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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Surgery of Abdominoplasty With Flank Liposuction

Intervention / Treatment
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* Procedure: Transverse abdominal plan block
* Procedure: Continuous wound infusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group TAP block<br>Patients in this group received a transverse abdominal plan block with local anesthetics and clonidine as postoperative analgesia. | Procedure: Transverse abdominal plan block<br>* 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<br>* Other names: Regional anesthesia : TAP block;|
| Active Comparator: Group : Continuous wound infusion<br>Patients in this group received continuous wound infusion with local anesthetics and clonidine as postoperative analgesia. | Procedure: Continuous wound infusion<br>* 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.<br>* Other names: Regional anesthesia : Continuous wound infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative analgesia, Abdominoplasty, Continuous wound infusion, Transverse abdominal plan block, Local anesthetics : Ropivacaine, Regional anesthesia