Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

NCT ID: NCT01604694

Last Updated: 2014-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-10-31

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.

Conditions

Abdominoplasty; Transversus Abdominis Plane (TAP) Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

TAP Block with levobupivacaïne

Group Type: EXPERIMENTAL

TAP Block

Intervention Type: PROCEDURE

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.

TAP Block with Placebo

Group Type: PLACEBO_COMPARATOR

TAP Block

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine BENARD, MD

Role: STUDY_CHAIR

USMR, University Hospital Bordeaux

Locations

CHU de Bordeaux, Centre François-Xavier Michelet

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2011/10

Identifier Type: -

Identifier Source: org_study_id