Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty
TAPlastie
1 other identifier
interventional
52
1 country
1
Brief Summary
Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance. The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in post operative period of abdominoplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2012
CompletedFirst Posted
Study publicly available on registry
May 24, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedMay 12, 2014
May 1, 2014
1.1 years
May 15, 2012
May 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Opioid consumption during 24 hours after the surgery
24 hours after surgery
Secondary Outcomes (4)
Quality of analgesia
Until 48 hours after surgery
Early rehabilitation : hour of first rising, six-minute walk test at 3days and at discharge
Until discharge, up to 8 days after surgery
Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area
15 days and 3 month after surgery
Health - related quality of life preoperative and at 3 months post operatively
Just before and 3 months after surgery
Study Arms (2)
TAP Block with levobupivacaïne
EXPERIMENTALTAP Block with Placebo
PLACEBO COMPARATORInterventions
An Ultra Sound-guided TAP block is performed after induction of general anesthesia prior to surgical incision. The syringes containing either saline 20 ml (placebo group) or levobupivacaine 20 ml are prepared by the hospital pharmacy under aseptic conditions.
Eligibility Criteria
You may qualify if:
- ASA1 or 2 patients
- Undergoing abdominoplasty surgery in Centre François Xavier Michelet at Bordeaux University hospital
- Age \>18 years old
- Patient agreement by signing an informed consent
You may not qualify if:
- Psychiatric or neurological disease
- Contraindication to regional anesthesia (haemostatic disorders, infection near to insertion point)
- Double surgery
- Long term opioid therapy
- Pregnancy or breast-feeding
- Allergy to any drug used in anesthesic or surgical procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Bordeaux, Centre François-Xavier Michelet
Bordeaux, 33076, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Antoine BENARD, MD
USMR, University Hospital Bordeaux
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2012
First Posted
May 24, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2013
Study Completion
October 1, 2013
Last Updated
May 12, 2014
Record last verified: 2014-05