Clinical Trials Directory

Trials / Completed

CompletedNCT01604694

Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

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

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
52 (actual)
Sponsor
University Hospital, Bordeaux · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURETAP BlockAn 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.

Timeline

Start date
2012-06-01
Primary completion
2013-07-01
Completion
2013-10-01
First posted
2012-05-24
Last updated
2014-05-12

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01604694. Inclusion in this directory is not an endorsement.