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NCT Number: NCT06098105

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

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.

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Key information

Conditions

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

Age range

2 month–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

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 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.

Bupivacaine

Drug

bupivacaine

Primary outcomes

  1. 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

  1. Post-operative pain scores

    Time frame: 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.

  2. Time of first analgesia request.

    Time frame: 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.

  3. Incidence of adverse events

    Time frame: 24 hours postoperatively

    Complication related to the block or adverse events of the administered drugs.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2023
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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