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

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: Surgery of Abdominoplasty With Flank Liposuction
• Intervention / Treatment: Procedure: Transverse abdominal plan block; Procedure: Continuous wound infusion

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

• Study Contact: Name: Jean-Pierre H Lecoq, MD, PhD; Phone Number: 003243667180; Email: jplecoq@chu.ulg.ac.be

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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		at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of nausea	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	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	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		daily during 48 hours postoperatively

Other Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Postoperative analgesia; Abdominoplasty; Regional anesthesia; Continuous wound infusion; Transverse abdominal plan block; Local anesthetics : Ropivacaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2013-00017214-14 2013/9; 2013-000172-14 (EudraCT Number)