Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

University Hospital, Bordeaux52 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Abdominoplasty Transversus Abdominis Plane (TAP) Block

Interventions

TAP BlockPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

CHU de Bordeaux, Centre François-Xavier Michelet

Bordeaux, France

Outcomes

Primary Outcomes

Opioid consumption during 24 hours after the surgery

Time frame: 24 hours after surgery

Secondary Outcomes

Quality of analgesia

Evaluated by opioid consumption, visual scale assessment of pain by patient, occurrence of specific adverse events (nausea, vomiting, somnolence, pruritus...)

Time frame: Until 48 hours after surgery

Early rehabilitation : hour of first rising, six-minute walk test at 3days and at discharge

Time frame: Until discharge, up to 8 days after surgery

Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area

Time frame: 15 days and 3 month after surgery

Health - related quality of life preoperative and at 3 months post operatively

Time frame: Just before and 3 months after surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.