Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Abdominoplasty
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Opioid consumption during 24 hours after the surgery
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Opioid consumption during 24 hours after the surgery
Time Frame: 24 hours after surgery
Secondary Outcomes
- 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)