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

NCT ID: NCT01862354

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2021-12-31

Brief Summary

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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

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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).

Conditions

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Surgery of Abdominoplasty With Flank Liposuction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group TAP block

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

Group Type ACTIVE_COMPARATOR

Transverse abdominal plan block

Intervention Type PROCEDURE

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

Group : Continuous wound infusion

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

Group Type ACTIVE_COMPARATOR

Continuous wound infusion

Intervention Type PROCEDURE

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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Regional anesthesia : TAP block Regional anesthesia : Continuous wound infusion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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J P Lecoq

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Pierre H Lecoq, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Liege, University Hospital

Locations

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University of Liege, University Hospital

Liège, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Jean-Pierre H Lecoq, MD, PhD

Role: CONTACT

003243667180

Facility Contacts

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Jean-Pierre H Lecoq, MD, PhD

Role: primary

003243667180

Jean-François Brichant, Md, PhD

Role: backup

003243667180

Other Identifiers

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2013-000172-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2013-00017214-14 2013/9

Identifier Type: -

Identifier Source: org_study_id

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