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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06098105
Collaborator
(none)
66
1
3
5.3
12.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Ultrasound-guided transversus abdominis plane block
  • Procedure: Laparoscopic-assisted transversus abdominis plane block
  • Procedure: Laparoscopic-assisted intraperitoneal instillation
  • Drug: Bupivacaine
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
Oct 24, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Procedure: 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.

Drug: Bupivacaine
bupivacaine

Experimental: 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.

Procedure: 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.

Drug: Bupivacaine
bupivacaine

Experimental: 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.

Procedure: 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.

Drug: Bupivacaine
bupivacaine

Outcome Measures

Primary Outcome Measures

  1. Total postoperative pethidine consumption [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 Outcome Measures

  1. Post-operative pain scores [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. [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 [24 hours postoperatively]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months to 7 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Tanta El-Gharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ِAhmed Mohamed Ibrahim, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT06098105
Other Study ID Numbers:
  • 36264PR352/9/23
First Posted:
Oct 24, 2023
Last Update Posted:
Oct 25, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 25, 2023