Surgery of Abdominoplasty With Flank Liposuction
Conditions
Keywords
Postoperative analgesia, Abdominoplasty, Continuous wound infusion, Transverse abdominal plan block, Local anesthetics : Ropivacaine, Regional anesthesia
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).
Interventions
PROCEDURETransverse 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
PROCEDUREContinuous 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.
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Other
| 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 |
Countries
Belgium
Contacts
Primary ContactJean-Pierre H Lecoq, MD, PhD
Outcome results
None listed