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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04670224
Other study ID # PI2020_843_0094
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 16, 2021
Est. completion date January 2024

Study information

Verified date February 2023
Source Centre Hospitalier Universitaire, Amiens
Contact Ottilie FUMERY- TROCHERIS, MD
Phone (33)3 22 08 78 36
Email fumery.ottilie@chu-amiens.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 286
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
QLB anesthesia
The QLB is a bilateral locoregional anesthesia technique, performed after surgery, under general anesthesia and in right and then left lateral decubitus.
Intravenous anesthesia without QLB
only intravenous anesthesia

Locations

Country Name City State
France BAR Amiens

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Variation from baseline of morphine consumption 24 hours after surgery
Secondary Variation from baseline of morphine consumption 1 hour after surgery
Secondary Variation from baseline of morphine consumption 2 hours after surgery
Secondary Variation from baseline of morphine consumption 48 hours after surgery
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