversus abdominis plane block
Drug: Bupivacaine
Laparoscopic-assisted intraperitoneal instillation
Experimental group
Description:
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.
Treatment:
Procedure: Laparoscopic-assisted intraperitoneal instillation
Drug: Bupivacaine

Trial contacts and locations

1

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Central trial contact

Ahmed M Ibrahim, MD

Data sourced from clinicaltrials.gov

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