Abdominoplasty, Transversus Abdominis Plane (TAP) Block
Conditions
Keywords
Abdominoplasty, Transversus Abdominis Plane (TAP) Block, levobupivacaine, Placebo
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.
Interventions
PROCEDURETAP Block
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.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Opioid consumption during 24 hours after the surgery | 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of analgesia | Until 48 hours after surgery | Evaluated by opioid consumption, visual scale assessment of pain by patient, occurrence of specific adverse events (nausea, vomiting, somnolence, pruritus...) |
| 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 | — |
Countries
France
Contacts
STUDY_CHAIRAntoine BENARD, MD
USMR, University Hospital Bordeaux
Outcome results
None listed