Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty (TAPlastie)

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominoplasty; Transversus Abdominis Plane (TAP) Block
• Intervention / Treatment: Procedure: TAP Block

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux, Centre François-Xavier Michelet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP Block with levobupivacaïne	Procedure: TAP 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.
Placebo Comparator: TAP Block with Placebo	Procedure: TAP 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Antoine BENARD, MD, USMR, University Hospital Bordeaux

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 15, 2012
• First Submitted That Met QC Criteria: May 23, 2012
• First Posted (Estimated): May 24, 2012

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Placebo; Abdominoplasty; levobupivacaine; Transversus Abdominis Plane (TAP) Block
• Additional Relevant MeSH Terms: Wounds and Injuries; Chemically-Induced Disorders; Poisoning; Bites and Stings
• Other Study ID Numbers: CHUBX 2011/10; 2011-006003-35 (EudraCT Number)