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Analgesia in Total Hip Arthroplasty by Quadratus Lumborum Block (ATHAQLuB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03666260
Recruitment Status : Unknown
Verified September 2018 by CHU de Reims.
Recruitment status was:  Recruiting
First Posted : September 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Total Hip Replacement Surgery Procedure: Quadratus Lumborum Block Procedure: femoral block Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Clinical Effectiveness of the Quadratus Lumborum Block and Femoral Block in the Analgesia of Total Posterior Hip Arthroplasty
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : October 8, 2020
Estimated Study Completion Date : April 8, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Quadratus Lumborum Block arm Procedure: Quadratus Lumborum Block
Quadratus Lumborum Block with echography
Active Comparator: Femoral block arm Procedure: femoral block
femoral block with echography


Outcome Measures
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Primary Outcome Measures :
  1. morphine consumption [ Time Frame: 24 hours ]
    Morphine consumption during the 24 hours postoperative


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03666260


Contacts
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Contact: Olivier FERNANDES 03 10 73 61 68 0fernandes@chu-reims.fr
Contact: Armelle DE BAENE 03 10 73 66 70 adebaene@chu-reims.fr

Locations
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France
Damien JOLLY Recruiting
Reims, France
Contact: Olivier FERNANDES    03 10 73 61 68    ofernandes@chu-reims.fr   
Sponsors and Collaborators
CHU de Reims
More Information
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Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03666260    
Other Study ID Numbers: PO18122
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CHU de Reims:
Total hip replacement surgery
post operative pain
quadratus lumborum block
femoral block