Laparoscopic Guided Transversus Abdominis Plane Block for Postoperative Analgesia After Pediatric Laparoscopic Surgery.

NCT03388671 | Unknown Phase 2 DMC

• 1 other identifier: 17300080
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas block blockade. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• FLACC PAIN score

  postoperative FLACC pain scores.

  36hours

Study Arms (2)

TAB Block

ACTIVE COMPARATOR

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Transversus abdominis plane block.

Procedure: TAB Block; Drug: Bupivacaine

Psoas Block

ACTIVE COMPARATOR

Patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided psoas block.

Procedure: Psoas Block; Drug: Bupivacaine

Interventions

TAB Block PROCEDURE

patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block

TAB Block

Psoas Block PROCEDURE

patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block

Psoas Block

Bupivacaine DRUG

patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block or TAB block

Also known as: Bucain

Psoas Block; TAB Block

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children (1-6 years) of both sexes undergoing elective laparoscopic surgeries that last \>30minutes (eg. undescended testis and inguinal hernia repair).
• Written consent, free and informed

You may not qualify if:

• Significant respiratory, cardiac or renal disease
• BMI \>95th percentile for age.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Pediatric hospital, faculty of medicine, Assiut university

Asyut, Assiut Governorate, 715715, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dental Occlusion; Bupivacaine; bucain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Hala S Abdelghaffar, MD

  Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hala S Abdelghaffar, MD

CONTACT

01003812011; hallasaad@yahoo.com

Seham M Moeen, MD

CONTACT

01006386324; seham.moeen@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The data collection personnel and the patients' guardians will be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: The aim of this study will be to investigate the safety and analgesic efficacy of Transversus Abdominis Plane (TAB) Block versus psoas blocks. Both blocks will be administered surgically and guided by the laparoscopy screen in children undergoing laparoscopic surgery.

Study Record Dates

• First Submitted: December 25, 2017
• First Posted: January 3, 2018
• Study Start: December 25, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)