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NCT Number: NCT01604694

Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

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.

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Key information

Conditions

Abdominoplasty Bites and Stings Chemically-Induced Disorders Poisoning Transversus Abdominis Plane (TAP) Block Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CHU de Bordeaux, Centre François-Xavier Michelet

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TAP Block

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.

Primary outcomes

  1. Opioid consumption during 24 hours after the surgery

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Quality of analgesia

    Time frame: 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...)

  2. 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

  3. Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area

    Time frame: 15 days and 3 month after surgery

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

    Time frame: Just before and 3 months after surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: TAPlastie

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 24, 2012
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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