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Clinical Trials/NCT01862354
NCT01862354
Unknown
Not Applicable

Comparative Analgesic Effect Between Continuous Wound Infusion and Transverse Abdominal Plan Block for Abdominoplasty Surgery

University of Liege1 site in 1 country50 target enrollmentJune 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgery of Abdominoplasty With Flank Liposuction
Sponsor
University of Liege
Enrollment
50
Locations
1
Primary Endpoint
Pain score expressed on a visual analogue scale
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this randomized controlled study is to compare the postoperative analgesic effect of a continuous wound infusion of local anesthetics and a sole transverse abdominal plan (TAP) regional block in the surgery of Abdominoplasty Combined With Flank Liposuction. Local anesthetics products used are ropivacaine combined with clonidine. Similar amount of local anesthetics and clonidine are used.

Detailed Description

In a first group, patients receive, after induction of anaesthesia and before surgery, a TAP block (transverse abdominal plan block) with 3mg/kg Ropivacaine 0.5% (maximum 200 mg) and 150 microg Clonidine. In a second group, before skin closure, a multiholes catheter was inserted beyond the skin. 20 mg Ropivacaine 0.2% added with 150 microg Clonidine was injected as bolus dose through this catheter followed by a continuous infusion of Ropivacaine 0.2% 10ml per hour during the following 9 hours (total dose of 200 mgr).

Registry
clinicaltrials.gov
Start Date
June 2013
End Date
December 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

J P Lecoq

MD

University of Liege

Eligibility Criteria

Inclusion Criteria

  • Patients scheduled for abdominoplasty combined with flank liposuction

Exclusion Criteria

  • Allergy to local anesthetics or clonidine
  • Coagulation disorders
  • History of chronic pain
  • Alcohol or drugs dependance
  • Refusal of the patients

Outcomes

Primary Outcomes

Pain score expressed on a visual analogue scale

Time Frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively

Secondary Outcomes

  • Piritramide consumption on Patient Controlled Analgesia (PCA) device(at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively)
  • Scale of nausea(at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively)
  • Scale of sedation(at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively)
  • Scale of patient's satisfaction(at day 2 postoperatively)
  • Number of patients with adverse events(daily during 48 hours postoperatively)

Study Sites (1)

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