- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03666260
Analgesia in Total Hip Arthroplasty by Quadratus Lumborum Block (ATHAQLuB)
Comparison of the Clinical Effectiveness of the Quadratus Lumborum Block and Femoral Block in the Analgesia of Total Posterior Hip Arthroplasty
Patients are painful after total hip arthroplasty. These patients have significant co-morbidities. Analgesics cause significant side effects in this population. Locoregional analgesia is therefore an effective means of reducing the consumption of opioids in this surgery.
The "gold standard" of locoregional analgesia after Total Hip Arthroplasty is the femoral block. However, a new technique has recently been described: the Quadratus Lumborum Block.
The comparison of these two techniques is lacking in the literature. The comparison of the Quadratus Lumborum Block to the femoral block in Total Hip arthroplasty is important in the analgesic strategy of patients undergoing this surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to compare the clinical efficacy of two regional locoregional analgesia strategies in total hip replacement surgery: the ultrasound-guided Quadratus Lumborum Block and the ultrasound-guided femoral block.
This is a double-blind, randomized study in prospective inclusion with a superiority test. Two groups of patients will be compared: a group of patients with a quadratus lumborum block and a group of patients with a femoral block.
Management (quadratus lumborum block or femoral block) will be randomized. The randomization will be stratified on the type of anesthesia (spinal anesthesia and general anesthesia). Randomization will be done on the day of surgery to determine the patient's treatment group. The surgical procedure will not be modified by the participation of the patent in the study.
Patients who would benefit from total hip replacement surgery in the Reims University Hospital and who agreed to participate in the study were included.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Olivier FERNANDES
- Phone Number: 03 10 73 61 68
- Email: 0fernandes@chu-reims.fr
Study Contact Backup
- Name: Armelle DE BAENE
- Phone Number: 03 10 73 66 70
- Email: adebaene@chu-reims.fr
Study Locations
-
-
-
Reims, France
- Recruiting
- Damien JOLLY
-
Contact:
- Olivier FERNANDES
- Phone Number: 03 10 73 61 68
- Email: ofernandes@chu-reims.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients eligible for total hip replacement surgery in Reims University Hospital
- Patients agreeing to participate in the research and having signed informed consent
- between 18 yo and 95 yo
- Patients affiliated to a social security system
Exclusion Criteria:
- Patients with allergy to local anesthetics
- Patients with neuropathy
- Patients with an ASA score of 4
- Patients undergoing revision surgery for total hip arthroplasty
- Patients receiving anterior hip total hip replacement surgery
- Patients with a contraindication to the realization of the quadratus lumborum block, femoral block or spinal anesthesia (clinical coagulopathy, infection at the point of puncture ...)
- Patients refusing the proposed techniques
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Quadratus Lumborum Block arm
|
Quadratus Lumborum Block with echography
|
Active Comparator: Femoral block arm
|
femoral block with echography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
morphine consumption
Time Frame: 24 hours
|
Morphine consumption during the 24 hours postoperative
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PO18122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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