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

NCT ID: NCT06098105

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2024-04-21

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Ultrasound-guided transversus abdominis plane block

Intervention Type 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.

Bupivacaine

Intervention Type DRUG

bupivacaine

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.

Group Type EXPERIMENTAL

Laparoscopic-assisted transversus abdominis plane block

Intervention Type 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.

Bupivacaine

Intervention Type DRUG

bupivacaine

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.

Group Type EXPERIMENTAL

Laparoscopic-assisted intraperitoneal instillation

Intervention Type 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

Intervention Type DRUG

bupivacaine

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Bupivacaine

bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

2 Months

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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ِAhmed Mohamed Ibrahim

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tanta University

Tanta, El-Gharbia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR352/9/23

Identifier Type: -

Identifier Source: org_study_id

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