Surgery of Abdominoplasty With Flank LiposuctionNCT01862354
Analgesic Effect Between TAP Block and Continuous Wound Infusion in Abdominoplasty Surgery
A study testing Transverse abdominal plan block and Continuous wound infusion in people with Surgery of Abdominoplasty With Flank Liposuction, run by University of Liege at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Surgery of Abdominoplasty With Flank Liposuction
- What is being tested?
- Transverse abdominal plan block and Continuous wound infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2013to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for abdominoplasty combined with flank liposuction
Who cannot join
- Allergy to local anesthetics or clonidine
- Coagulation disorders
- History of chronic pain
- Alcohol or drugs dependance
- Refusal of the patients
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Liege, University Hospital
Liège, 4000
Jean-Pierre H Lecoq, MD, PhD, 003243667180, jplecoq@chu.ulg.ac.be
Jean-François Brichant, Md, PhD, 003243667180, anesrea@ulg.ac.be
About this study
Official title: Comparative Analgesic Effect Between Continuous Wound Infusion and Transverse Abdominal Plan Block for Abdominoplasty Surgery
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.
Read the 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).
- Being tested
- Transverse abdominal plan block, Continuous wound infusion
- Keywords
- Postoperative analgesia, Abdominoplasty, Continuous wound infusion, Transverse abdominal plan block, Local anesthetics : Ropivacaine, Regional anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transverse abdominal plan blockProcedure or surgery
Also called Regional anesthesia : TAP 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
Continuous wound infusionProcedure or surgery
Also called Regional anesthesia : 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.
| Study group | Role | What they receive |
|---|---|---|
| Group TAP block | Active comparator | Patients in this group received a transverse abdominal plan block with local anesthetics and clonidine as postoperative analgesia. Receives: 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. Receives: Procedure: Continuous wound infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score expressed on a visual analogue scale
Measured: 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
Measured: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of nausea
Scale of nausea was defined as :
0 = No nausea - 1 = weak nausea - 2 = Moderate nausea - 3 = Important nausea
Measured: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of sedation
Scale of sedation was defined as :
0 = Awake patient - 1 = Quiet and awake - 2 = Sleepy but arousable - 3 = Sleepy and not arousable
Measured: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of patient's satisfaction
Scale of satisfaction was defined as :
1 = Very satisfied - 2 = Satisfied with no enthusiasm - 3 = Not satisfied
Measured: at day 2 postoperatively
Number of patients with adverse events
Measured: daily during 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery of Abdominoplasty With Flank LiposuctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J P Lecoq, University of Liege
- Investigators
- Jean-Pierre H Lecoq, Md, PhD, Principal investigator, University of Liege, University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862354
- Sponsor's protocol ID
- 2013-00017214-14 2013/9
- Other IDs
- 2013-000172-14
- Status last verified
- Apr 2021
- First submitted
- 2 May 2013
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Analgesic Effect Between Continuous Wound Infusion and Transverse Abdominal Plan Block for Abdominoplasty Surgery
- ClinicalTrials.gov ID
- NCT01862354
- Acronym / sponsor ID
- 2013-00017214-14 2013/9
- Keywords
- Postoperative analgesia, Abdominoplasty, Continuous wound infusion, Transverse abdominal plan block, Local anesthetics : Ropivacaine, Regional anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group TAP block | Active comparator | Procedure: Transverse abdominal plan blockPatients in this group received a transverse abdominal plan block with local anesthetics and clonidine as postoperative analgesia. |
| Group : Continuous wound infusion | Active comparator | Procedure: Continuous wound infusionPatients in this group received continuous wound infusion with local anesthetics and clonidine as postoperative analgesia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for abdominoplasty combined with flank liposuction
Key exclusion criteria (5 listed)
- Allergy to local anesthetics or clonidine
- Coagulation disorders
- History of chronic pain
- Alcohol or drugs dependance
- Refusal of the patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transverse abdominal plan blockAlso: Regional anesthesia : TAP blockTransverse 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 | Procedure or surgery | Group TAP block |
| Continuous wound infusionAlso: Regional anesthesia : Continuous wound infusionIn 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. | Procedure or surgery | Group : Continuous wound infusion |
Primary outcome
Pain score expressed on a visual analogue scale
Time frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
5 secondary outcomes
Piritramide consumption on Patient Controlled Analgesia (PCA) device
Time frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of nausea
Time frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of sedation
Time frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively
Scale of patient's satisfaction
Time frame: at day 2 postoperatively
Number of patients with adverse events
Time frame: daily during 48 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre H Lecoq, Md, PhD principal investigator
University of Liege, University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transverse abdominal plan block and Continuous wound infusion in people with Surgery of Abdominoplasty With Flank Liposuction, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Pierre H Lecoq, MD, PhD (003243667180, jplecoq@chu.ulg.ac.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score expressed on a visual analogue scale (time frame: at 0,2,4,6, 8 hours, and day 1 and day 2 postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.