Ultrasound Guided Subcostal Transversus Abdominis Plane Block Versus Quadratus Lumborum Block for Pediatrics Undergoing Pyeloplasty.

NCT04269460 | Completed

• 1 other identifier: D-41-2019
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this work to compare the analgesic efficacy of preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block in pediatric patients undergoing pyeloplasty surgeries.

Conditions

Pain Management; Pediatrics; Anesthesia

Keywords

ultrasound; quadratus lumborum; subcostal TAP; pediatrics; pyeloplasty

Outcome Measures

Primary Outcomes (1)

• Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale at 12 hours

  The FLACC scale or Face, Legs, Activity, Cry, Consolability scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain. The scale has five criteria, which are each assigned a score of 0, 1 or 2.

  24 hours

Secondary Outcomes (3)

• • Time to first request of postoperative rescue analgesics

  24 hours

• • Total consumption of opioids

  24 hours

• • Block performance time

  24 hours

Study Arms (2)

subcostal transversus abdominis plane block (sTAP)

ACTIVE COMPARATOR

patients will be in the supine position; after preparing the skin with with povidone iodine, a high frequency (5-10 MHz) ultrasound probe will be used tp identify the rectus abdominis muscle, then 1 mL/Kg of bupivacaine 0.25% will be injected in the plane between rectus abdominis and transversus abdominis muscles.The patient will then be positioned for the procedure if other than supine position is chosen.

Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]

quadratus lumborum block (QLB)

ACTIVE COMPARATOR

patients will be positioned in the lateral decubitus position so that the blocked side will be the uppermost one. After skin sterilization with povidone iodine the ultrasound probe will be positioned to identify the quadratus lumborum muscle. then 1 mL/Kg of bupivacaine 0.25% will be injected behind the QL muscle on the lateral border of the erector spinae muscle.The patient will then be positioned for the procedure if other than lateral decubitus position is chosen.

Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]

Interventions

Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] DRUG

preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block using 1 ml/kg of Bupivacaine Hydrochloride 0.25%in pediatric patients undergoing pyeloplasty surgeries.

quadratus lumborum block (QLB); subcostal transversus abdominis plane block (sTAP)

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesia (ASA) physical status I-II.
• Age: 3 months to 5 years.
• Undergoing pyeloplasty surgeries.

You may not qualify if:

• Refusal of parents.
• Patients with coagulation disorders (INR \> 1.5 and/or platelets \< 100 000).
• History of allergic reactions to local anesthetics.
• Rash or signs of infection at the injection site.
• Emergency surgery.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasralainy

Cairo, 11559, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia, Cairo university hospitals

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 13, 2020
• Study Start: February 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Locations

EG (1)