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Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Anterior Quadratus lamborum block
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American society of anesthesiologists physical status |-||| , scheduled to undergo unilateral hip replacement via lateral approach.

Exclusion Criteria:

  • patient refusal.
  • History of neurological/neuromuscular, psychiatric, dementia preventing proper comprehension.
  • coagulation disorders.
  • History of allergy to the study medication.
  • Infection overlying the injection site.

Sites / Locations

  • Alexandria faculty of medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

QL group

C group

Arm Description

Anterior Quadratus lumborum block will be done for all patients of these group. Local anaesthetic (30ml of bupivacaine) will be injected in fascial plane between the quadratus lumborum muscle and Psoas major muscle by using the ultrasound.

Patients of these group will be the control group. The will receive acetaminophen 1g every 8h, ketorolac 30mg ever 12h and as required morphine 2mg for post operative analgesia after hip arthroplasty.

Outcomes

Primary Outcome Measures

Pain intensity assessment
Patients will be trained to use visual analogue scale which consists of 10cm line, 0 cm equivalent to no pain and 10 cm denoting the worst imaginable pain.

Secondary Outcome Measures

Total amount of post operative morphine (mg).
Total amount of post operative morphine (mg) used as rescue analgesia and the first time of its request.

Full Information

First Posted
April 11, 2018
Last Updated
April 17, 2018
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT03502369
Brief Title
Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
Official Title
Randomized, Controlled, Double Blind Trial of Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2018 (Anticipated)
Primary Completion Date
January 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria 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
The study evaluates the effectiveness of anterior quadratus lumborum block for post operative analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will not receive the block ( control group).
Detailed Description
Sensory innervation of the hip region involves branches of the lumbar plexus and sacral plexus. Effective post operative analgesia can be approached by blocking the lumbar plexus at the level of the quadratus lumborum muscle. Quadratus lumborum block has several approach methods (anterior, lateral, posterior, and intramuscular). Anterior quadratus lumborum block also known as transmuscular QL block or QL3, the local anaesthetic (30ml of bupivacaine 0.375%) is injected between the psoas major muscle (PM) and the quadratus lumborum muscle (QL). Therefore, the anterior quadratus lumborum block may generate analgesia from T10 to L4 covering the sensory innervation of the hip region.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Adult 90 orthopaedic patient ASA physical status |-||| will be randomly allocated in two groups each one 45 patients, one group will receive the anterior quadratus lumborum block and the other group will not receive the block.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QL group
Arm Type
Experimental
Arm Description
Anterior Quadratus lumborum block will be done for all patients of these group. Local anaesthetic (30ml of bupivacaine) will be injected in fascial plane between the quadratus lumborum muscle and Psoas major muscle by using the ultrasound.
Arm Title
C group
Arm Type
No Intervention
Arm Description
Patients of these group will be the control group. The will receive acetaminophen 1g every 8h, ketorolac 30mg ever 12h and as required morphine 2mg for post operative analgesia after hip arthroplasty.
Intervention Type
Procedure
Intervention Name(s)
Anterior Quadratus lamborum block
Other Intervention Name(s)
Transmuscular QL block, QL3
Intervention Description
Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle.
Primary Outcome Measure Information:
Title
Pain intensity assessment
Description
Patients will be trained to use visual analogue scale which consists of 10cm line, 0 cm equivalent to no pain and 10 cm denoting the worst imaginable pain.
Time Frame
every hour for the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.
Secondary Outcome Measure Information:
Title
Total amount of post operative morphine (mg).
Description
Total amount of post operative morphine (mg) used as rescue analgesia and the first time of its request.
Time Frame
any time in the first 24 post operative hours.
Other Pre-specified Outcome Measures:
Title
Patient satisfaction.
Description
Patient satisfaction with pain control will be assessed on a four point scale 1.Excellent 2.Good 3.fair 4.poor
Time Frame
every hour in the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American society of anesthesiologists physical status |-||| , scheduled to undergo unilateral hip replacement via lateral approach. Exclusion Criteria: patient refusal. History of neurological/neuromuscular, psychiatric, dementia preventing proper comprehension. coagulation disorders. History of allergy to the study medication. Infection overlying the injection site.
Facility Information:
Facility Name
Alexandria faculty of medicine
City
Alexandria
ZIP/Postal Code
21519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
moutaz Ghandour, professor
Phone
01003363712
Email
moutaz.ghandour@alexmed.edu.eg
First Name & Middle Initial & Last Name & Degree
Abdullah Gaber, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
Citations:
PubMed Identifier
28154824
Citation
Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.
Results Reference
background
PubMed Identifier
26426575
Citation
Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.
Results Reference
result

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Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty

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