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Clinical Trials/NCT04269460
NCT04269460CompletedNot Applicable

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

Kasr El Aini Hospital1 site in 1 country78 target enrollmentStarted: February 1, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
78
Locations
1
Primary Endpoint
Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale at 12 hours

Study Overview

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.

Detailed Description

This randomized, controlled study is designed to:

  • Assess the quality of perioperative analgesia (intraoperative hemodynamics, postoperative pain score and analgesic consumption) provided by ultrasound guided subcostal TAP and quadratus lumborum blocks in pediatrics undergoing pyeloplasty surgeries.
  • Compare the efficacy and safety of both blocks in pediatrics undergoing pyeloplasty surgery.

Hypothesis

Following approval from research and ethics committee of anesthesia department, Faculty of Medicine, Cairo University, children will be pre-medicated by intramuscular injection of atropine 0.02 mg/Kg, midazolam 0.2 mg/Kg and ketamine 2 mg/ Kg before admission to operation theater (OR).

Upon arrival to OR; continuous electrocardiography (ECG), pulse oximetry, non-invasive arterial blood pressure will be applied and baseline readings will be recorded, then general anesthesia will be induced by 8% sevoflurane and 50% air in oxygen. Peripheral venous cannula will be inserted after loss of consciousness. If a patient had an intravenous (IV) cannula, induction will be performed using 1.5-2.5 mg/kg propofol, in both situations atracurium at a dose of 0.5 mg/kg will be given intravenously to facilitate endotracheal intubation and fentanyl at a dose 2 µg/kg will be given to abolish stress response of intubation. Anesthesia will be maintained by using 1-1.5% isoflurane in a mixture of oxygen and air (50/50) and atracurium top ups at a dose of 0.1mg/kg every 30 minutes.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
3 Months to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] (Drug)

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.

Intervention: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 24 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.

Secondary Outcomes

  • • Total consumption of opioids(24 hours)
  • • Block performance time(24 hours)
  • • Time to first request of postoperative rescue analgesics(24 hours)

Investigators

Sponsor
Kasr El Aini Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Khaled Abdelfattah Abdallah Sarhan

lecturer of anesthesia, Cairo university hospitals

Kasr El Aini Hospital

Study Sites (1)

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