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

University Hospital of Bordeaux

Status and phase: Completed; Phase 4

Conditions: Transversus Abdominis Plane (TAP) Block; Abdominoplasty

Treatments: Procedure: TAP Block

Study type: Interventional

Funder types: Other

Identifiers

NCT01604694

CHUBX 2011/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

TAP Block with levobupivacaïne

Experimental group

Treatment:

Procedure: TAP Block

TAP Block with Placebo

Placebo Comparator group

Treatment:

Procedure: TAP Block