Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
Randomized, Controlled, Double Blind Trial of Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
1 other identifier
interventional
90
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedApril 19, 2018
April 1, 2018
4 months
April 11, 2018
April 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
every hour for the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.
Secondary Outcomes (1)
Total amount of post operative morphine (mg).
any time in the first 24 post operative hours.
Other Outcomes (1)
Patient satisfaction.
every hour in the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.
Study Arms (2)
QL group
EXPERIMENTALAnterior 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.
C group
NO INTERVENTIONPatients 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.
Interventions
Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle.
Eligibility Criteria
You may qualify if:
- American society of anesthesiologists physical status \|-\|\|\| , scheduled to undergo unilateral hip replacement via lateral approach.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria faculty of medicine
Alexandria, 21519, Egypt
Related Publications (2)
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.
PMID: 28154824BACKGROUNDSauter 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.
PMID: 26426575RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Registeral
Study Record Dates
First Submitted
April 11, 2018
First Posted
April 18, 2018
Study Start
September 1, 2018
Primary Completion
January 1, 2019
Study Completion
March 1, 2019
Last Updated
April 19, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available within 6 months of study completion.
De identified individual participant data for all primary and secondary outcome measures will be made available.