Clinical trial NCT01862354: Analgesic Effect Between TAP Block and Continuous Wound Infusion in Abdominoplasty Surgery
Official title: Comparative Analgesic Effect Between Continuous Wound Infusion and Transverse Abdominal Plan Block for Abdominoplasty Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery of Abdominoplasty With Flank Liposuction
Keywords: Postoperative analgesia
Abdominoplasty
Continuous wound infusion
Transverse abdominal plan block
Local anesthetics : Ropivacaine
Regional anesthesia
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2013-05-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pain score expressed on a visual analogue scale
timeFrame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Secondary outcomes:
measure: Piritramide consumption on Patient Controlled Analgesia (PCA) device
timeFrame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
measure: Scale of nausea
timeFrame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
measure: Scale of sedation
timeFrame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
measure: Scale of patient's satisfaction
timeFrame: at day 2 postoperatively
measure: Number of patients with adverse events
timeFrame: daily during 48 hours postoperatively
Other outcomes:
measure: Total of peroperative propofol consumption (mg)
timeFrame: at the end of the anesthesia (average time around 180 minutes)
measure: Total of peroperative remifentanil consumption (mg)
timeFrame: at the end of the anesthesia (average time around 180 minutes)
measure: Volume of peroperative liquid infiltrated (ml)
timeFrame: at the end of the surgery (average time around 150 minutes)
measure: Volume of peroperative liquid suctioned (ml)
timeFrame: at the end of the surgery (average time around 150 minutes)
measure: Weight of skin resection (mg)
timeFrame: At the end of the surgery (average time around 150 minutes)
measure: Volume of surgical drainage (ml)
timeFrame: at day 1 and day 2
Locations:
city: Liege
country: Belgium
facility: University of Liege, University Hospital
Study officials:
affiliation: University of Liege, University Hospital
name: Jean-Pierre H Lecoq, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References: