Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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To determine if TAP block have an analgesic effect in post operative period of abdominoplasty this study was made versus placebo: one group of patients will have a TAP block of levobupivacaine, the second group will have a TAP block with placebo before the surgery. Patient follow up includes data collected before surgery (at pré anesthesic visit and just before surgery) and data collected immediately after surgery (at post operative time) and at distance of the surgery (15 days and 3 months after the surgery). The principal aim is to show if TAP block have an analgesic effect in post operative period after abdominoplasty. To answer this question we will compare opioid intake during the two days after the surgery between the two groups.

Official Title
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Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo

Conditions
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Abdominoplasty, Transversus Abdominis Plane (TAP) Block

Intervention / Treatment
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* Procedure: TAP Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP Block with levobupivacaïne<br> | Procedure: TAP Block<br>* 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.<br>|
| Placebo Comparator: TAP Block with Placebo<br> | Procedure: TAP Block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption during 24 hours after the surgery |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of analgesia | Evaluated by opioid consumption, visual scale assessment of pain by patient, occurrence of specific adverse events (nausea, vomiting, somnolence, pruritus...) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominoplasty, Transversus Abdominis Plane (TAP) Block, levobupivacaine, Placebo