Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery (QLB)
Primary Purpose
Quadratus Lumborum Block, Abdominoplasty, Analgesia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QLB anesthesia
Intravenous anesthesia without QLB
Sponsored by
About this trial
This is an interventional treatment trial for Quadratus Lumborum Block focused on measuring Quadratus lumborum block, Abdominoplasty, Analgesia, Locoregional Anesthesia
Eligibility Criteria
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.
Sites / Locations
- BARRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
QLB technique
Intravenous anesthesia without QLB
Arm Description
Outcomes
Primary Outcome Measures
Variation from baseline of morphine consumption
Secondary Outcome Measures
Variation from baseline of morphine consumption
Variation from baseline of morphine consumption
Variation from baseline of morphine consumption
Full Information
NCT ID
NCT04670224
First Posted
December 1, 2020
Last Updated
February 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT04670224
Brief Title
Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery
Acronym
QLB
Official Title
Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadratus Lumborum Block, Abdominoplasty, Analgesia, Locoregional Anesthesia
Keywords
Quadratus lumborum block, Abdominoplasty, Analgesia, Locoregional Anesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
286 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QLB technique
Arm Type
Experimental
Arm Title
Intravenous anesthesia without QLB
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
QLB anesthesia
Intervention Description
The QLB is a bilateral locoregional anesthesia technique, performed after surgery, under general anesthesia and in right and then left lateral decubitus.
Intervention Type
Other
Intervention Name(s)
Intravenous anesthesia without QLB
Intervention Description
only intravenous anesthesia
Primary Outcome Measure Information:
Title
Variation from baseline of morphine consumption
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Variation from baseline of morphine consumption
Time Frame
1 hour after surgery
Title
Variation from baseline of morphine consumption
Time Frame
2 hours after surgery
Title
Variation from baseline of morphine consumption
Time Frame
48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ottilie FUMERY- TROCHERIS, MD
Phone
(33)3 22 08 78 36
Email
fumery.ottilie@chu-amiens.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane BAR, MD
Email
bar.stephane@chu-amiens.fr
Facility Information:
Facility Name
BAR
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane Bar, Dr
Phone
(33)322088371
Email
bar.stephane@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Nizar ASSAF, MD
First Name & Middle Initial & Last Name & Degree
Florent LEVIEL, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficiency of the Quadratus Lumborum Block for Post-operative Analgesia in Abdominoplasty Surgery
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