AzTrials
AzTrials

Pain ManagementNCT04269460

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

A study testing Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] in people with Pain Management and Pediatrics, run by Kasr El Aini Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 3 months to 5 years
Conditions the study is for
Pain Management, Pediatrics, Anesthesia
What is being tested?
Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteEgypt
Study dates
1 Feb 2020to 1 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasralainy

    Cairo, 11559

Other trials in Egypt

About this study

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

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.

Read the 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.

Patient positioning and preparation for the block:

For the (sTAP) group (n=39): 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 placed obliquely on the upper abdominal wall, along the surgical site subcostal margin near the midline. After identifying the rectus abdominis muscle, we will gradually move the ultrasound probe laterally along the subcostal margin until we identify the transversus abdominis muscle lying posterior to the rectus muscle. A 22 G echogenic needle using the in-plane technique will be inserted medially near the xiphoid process aiming towards the iliac crest, 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.

For the (QLB) group (n=39): 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 between the iliac crest and the costal margin at the level of the anterior axillary line to identify the three thin parallel muscles of the anterolateral abdominal wall. The probe will be moved posteriorly following the narrowing of the muscles until the muscle fibers of transversus abdominis muscles taper off into its aponeurosis at the level of the posterior axillary line where the quadratus lumborum muscle is identified. The posterior aspect of the QL muscle is confirmed and a 22 G echogenic needle will be inserted using an in-plane technique from anterolateral to posteromedial towards this posterior aspect of the QL muscle. 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.

Vital signs (heart rate (HR) and non-invasive blood pressure) will be recorded at the onset of the block then every 15 minutes intraoperatively, and every 4 hours postoperatively for a period of 24 hours. Fentanyl 0.5 µg /kg as rescue analgesia will be given intraoperatively if HR and or systolic BP increased >20% of baseline up to maximum 5 µg/ kg.

After skin closure, inhalational anesthesia will be discontinued and reversal of muscle relaxation with atropine (0.02 mg/Kg) and neostigmine (0.05 mg/Kg) will be administered IV after return of patient's spontaneous breathing. Patients will then be transferred to post anesthesia care unit (PACU) for 60 min to complete recovery and monitoring.

Postoperative assessment and analgesic regimen:

The Face, Legs, Activity, Cry, Consolability scale (FLACC) (table 1) will be assessed immediately postoperative in the PACU and every 4 hours in the ward for 24 hours. The time to the first request of rescue postoperative analgesic will be: "the time interval between the local anesthesia injection and the first request to postoperative analgesia (patients first complain of pain and or FLACC score ≥4)". an intravenous paracetamol 15mg/kg will be given immediately postoperative and will be repeated every 6 hours. Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.05-0.1mg/kg to maintain resting FLACC scale ˂ 4 (maximum dose 0.3mg/kg). Cumulative 24 hours analgesic consumption will be recorded.

Being tested
Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]
Keywords
ultrasound, quadratus lumborum, subcostal TAP, pediatrics, pyeloplasty
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04269460
Study groupRoleWhat they receive
subcostal transversus abdominis plane block (sTAP)Active comparatorpatients 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.
Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]
quadratus lumborum block (QLB)Active comparatorpatients 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.
Receives: Drug: Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 hours

Secondary outcomes (3)
  1. • Time to first request of postoperative rescue analgesics

    the time interval between the local anesthesia injection and the first request to postoperative analgesia (patients first complain of pain and or FLACC score ≥4.

    Measured: 24 hours

  2. • Total consumption of opioids

    Measured: 24 hours

  3. • Block performance time

    time from probe contact with skin till needle withdrawal.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2020
  2. Study start1 Feb 2020
  3. Primary completion1 Mar 2021
  4. Study completion1 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04269460
Sponsor's protocol ID
D-41-2019
Status last verified
Mar 2021
First submitted
11 Feb 2020
Last updated
16 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE] in people with Pain Management and Pediatrics, run by Kasr El Aini Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale at 12 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in