Quadratus Lumborum Block Versus Caudal Block for Pediatric Postoperative Analgesia

NCT03646630 | Completed

• 1 other identifier: D141
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare between two regional analgesic techniques; caudal block and ultrasound guided quadratus lumborum block as regard degree of pain relief, accuracy of block, effect on hemodynamic stability and incidence of complications.

Conditions

Pain, Postoperative

Keywords

lower abdominal surgeries; quadratus lumborum block; caudal block

Outcome Measures

Primary Outcomes (1)

• Time at which the first analgesia required

  in hours

  24 hours after procedure

Secondary Outcomes (23)

• Pain assessment by the aid of FLACC score

  30 minutes after operation

• Pain assessment by the aid of FLACC score

  1 hour after operation

• Pain assessment by the aid of FLACC score

  2 hours after operation

• Pain assessment by the aid of FLACC score

  4 hours after operation

• Pain assessment by the aid of FLACC score

  6 hours after operation

Study Arms (2)

Quadratus Lumborum Block (QL)

ACTIVE COMPARATOR

Patients will be placed in the lateral position,The high-frequency linear probe will be placed on the lateral abdomen, slightly cephalic to the iliac crest. Once the QL muscle will be observed, the probe will be tilted slightly to the caudal direction, to show the largest slice of the QL muscle, to confirm its posterior aspect. A 22-G block needle (Stimuplex D, Braun, Hongo, Bunkyo-ku, and Tokyo) will be inserted in-plane, \~1 cm ventral to the probe. The needle tip will be advanced until it penetrates the posterior fascia of the QL muscle. A small amount of saline will be injected to confirm the correct position of the tip, between the QL muscle and the erector spinae and latissimus dorsi muscles (Posterior or QL block type 2), then a bolus of 0.5 ml/Kg bupivacaine 0.25% will be injected.

Procedure: Quadratus Lumborum Block

Caudal block (C)

ACTIVE COMPARATOR

After induction of general anesthesia, a lateral position is obtained with the upper hip flexed 90⁰ and the lower one only 45⁰. A line is drawn to connect the posterior superior iliac spines bilaterally and used as one side of an equilateral triangle; then the location of the sacral hiatus should be approximated. By palpating the sacral cornua as 2 bony prominences, the sacral hiatus could be identified as a dimple in between. A 22 gauge needle is inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone is contacted. Children will receive caudal block with 1 ml/kg of bupivacaine 0.25%.

Procedure: Caudal Block

Interventions

Quadratus Lumborum Block PROCEDURE

Posterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25%

Quadratus Lumborum Block (QL)

Caudal Block PROCEDURE

caudal block with 1 ml/kg of bupivacaine 0.25%.

Caudal block (C)

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 1-7 years
• American Society of Anesthesiologists physical status I-II
• Lower abdominal surgery

You may not qualify if:

• History of developmental delay or mental retardation
• Parent refusal
• History of allergic reactions to local anesthetics
• Rash or infection at the injection site
• Anatomical abnormality
• Bleeding disorders.
• History of cardiac, neurological, renal, hepatic diseases.

Sponsors & Collaborators

• Fayoum University Hospital: lead
• Cairo University: collaborator

Study Sites (1)

Fayoum University hospital

El Fayoum Qesm, Faiyum Governorate, 63514, Egypt

Location

Related Publications (5)

• Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.

  PMID: 11460814 BACKGROUND

• Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.

  PMID: 22630613 BACKGROUND

• Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090.

  PMID: 25642956 BACKGROUND

• Liu SS, Ngeow J, John RS. Evidence basis for ultrasound-guided block characteristics: onset, quality, and duration. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S26-35. doi: 10.1097/AAP.0b013e3181d266f0.

  PMID: 20216022 BACKGROUND

• Griffin J, Nicholls B. Ultrasound in regional anaesthesia. Anaesthesia. 2010 Apr;65 Suppl 1:1-12. doi: 10.1111/j.1365-2044.2009.06200.x.

  PMID: 20377542 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Kareem M Nawwar, MD

  Kasr ElAini Hospital, Faculty Of Medicine, Cairo Univerisity

  STUDY DIRECTOR

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: Assistant Lecturer of Anesthesiology

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 24, 2018
• Study Start: May 2, 2019
• Primary Completion: August 1, 2020
• Study Completion: October 15, 2020
• Last Updated: September 7, 2022

Record last verified: 2022-09

Locations

EG (1)