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

Primary Purpose

Laparoscopic, Ultrasound, Transversus Abdominis Plane Block

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound-guided transversus abdominis plane block
Laparoscopic-assisted transversus abdominis plane block
Laparoscopic-assisted intraperitoneal instillation
Bupivacaine
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic

Eligibility Criteria

2 Months - 7 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Ultrasound-guided transversus abdominis plane block

Laparoscopic-assisted transversus abdominis plane block

Laparoscopic-assisted intraperitoneal instillation

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 19, 2023
Last Updated
October 24, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT06098105
Brief Title
Laparoscopic vs Ultrasound-Guided Transversus Abdominis Plane Block vs Laparoscopic Intraperitoneal Instillation of Local Anesthetic in Pediatrics
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 24, 2023 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic, Ultrasound, Transversus Abdominis Plane Block, Laparoscopic Intraperitoneal Instillation, Pediatrics, Inguinal Hernia Repair

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Laparoscopic-assisted transversus abdominis plane block
Arm Type
Experimental
Arm Description
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.
Arm Title
Laparoscopic-assisted intraperitoneal instillation
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Ultrasound-guided transversus abdominis plane block
Intervention Description
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
Intervention Name(s)
Laparoscopic-assisted transversus abdominis plane block
Intervention Description
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
Intervention Name(s)
Laparoscopic-assisted intraperitoneal instillation
Intervention Description
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
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
bupivacaine
Primary Outcome Measure Information:
Title
Total postoperative pethidine consumption
Description
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.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Post-operative pain scores
Description
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.
Time Frame
24 hours postoperatively
Title
Time of first analgesia request.
Description
Time of first analgesic requirement, which represent the time elapsed from the end of the surgery till the first request of rescue analgesia.
Time Frame
24 hours postoperatively
Title
Incidence of adverse events
Description
Complication related to the block or adverse events of the administered drugs.
Time Frame
24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed M Ibrahim, MD
Phone
00201141779238
Email
ahmed.edib@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed M Ibrahim, MD
Phone
00201141779238
Email
ahmed.edib@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed A Elhaddad, MD
First Name & Middle Initial & Last Name & Degree
Osama M Rehab, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.

Learn more about this trial

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

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