Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

Phase 4

Completed

• Conditions: Abdominoplasty; Transversus Abdominis Plane (TAP) Block
• Interventions: Procedure: TAP Block

• Registration Number: NCT01604694
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-23
• Study First Posted: 2012-05-24
• Study Start: 2012-06
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP Block with levobupivacaïne	TAP Block	-
TAP Block with Placebo	TAP Block	-

Primary Outcome Measures

Name	Time	Method
Opioid consumption during 24 hours after the surgery	24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Bordeaux, Centre François-Xavier Michelet; 🇫🇷 Bordeaux, France