AbdominoplastyPhase 4TAPlastieNCT01604694
Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty
A Phase 4 study testing TAP Block in people with Abdominoplasty and Transversus Abdominis Plane (TAP) Block, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominoplasty, Transversus Abdominis Plane (TAP) Block
- What is being tested?
- TAP Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Oct 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA1 or 2 patients
- Undergoing abdominoplasty surgery in Centre François Xavier Michelet at Bordeaux University hospital
- Age >18 years old
- Patient agreement by signing an informed consent
Who cannot join
- Psychiatric or neurological disease
- Contraindication to regional anesthesia (haemostatic disorders, infection near to insertion point)
- Double surgery
- Long term opioid therapy
- Pregnancy or breast-feeding
- Allergy to any drug used in anesthesic or surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo
Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance.
The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in post operative period of abdominoplasty.
Read the detailed description
To determine if TAP block have an analgesic effect in post operative period of abdominoplasty this study was made versus placebo: one group of patients will have a TAP block of levobupivacaine, the second group will have a TAP block with placebo before the surgery. Patient follow up includes data collected before surgery (at pré anesthesic visit and just before surgery) and data collected immediately after surgery (at post operative time) and at distance of the surgery (15 days and 3 months after the surgery). The principal aim is to show if TAP block have an analgesic effect in post operative period after abdominoplasty. To answer this question we will compare opioid intake during the two days after the surgery between the two groups.
- Being tested
- TAP Block
- Keywords
- Abdominoplasty, Transversus Abdominis Plane (TAP) Block, levobupivacaine, Placebo
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP BlockProcedure or surgery
An Ultra Sound-guided TAP block is performed after induction of general anesthesia prior to surgical incision. The syringes containing either saline 20 ml (placebo group) or levobupivacaine 20 ml are prepared by the hospital pharmacy under aseptic conditions.
| Study group | Role | What they receive |
|---|---|---|
| TAP Block with levobupivacaïne | Experimental | Not described Receives: Procedure: TAP Block |
| TAP Block with Placebo | Placebo comparator | Not described Receives: Procedure: TAP Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption during 24 hours after the surgery
Measured: 24 hours after surgery
Secondary outcomes (4)
Quality of analgesia
Evaluated by opioid consumption, visual scale assessment of pain by patient, occurrence of specific adverse events (nausea, vomiting, somnolence, pruritus...)
Measured: Until 48 hours after surgery
Early rehabilitation : hour of first rising, six-minute walk test at 3days and at discharge
Measured: Until discharge, up to 8 days after surgery
Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area
Measured: 15 days and 3 month after surgery
Health - related quality of life preoperative and at 3 months post operatively
Measured: Just before and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BENARD, MD, Study chair, USMR, University Hospital Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01604694
- Sponsor's protocol ID
- CHUBX 2011/10
- Other IDs
- 2011-006003-35
- Acronym
- TAPlastie
- Status last verified
- May 2014
- First submitted
- 15 May 2012
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Transversus Abdominis Plane Block for Analgesia After Abdominoplasty: Randomized- Controlled- Trial Double Blind Monocentric Study, Against Placebo
- ClinicalTrials.gov ID
- NCT01604694
- Acronym / sponsor ID
- TAPlastie / CHUBX 2011/10
- Keywords
- Abdominoplasty, Transversus Abdominis Plane (TAP) Block, levobupivacaine, Placebo
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 May 2012 (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.
Abdominoplasty is a major cosmetic surgery with a painful post operative period. Recently more and more anaesthetists are turning to regional analgesia for anterior abdominal wall surgery namely the Transversus Abdominis Plane (TAP) Block with or without ultrasound guidance.
The aim of this study is to evaluate the analgesic effect of TAP block ultrasound guided in post operative period of abdominoplasty.
Detailed description
To determine if TAP block have an analgesic effect in post operative period of abdominoplasty this study was made versus placebo: one group of patients will have a TAP block of levobupivacaine, the second group will have a TAP block with placebo before the surgery. Patient follow up includes data collected before surgery (at pré anesthesic visit and just before surgery) and data collected immediately after surgery (at post operative time) and at distance of the surgery (15 days and 3 months after the surgery). The principal aim is to show if TAP block have an analgesic effect in post operative period after abdominoplasty. To answer this question we will compare opioid intake during the two days after the surgery between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP Block with levobupivacaïne | Experimental | Procedure: TAP Block |
| TAP Block with Placebo | Placebo comparator | Procedure: TAP Block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA1 or 2 patients
- Undergoing abdominoplasty surgery in Centre François Xavier Michelet at Bordeaux University hospital
- Age >18 years old
- Patient agreement by signing an informed consent
Key exclusion criteria (6 listed)
- Psychiatric or neurological disease
- Contraindication to regional anesthesia (haemostatic disorders, infection near to insertion point)
- Double surgery
- Long term opioid therapy
- Pregnancy or breast-feeding
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 |
|---|---|---|
| TAP BlockAn Ultra Sound-guided TAP block is performed after induction of general anesthesia prior to surgical incision. The syringes containing either saline 20 ml (placebo group) or levobupivacaine 20 ml are prepared by the hospital pharmacy under aseptic conditions. | Procedure or surgery | TAP Block with Placebo, TAP Block with levobupivacaïne |
Primary outcome
Opioid consumption during 24 hours after the surgery
Time frame: 24 hours after surgery
4 secondary outcomes
Quality of analgesia
Time frame: Until 48 hours after surgery
Early rehabilitation : hour of first rising, six-minute walk test at 3days and at discharge
Time frame: Until discharge, up to 8 days after surgery
Evaluation of Neuropathic pain, pain thresholds, hyperalgesia area
Time frame: 15 days and 3 month after surgery
Health - related quality of life preoperative and at 3 months post operatively
Time frame: Just before and 3 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
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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.
Antoine BENARD, MD study chair
USMR, University Hospital Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TAP Block in people with Abdominoplasty and Transversus Abdominis Plane (TAP) Block, run by University Hospital, Bordeaux at 1 site in France.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 28 May 2026. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid consumption during 24 hours after the surgery (time frame: 24 hours after surgery). 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 May 2026.