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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06098105
Enrollment
66
Registered
2023-10-24
Start date
2023-10-24
Completion date
2024-04-21
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

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.

PROCEDURELaparoscopic-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.

PROCEDURELaparoscopic-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.

DRUGBupivacaine

bupivacaine

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Months to 7 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Total postoperative pethidine consumption24 hours postoperativelyThe 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

MeasureTime frameDescription
Post-operative pain scores24 hours postoperativelyFace, 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.
Time of first analgesia request.24 hours postoperativelyTime of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia.
Incidence of adverse events24 hours postoperativelyComplication related to the block or adverse events of the administered drugs.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026