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

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01604694
First received: May 15, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Abdominoplasty
Transversus Abdominis Plane (TAP) Block
Procedure: TAP Block
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Opioid consumption during 24 hours after the surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of analgesia [ Time Frame: Until 48 hours after surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: Until discharge, up to 8 days after surgery ] [ Designated as safety issue: No ]
  • Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area [ Time Frame: 15 days and 3 month after surgery ] [ Designated as safety issue: No ]
  • Health - related quality of life preoperative and at 3 months post operatively [ Time Frame: Just before and 3 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 52
Study Start Date: June 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAP Block with levobupivacaïne Procedure: 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.
Placebo Comparator: TAP Block with Placebo Procedure: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01604694

Contacts
Contact: Amelie LASSERRE, MD amelie.lasserre@chu-bordeaux.fr

Locations
France
CHU de Bordeaux, Centre François-Xavier Michelet Recruiting
Bordeaux, France, 33076
Contact: Amelie LASSERRE, MD       amelie.lasserre@chu-bordeaux.fr   
Principal Investigator: Amelie LASSERRE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Antoine BENARD, MD USMR, University Hospital Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01604694     History of Changes
Other Study ID Numbers: CHUBX 2011/10
Study First Received: May 15, 2012
Last Updated: November 7, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Abdominoplasty
Transversus Abdominis Plane (TAP) Block
levobupivacaine
Placebo

Additional relevant MeSH terms:
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014