- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04670224
Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery (QLB)
Abdominoplasty is a common surgical procedure in plastic surgery which causes postoperative pain and may delay patients' recovery. Surgery is potentially associated with a number of postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or digestive … Although they do not inevitably lead to a life-threatening prognosis, in many cases these complications delay post-operative recovery. Defined in the 1990s by Professor Henry Kehlet's Danish team, rapid rehabilitation after planned surgery is an approach to overall patient care that aims to rapidly restore previous physical and mental capacities and thus significantly reduce mortality and morbidity. Pain management is at the heart of this program and local anesthesia techniques are at the heart of early rehabilitation programs.
Described for just over a decade, Quadratus Lumborum Block (QLB) have shown their effectiveness for analgesia in abdominal, or orthopedic, or obstetrical surgery. Considering the anatomical territory concerned, this locoregional anesthesia technique seems to be very interesting in abdominoplasty to allow early rehabilitation of the patient.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Amiens, France, 80054
- BAR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adult patients admitted for programmed dermo-lipectomy surgery with or without associated liposuction.
Exclusion Criteria:
- Pregnant woman
- Patient under 18 years of age
- Subject under guardianship or curators
- Patient allergic to local anesthetics
- Infection at the puncture sites
- Patient on morphine analgesic over the long term
- Patient on antidepressants for neuropathic pain.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: QLB technique
|
The QLB is a bilateral locoregional anesthesia technique, performed after surgery, under general anesthesia and in right and then left lateral decubitus.
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Active Comparator: Intravenous anesthesia without QLB
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only intravenous anesthesia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Variation from baseline of morphine consumption
Time Frame: 24 hours after surgery
|
24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Variation from baseline of morphine consumption
Time Frame: 1 hour after surgery
|
1 hour after surgery
|
|
Variation from baseline of morphine consumption
Time Frame: 2 hours after surgery
|
2 hours after surgery
|
|
Variation from baseline of morphine consumption
Time Frame: 48 hours after surgery
|
48 hours after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI2020_843_0094
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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