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

Sponsor
University of Liege (Other)
Overall Status
Recruiting
CT.gov ID
NCT01862354
Collaborator
(none)
50
1
2
102
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transverse abdominal plan block
  • Procedure: Continuous wound infusion
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparative Analgesic Effect Between Continuous Wound Infusion and Transverse Abdominal Plan Block for Abdominoplasty Surgery
Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Piritramide consumption on Patient Controlled Analgesia (PCA) device [at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively]

    2. 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

    3. 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

    4. 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

    5. Number of patients with adverse events [daily during 48 hours postoperatively]

    Other Outcome Measures

    1. Total of peroperative propofol consumption (mg) [at the end of the anesthesia (average time around 180 minutes)]

    2. Total of peroperative remifentanil consumption (mg) [at the end of the anesthesia (average time around 180 minutes)]

    3. Volume of peroperative liquid infiltrated (ml) [at the end of the surgery (average time around 150 minutes)]

    4. Volume of peroperative liquid suctioned (ml) [at the end of the surgery (average time around 150 minutes)]

    5. Weight of skin resection (mg) [At the end of the surgery (average time around 150 minutes)]

    6. Volume of surgical drainage (ml) [at day 1 and day 2]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Liege, University Hospital Liege Belgium 4000

    Sponsors and Collaborators

    • University of Liege

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    J P Lecoq, MD, University of Liege
    ClinicalTrials.gov Identifier:
    NCT01862354
    Other Study ID Numbers:
    • 2013-00017214-14 2013/9
    • 2013-000172-14
    First Posted:
    May 24, 2013
    Last Update Posted:
    Apr 28, 2021
    Last Verified:
    Apr 1, 2021

    Study Results

    No Results Posted as of Apr 28, 2021