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

NCT04963816 | Completed DMC

• 1 other identifier: 34737/6/21
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Post Operative Pain; Quadratus Lumborum Block; Pediatric; Abdominal Surgery

Keywords

Quadratus lumborum block in pediatrics; Dexamethasone

Outcome Measures

Primary Outcomes (2)

• 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.

  24 hours

• The duration of analgesia

  the time starting from extubation until analgesia will be required as evidenced by a pain score \> 4.

  24 hours

Secondary Outcomes (2)

• The total amount of paracetamol doses

  24 hours

• Postoperative vomiting

  12 hours

Study Arms (3)

Group A Quadratus Lumborum Block with dexamethasone IV

ACTIVE COMPARATOR

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

Procedure: ultrasound guided quadratus lumborum block; Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously; Drug: Bupivacaine Injection

Group B Quadratus Lumborum Block with dexamethasone locally

ACTIVE COMPARATOR

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

Procedure: ultrasound guided quadratus lumborum block; Drug: Bupivacaine Injection; Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally

Group C Quadratus Lumborum Block with bupivacaine alone

PLACEBO COMPARATOR

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

Procedure: ultrasound guided quadratus lumborum block; Drug: Bupivacaine Injection

Interventions

ultrasound guided quadratus lumborum block PROCEDURE

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

Group A Quadratus Lumborum Block with dexamethasone IV; Group B Quadratus Lumborum Block with dexamethasone locally; Group C Quadratus Lumborum Block with bupivacaine alone

Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously DRUG

Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A

Also known as: Dexamethasone as an adjuvant intravenously

Group A Quadratus Lumborum Block with dexamethasone IV

Bupivacaine Injection DRUG

Bupivacaine will be given to all groups locally with QLB

Also known as: Light marcaine

Group A Quadratus Lumborum Block with dexamethasone IV; Group B Quadratus Lumborum Block with dexamethasone locally; Group C Quadratus Lumborum Block with bupivacaine alone

Dexamethasone Phosphate 4 MG/ML Injectable Solution locally DRUG

Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B

Also known as: Dexamethasone as an adjuvant locally

Group B Quadratus Lumborum Block with dexamethasone locally

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Algharbia, 0000, Egypt

Location

Related Publications (1)

• Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.

  PMID: 36288584 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexamethasone 21-phosphate; Dexamethasone; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• AHMED A SHAMA, MD

  Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine

  PRINCIPAL INVESTIGATOR

• SHERIF K ARAFA, MD

  ASSISTANT PROFESSOR of anesthesia and surgical ICU

  STUDY CHAIR

• AMIR A EL SAYED, MD

  ASSISTANT PROFESSOR of anesthesia and surgical ICU

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer and consultant of anesthesia and surgical ICU

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 15, 2021
• Study Start: June 16, 2021
• Primary Completion: October 30, 2021
• Study Completion: January 10, 2022
• Last Updated: February 3, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)