Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty

Abdominoplasty Clinical Trial

— TAPlastie  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604694
• Other study ID #: CHUBX 2011/10
• Status: Completed
• Phase: Phase 4
• First received: May 15, 2012
• Last updated: May 9, 2014
• Start date: June 2012
• Est. completion date: October 2013

Study information

• Verified date: May 2014
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominoplasty
• Transversus Abdominis Plane (TAP) Block

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Bordeaux, Centre François-Xavier Michelet	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption during 24 hours after the surgery		24 hours after surgery	No
Secondary	Quality of analgesia	Evaluated by opioid consumption, visual scale assessment of pain by patient, occurrence of specific adverse events (nausea, vomiting, somnolence, pruritus...)	Until 48 hours after surgery	No
Secondary	Early rehabilitation : hour of first rising, six-minute walk test at 3days and at discharge		Until discharge, up to 8 days after surgery	No
Secondary	Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area		15 days and 3 month after surgery	No
Secondary	Health - related quality of life preoperative and at 3 months post operatively		Just before and 3 months after surgery	No