NCT04670224

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 16, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4.7 years

First QC Date

December 1, 2020

Last Update Submit

May 23, 2025

Conditions

Keywords

Quadratus lumborum blockAbdominoplastyAnalgesiaLocoregional Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Variation from baseline of morphine consumption

    24 hours after surgery

Secondary Outcomes (3)

  • Variation from baseline of morphine consumption

    1 hour after surgery

  • Variation from baseline of morphine consumption

    2 hours after surgery

  • Variation from baseline of morphine consumption

    48 hours after surgery

Study Arms (2)

QLB technique

EXPERIMENTAL
Other: QLB anesthesia

Intravenous anesthesia without QLB

ACTIVE COMPARATOR
Other: Intravenous anesthesia without QLB

Interventions

The QLB is a bilateral locoregional anesthesia technique, performed after surgery, under general anesthesia and in right and then left lateral decubitus.

QLB technique

only intravenous anesthesia

Intravenous anesthesia without QLB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients admitted for programmed dermo-lipectomy surgery with or without associated liposuction.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BAR

Amiens, 80054, France

Location

MeSH Terms

Conditions

Agnosia

Interventions

Anesthesia, Intravenous

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2020

First Posted

December 17, 2020

Study Start

March 16, 2021

Primary Completion

December 1, 2025

Study Completion

January 1, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations