Clinical trial NCT01604694: Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty
Official title: Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abdominoplasty
Transversus Abdominis Plane (TAP) Block
Keywords: Abdominoplasty
Transversus Abdominis Plane (TAP) Block
levobupivacaine
Placebo
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2012-05-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opioid consumption during 24 hours after the surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Quality of analgesia
timeFrame: Until 48 hours after surgery
measure: Early rehabilitation : hour of first rising, six-minute walk test at 3days and at discharge
timeFrame: Until discharge, up to 8 days after surgery
measure: Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area
timeFrame: 15 days and 3 month after surgery
measure: Health - related quality of life preoperative and at 3 months post operatively
timeFrame: Just before and 3 months after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Centre François-Xavier Michelet
Study officials:
affiliation: USMR, University Hospital Bordeaux
name: Antoine BENARD, MD
role: STUDY_CHAIR
References: