NCT01862354

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2013

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

8.5 years

First QC Date

May 2, 2013

Last Update Submit

April 26, 2021

Conditions

Surgery of Abdominoplasty With Flank Liposuction

Keywords

Postoperative analgesiaAbdominoplastyContinuous wound infusionTransverse abdominal plan blockLocal anesthetics : RopivacaineRegional anesthesia

Outcome Measures

Primary Outcomes (1)

  • Pain score expressed on a visual analogue scale

    at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively

Secondary Outcomes (5)

  • 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 sedation

    at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively

  • Scale of patient's satisfaction

    at day 2 postoperatively

  • Number of patients with adverse events

    daily during 48 hours postoperatively

Other Outcomes (6)

  • 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)

  • +3 more other outcomes

Study Arms (2)

Group TAP block

ACTIVE COMPARATOR

Patients in this group received a transverse abdominal plan block with local anesthetics and clonidine as postoperative analgesia.

Procedure: Transverse abdominal plan block

Group : Continuous wound infusion

ACTIVE COMPARATOR

Patients in this group received continuous wound infusion with local anesthetics and clonidine as postoperative analgesia.

Procedure: Continuous wound infusion

Interventions

Transverse abdominal plan blockPROCEDURE

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

Also known as: Regional anesthesia : TAP block
Group TAP block
Continuous wound infusionPROCEDURE

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.

Also known as: Regional anesthesia : Continuous wound infusion
Group : Continuous wound infusion

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for abdominoplasty combined with flank liposuction

You may not qualify if:

  • Allergy to local anesthetics or clonidine
  • Coagulation disorders
  • History of chronic pain
  • Alcohol or drugs dependance
  • Refusal of the patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Liege, University Hospital

Liège, 4000, Belgium

RECRUITING

Study Officials

  • Jean-Pierre H Lecoq, Md, PhD

    University of Liege, University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Pierre H Lecoq, MD, PhD

CONTACT

003243667180jplecoq@chu.ulg.ac.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 2, 2013

First Posted

May 24, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations

BE(1)