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

Ultrasound Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06098105
• Other study ID #: 36264PR352/9/23
• Status: Completed
• Phase: N/A
• Start date: October 24, 2023
• Est. completion date: April 21, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: April 21, 2024
• Est. primary completion date: April 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Months to 7 Years

Eligibility

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).

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia Repair
• Laparoscopic
• Pediatrics
• Transversus Abdominis Plane Block
• Ultrasound

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total postoperative pethidine consumption	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.	24 hours postoperatively
Secondary	Post-operative pain scores	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.	24 hours postoperatively
Secondary	Time of first analgesia request.	Time of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia.	24 hours postoperatively
Secondary	Incidence of adverse events	Complication related to the block or adverse events of the administered drugs.	24 hours postoperatively