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Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty

Primary Purpose

Quadratus Lumborum Block

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Quadratus lumborum Block
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quadratus Lumborum Block

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 75 patients, aged between 21- 80 years old, of both sex American society of Anesthesiology I - III scheduled for total hip replacement surgery.

Exclusion Criteria:

  • Patient refusal.
  • Coagulopathy
  • Spinal deformities
  • Peripheral neuropathy; sensory disorders in the leg requiring surgery and chronic pain.
  • Mental dysfunction, psychiatric illnesses and cognitive dysfunction.
  • History of drug abuse &chronic analgesic use

Sites / Locations

  • Tanata university hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

Group I: Control Group

Group II:( transverse trans muscular Quadratus lumborum group).

Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK

Arm Description

Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.

patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK(30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

Outcomes

Primary Outcome Measures

Postoperative morphine consumption
Total Morphine consumption in the first 24 h of the post-operative period .

Secondary Outcome Measures

Postoperative pain score
• Postoperative pain will be assessed by VAS (score for the severity of pain in the range 0-10, where 0 = no pain and 10 = severe pain) at 2,4,6,12,18,24 hours. If the VAS is 4 or more, 3 mg of intravenous morphine will be given as a rescue analgesia.

Full Information

First Posted
July 7, 2022
Last Updated
July 23, 2022
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05465967
Brief Title
Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty
Official Title
A Comparative Study Between Two Approaches of Ultrasound-Guided Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

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

5. Study Description

Brief Summary
The aim of this study is to compare between the post-operative analgesic effect of two approaches of transmuscular quadratus lumborum block (transverse versus paraspinous sagittal transmuscular QLB) in total hip replacement surgery.
Detailed Description
During the preanesthetic assessment, all patients will be educated about the visual analogue scale (VAS) for pain assessment, with scores ranging from 0 to 10 (0 represent no pain, while10 represent maximum intolerable pain). The patients will be randomly classified into three equal groups (25 patients each). Group allocation will be done by computer generated random numbers and closed opaque sealed envelopes. The study will be designed to be double blind as all patients and postoperative assessor will be blinded to group assignment. Patients will be randomized to one of three equal groups: Group I: Control group (n= 25 patients): Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery. Group II (n= 25 patients): Patients in this group will receive an ipsilateral single shot of transverse transmuscular approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance. Group III (n= 25 patients): patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of QLB (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadratus Lumborum Block

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Group I: Control Group
Arm Type
Sham Comparator
Arm Description
Patients in this group will receive ipsilateral sham ultrasound-guided block via subcutaneous injection of 1 ml of normal saline after surgery.
Arm Title
Group II:( transverse trans muscular Quadratus lumborum group).
Arm Type
Active Comparator
Arm Description
patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK(30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Arm Title
Group III : paraspinous sagittal approach of Quadratus lumborum BLOCK
Arm Type
Active Comparator
Arm Description
patients in this group will receive an ipsilateral single-shot of paraspinous sagittal approach of Quadratus lumborum BLOCK (30 ml of plain bupivacaine 0.25%) after surgery using ultrasonographic guidance.
Intervention Type
Procedure
Intervention Name(s)
Quadratus lumborum Block
Intervention Description
1-Transverse transmuscular Quadratus lumborum block: ultrasound transducer will placed transverse to the abdominal flank to visualise abdominal muscle layers. moving the probe posteriorly, the transverse process of the lumbar vertebra, Quadratus lumborum, Psoas Major and erector spinae muscles identified as a 'Shamrock sign'. the needle will inserted through the back muscles to fascial plane between the Quadratus lumborum and Psoas Major, local anesthetic will injected .2- paraspinous sagittal Quadratus lumborum block: ultrasound transducer will be directed caudally in a sagittal plane lateral to the spinous process of L4. moving laterally until the Quadratus lumborum is evident in its long axis with a characteristic sonographic image of three muscle layers appearing from posterior to anterior as: erector spinae, Quadratus lumborum, and Psoas major muscle the needle will be advanced through the muscles, until it pierces the Quadratus lumborum. local anesthetic will be injected.
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
Total Morphine consumption in the first 24 h of the post-operative period .
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Postoperative pain score
Description
• Postoperative pain will be assessed by VAS (score for the severity of pain in the range 0-10, where 0 = no pain and 10 = severe pain) at 2,4,6,12,18,24 hours. If the VAS is 4 or more, 3 mg of intravenous morphine will be given as a rescue analgesia.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 75 patients, aged between 21- 80 years old, of both sex American society of Anesthesiology I - III scheduled for total hip replacement surgery. Exclusion Criteria: Patient refusal. Coagulopathy Spinal deformities Peripheral neuropathy; sensory disorders in the leg requiring surgery and chronic pain. Mental dysfunction, psychiatric illnesses and cognitive dysfunction. History of drug abuse &chronic analgesic use
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mai A nida, msc
Phone
+201012328193
Email
mai.nida90@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Sh Elbrol, MD
Phone
+201063345623
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YASSER M RAGHEB, PROF
Organizational Affiliation
TANYAU
Official's Role
Study Chair
Facility Information:
Facility Name
Tanata university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
20462458
Citation
Singh JA, Lewallen D. Predictors of pain and use of pain medications following primary Total Hip Arthroplasty (THA): 5,707 THAs at 2-years and 3,289 THAs at 5-years. BMC Musculoskelet Disord. 2010 May 13;11:90. doi: 10.1186/1471-2474-11-90.
Results Reference
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PubMed Identifier
33437078
Citation
Abduallah MA, Ahmed SA, Abdelghany MS. The effect of post-operative ultrasound-guided transmuscular quadratus lumborum block on post-operative analgesia after hip arthroplasty in elderly patients: A randomised controlled double-blind study. Indian J Anaesth. 2020 Oct;64(10):887-893. doi: 10.4103/ija.IJA_275_20. Epub 2020 Oct 1.
Results Reference
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Transmuscular Quadratus Lumborum Block on Post-Operative Analgesia After Total Hip Arthroplasty

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