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Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine. (QLB)

Primary Purpose

Post Operative Pain, Quadratus Lumborum Block, Pediatric

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ultrasound guided quadratus lumborum block
Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously
Bupivacaine Injection
Dexamethasone Phosphate 4 MG/ML Injectable Solution locally
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring Quadratus lumborum block in pediatrics, Dexamethasone

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pediatric patients(6-12 years)
  • ASA physical status I,II
  • Abdominal surgery

Exclusion Criteria:

  • Parents refusal or legal guardian's refusal
  • Allergy to bupivacaine or dexamethasone
  • Contraindications to regional techniques
  • Failed QLB
  • Infection on site of procedure

Sites / Locations

  • Tanta University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group A Quadratus Lumborum Block with dexamethasone IV

Group B Quadratus Lumborum Block with dexamethasone locally

Group C Quadratus Lumborum Block with bupivacaine alone

Arm Description

QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline

QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline

Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline.

Outcomes

Primary Outcome Measures

Postoperative analgesia
using the Pediatric Objective Pain Scale (15), where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia.
The duration of analgesia
the time starting from extubation until analgesia will be required as evidenced by a pain score > 4.

Secondary Outcome Measures

The total amount of paracetamol doses
paracetamol doses (15 mg/kg per dose) as a rescue analgesic will be needed after the onset of pain
Postoperative vomiting
vomiting and/or retching without expulsion of gastric content will be recorded by a nurse who will be blinded to study conditions. It will treated if vomiting occurred more than twice in 2 minutes with by granisetron

Full Information

First Posted
June 23, 2021
Last Updated
February 2, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04963816
Brief Title
Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine.
Acronym
QLB
Official Title
Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
January 10, 2022 (Actual)

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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries
Detailed Description
After obtaining written informed consent from parents or guardians of all patients, 90 patients (6-12 years old) scheduled for abdominal surgeries operations will be included. Patients will be randomly allocated into three groups, 30 patients in each group. Randomization will be based on computer-generated codes maintained in sequentially numbered opaque envelopes. Anesthetic Technique: Anesthesia will be induced with Sevoflurane plus fentanyl (0.5µg/kg) and tracheal intubation will be facilitated with Rocuronium (0.4 mg/kg). Anesthesia will be maintained with Sevoflurane (will be adjusted according to A line autoregressive index (AAI)) and Rocuronium (0.1 mg/kg/dose will be given on the basis of train-of-four neuromuscular monitoring). ECG, noninvasive blood pressure, heart rate, temperature, oxygen saturation, and exhaled CO2 (end tidal CO2) will be continuously monitored during the procedure. • After induction of anesthesia and before skin incision, a QLB will be performed in all patients in the three groups. The procedure will be done under ultrasound guidance using curved array transducer 5-2MHz (Sonosite ultrasound system). Echogenic needle, Sono Plex Stim cannula (PAJUNK) 22 gauge and 60 mm length will be used. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The QLB block will be performed by anterior approach. The linear probe will be attached in the area of the triangle of Petit in transverse orientation in lateral abdomen in between the iliac crest and the costal margin, near the posterior axillary line. The muscle planes will be identified until visualizing the quadratus lumborum muscle, at the same plane as the psoas major muscle and the erector spinae. The needle tip is placed at the anterolateral border of the QL at its junction of QL with transversalis fascia outside the anterior layer of the thoracolumbar fascia (TLF) and fascia transversalis, and the local anesthetic will be injected. Anesthesia will be discontinued when the wound dressing applied, and muscle relaxant will be reversed using (50ug/kg) of neostigmine and atropine (0.02mg/kg) and extubating of the patient will be done. The patient will be transferred to the postoperative care unit (POCU).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Quadratus Lumborum Block, Pediatric, Abdominal Surgery
Keywords
Quadratus lumborum block in pediatrics, Dexamethasone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A Quadratus Lumborum Block with dexamethasone IV
Arm Type
Active Comparator
Arm Description
QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline
Arm Title
Group B Quadratus Lumborum Block with dexamethasone locally
Arm Type
Active Comparator
Arm Description
QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline
Arm Title
Group C Quadratus Lumborum Block with bupivacaine alone
Arm Type
Placebo Comparator
Arm Description
Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline.
Intervention Type
Procedure
Intervention Name(s)
ultrasound guided quadratus lumborum block
Intervention Description
Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously
Other Intervention Name(s)
Dexamethasone as an adjuvant intravenously
Intervention Description
Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Other Intervention Name(s)
Light marcaine
Intervention Description
Bupivacaine will be given to all groups locally with QLB
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Phosphate 4 MG/ML Injectable Solution locally
Other Intervention Name(s)
Dexamethasone as an adjuvant locally
Intervention Description
Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B
Primary Outcome Measure Information:
Title
Postoperative analgesia
Description
using the Pediatric Objective Pain Scale (15), where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia.
Time Frame
24 hours
Title
The duration of analgesia
Description
the time starting from extubation until analgesia will be required as evidenced by a pain score > 4.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The total amount of paracetamol doses
Description
paracetamol doses (15 mg/kg per dose) as a rescue analgesic will be needed after the onset of pain
Time Frame
24 hours
Title
Postoperative vomiting
Description
vomiting and/or retching without expulsion of gastric content will be recorded by a nurse who will be blinded to study conditions. It will treated if vomiting occurred more than twice in 2 minutes with by granisetron
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pediatric patients(6-12 years) ASA physical status I,II Abdominal surgery Exclusion Criteria: Parents refusal or legal guardian's refusal Allergy to bupivacaine or dexamethasone Contraindications to regional techniques Failed QLB Infection on site of procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED A SHAMA, MD
Organizational Affiliation
Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
SHERIF K ARAFA, MD
Organizational Affiliation
ASSISTANT PROFESSOR of anesthesia and surgical ICU
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
AMIR A EL SAYED, MD
Organizational Affiliation
ASSISTANT PROFESSOR of anesthesia and surgical ICU
Official's Role
Study Chair
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
0000
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine.

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