Analgesic Effect Between TAP Block and Continuous Wound Infusion in Abdominoplasty Surgery

April 26, 2021 updated by: J P Lecoq, University of Liege

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Liege, Belgium, 4000
        • Recruiting
        • University of Liege, University Hospital
        • Contact:
        • Contact:
          • Jean-François Brichant, Md, PhD
          • Phone Number: 003243667180
          • Email: anesrea@ulg.ac.be
        • Principal Investigator:
          • Jean-Pierre H Lecoq, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group TAP block
Patients in this group received a transverse abdominal plan block with local anesthetics and clonidine as postoperative analgesia.
Procedure: Transverse abdominal plan block
Transverse abdominal plan block was performed after induction of anaesthesia and before surgery. 3 mg/kg of Ropivacaine 5mg/ml (maximum 200 mg) plus 150 microg of Clonidine were injected at the good place. The was realised with the aid of ultrasound
Other Names:
  • Regional anesthesia : TAP block
Active Comparator: Group : Continuous wound infusion
Patients in this group received continuous wound infusion with local anesthetics and clonidine as postoperative analgesia.
Procedure: Continuous wound infusion
In this group, a multihole catheter was surgically inserted vertically before skin closure. The catheter was primed with Ropivacaine 2 mg/ml 10 ml plus clonidine 150 microg before the end of anaesthesia. Continuous wound infusion was started at a rate of 10 ml per hour of Ropivacaine 2 mg/ml during the first 9 hours after the surgery.
Other Names:
  • Regional anesthesia : Continuous wound infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain score expressed on a visual analogue scale
Time Frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Piritramide consumption on Patient Controlled Analgesia (PCA) device
Time Frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of nausea
Time Frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively

Scale of nausea was defined as :

0 = No nausea - 1 = weak nausea - 2 = Moderate nausea - 3 = Important nausea
at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of sedation
Time Frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively

Scale of sedation was defined as :

0 = Awake patient - 1 = Quiet and awake - 2 = Sleepy but arousable - 3 = Sleepy and not arousable
at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of patient's satisfaction
Time Frame: at day 2 postoperatively

Scale of satisfaction was defined as :

1 = Very satisfied - 2 = Satisfied with no enthusiasm - 3 = Not satisfied
at day 2 postoperatively
Number of patients with adverse events
Time Frame: daily during 48 hours postoperatively
daily during 48 hours postoperatively

Other Outcome Measures

Outcome Measure
Time Frame
Total of peroperative propofol consumption (mg)
Time Frame: at the end of the anesthesia (average time around 180 minutes)
at the end of the anesthesia (average time around 180 minutes)
Total of peroperative remifentanil consumption (mg)
Time Frame: at the end of the anesthesia (average time around 180 minutes)
at the end of the anesthesia (average time around 180 minutes)
Volume of peroperative liquid infiltrated (ml)
Time Frame: at the end of the surgery (average time around 150 minutes)
at the end of the surgery (average time around 150 minutes)
Volume of peroperative liquid suctioned (ml)
Time Frame: at the end of the surgery (average time around 150 minutes)
at the end of the surgery (average time around 150 minutes)
Weight of skin resection (mg)
Time Frame: At the end of the surgery (average time around 150 minutes)
At the end of the surgery (average time around 150 minutes)
Volume of surgical drainage (ml)
Time Frame: at day 1 and day 2
at day 1 and day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Liege

Investigators

  • Principal Investigator: Jean-Pierre H Lecoq, Md, PhD, University of Liege, University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

May 2, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 24, 2013

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013-00017214-14 2013/9
  • 2013-000172-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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