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

Not Applicable

• Conditions: Surgery of Abdominoplasty With Flank Liposuction
• Interventions: Procedure: Transverse abdominal plan block; Procedure: Continuous wound infusion

• Registration Number: NCT01862354
• Lead Sponsor: University of Liege

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).

Study Timeline

• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-24
• Study Start: 2013-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group TAP block	Transverse abdominal plan block	Patients in this group received a transverse abdominal plan block with local anesthetics and clonidine as postoperative analgesia.
Group : Continuous wound infusion	Continuous wound infusion	Patients in this group received continuous wound infusion with local anesthetics and clonidine as postoperative analgesia.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 nausea was defined as : 0 = No nausea - 1 = weak nausea - 2 = Moderate nausea - 3 = Important nausea
Scale of sedation	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
Scale of patient's satisfaction	at day 2 postoperatively	Scale of satisfaction was defined as : 1 = Very satisfied - 2 = Satisfied with no enthusiasm - 3 = Not satisfied
Number of patients with adverse events	daily during 48 hours postoperatively

Trial Locations

Locations (1)

University of Liege, University Hospital; 🇧🇪 Liege, Belgium