Post Operative PainPhase 4TAPANCT01278264
Transversus Abdominis Plane Blocks With Abdominoplasty
A Phase 4 study testing Ropivacaine 0.25%, 0.5 ml/kg in people with Post Operative Pain, run by Clinique Saint-Jean, Bruxelles at 1 site in Belgium.
Trial summary
Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Ropivacaine 0.25%, 0.5 ml/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2011to Aug 2012
- 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 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Eligible for abdominoplasty
- ASA 1-2
- Fluent french/dutch/english
Who cannot join
- History of allergy to local anaesthetics
- Chronic opioids abuse
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane Blocks in Patients Scheduled for an Abdominoplasty. A Prospective, Randomized, Double Blind, Comparison Between the Posterior Approach and Placebo.
Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty.
Read the detailed description
TAP blocks have the potential to become an important part of multi-modal analgesia after abdominal surgery (1,2). Originally Dr J McDonnell described a blind double pop technique, trough the triangle of Petit, with up to 48 hours of analgesia (3,4). Dr P Hebbard described an ultrasound based technique with a subcostal (for supra-umbilical analgesia) and an axillary mid-line injection (for sub-umbilical analgesia) in the TAP, with reported analgesia for up to 8 hours (5,6). Recently Dr J McDonnell presented data showing para vertebral spread (up to L5) of the (high dose, low concentration) local anaesthetic explaining the prolonged analgesic effect (7,8). In 2007 Dr Blanco described an ultrasound guided technique for the posterior infiltration as performed by McDonnell (9). Our limited observational comparison between both block techniques confirms this difference. We decided to compare both techniques (the ultrasound guided single shot subcostal injection, the aTAP-group (Hebbard is from Australia) and the ultrasound guided posterior injection, the iTAP-group (McDonnell is from Ireland). We will use the same volume and concentration of local anesthetic and we will asses their analgesic efficacy and improvement in quality of recovery.
- Conditions
- Post Operative Pain
- Being tested
- Ropivacaine 0.25%, 0.5 ml/kg
- Keywords
- Transversus abdominis plane block, Ultrasound guided, Abdominoplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.25%, 0.5 ml/kgDrug
Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle
Ropivacaine 0.25%, 0.5 ml/kgDrug
Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet
| Study group | Role | What they receive |
|---|---|---|
| iTAP-group | Active comparator | Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle Receives: Drug: Ropivacaine 0.25%, 0.5 ml/kg |
| aTAP-group | Active comparator | Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet Receives: Drug: Ropivacaine 0.25%, 0.5 ml/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Consumption measured by the use of the PCA pump
Measured: 48 hours
Secondary outcomes (6)
VAS score
Measured: 48 hours
Post operative nausea and vomiting
Measured: 48 hours
Constipation
Measured: 48 hours
Pruritus
Measured: 48 hours
First time to get up
Measured: 48 hours
First time to eat
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startJun 2011
- Primary completionMay 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Saint-Jean, Bruxelles
- Sponsor type
- University, hospital or other
- Investigators
- Arnaud G Bosteels, MD, Principal investigator, Clinique Saint-Jean, Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01278264
- Sponsor's protocol ID
- ANESAB001
- Acronym
- TAPA
- Status last verified
- Feb 2011
- First submitted
- 14 Jan 2011
- Last updated
- 27 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
PubMed 21154380Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
PubMed 20175754Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
PubMed 190201586. McDonnell J. XXIX Annual ESRA congress - Porto, Portugal, 2010.
7. Blanco R. TAP block under ultrasound guidance: the description of a
Griffiths JD, Barron FA, Grant S, Bjorksten AR, Hebbard P, Royse CF. Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. Br J Anaesth. 2010 Dec;105(6):853-6. doi: 10.1093/bja/aeq255. Epub 2010 Sep 22.
PubMed 20861094Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
PubMed 211486515. McDonnell J. Ultrasound guided abdominal wall blocks. X Annual BARA meeting -Brussels, Belgium, 2010
O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.
PubMed 16418039
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane Blocks in Patients Scheduled for an Abdominoplasty. A Prospective, Randomized, Double Blind, Comparison Between the Posterior Approach and Placebo.
- ClinicalTrials.gov ID
- NCT01278264
- Acronym / sponsor ID
- TAPA / ANESAB001
- Conditions
- Post Operative Pain
- Keywords
- Transversus abdominis plane block, Ultrasound guided, Abdominoplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique Saint-Jean, BruxellesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 17 Jan 2011 (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.
Comparing morphine consumption and recovery with two different TAP block techniques after abdominoplasty.
Detailed description
TAP blocks have the potential to become an important part of multi-modal analgesia after abdominal surgery (1,2). Originally Dr J McDonnell described a blind double pop technique, trough the triangle of Petit, with up to 48 hours of analgesia (3,4). Dr P Hebbard described an ultrasound based technique with a subcostal (for supra-umbilical analgesia) and an axillary mid-line injection (for sub-umbilical analgesia) in the TAP, with reported analgesia for up to 8 hours (5,6). Recently Dr J McDonnell presented data showing para vertebral spread (up to L5) of the (high dose, low concentration) local anaesthetic explaining the prolonged analgesic effect (7,8). In 2007 Dr Blanco described an ultrasound guided technique for the posterior infiltration as performed by McDonnell (9). Our limited observational comparison between both block techniques confirms this difference. We decided to compare both techniques (the ultrasound guided single shot subcostal injection, the aTAP-group (Hebbard is from Australia) and the ultrasound guided posterior injection, the iTAP-group (McDonnell is from Ireland). We will use the same volume and concentration of local anesthetic and we will asses their analgesic efficacy and improvement in quality of recovery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iTAP-group | Active comparator | Drug: Ropivacaine 0.25%, 0.5 ml/kgPosterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle |
| aTAP-group | Active comparator | Drug: Ropivacaine 0.25%, 0.5 ml/kgSubcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eligible for abdominoplasty
- ASA 1-2
- Fluent french/dutch/english
Key exclusion criteria (3 listed)
- History of allergy to local anaesthetics
- Chronic opioids abuse
- Pregnant 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 |
|---|---|---|
| Ropivacaine 0.25%, 0.5 ml/kgPosterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle | Drug | iTAP-group |
| Ropivacaine 0.25%, 0.5 ml/kgSubcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet | Drug | aTAP-group |
Primary outcome
Morphine consumption
Time frame: 48 hours
Consumption measured by the use of the PCA pump
6 secondary outcomes
VAS score
Time frame: 48 hours
Post operative nausea and vomiting
Time frame: 48 hours
Constipation
Time frame: 48 hours
Pruritus
Time frame: 48 hours
First time to get up
Time frame: 48 hours
First time to eat
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2011.
- Background: PubMed 21154380Charlton S, Cyna AM, Middleton P, Griffiths JD. Perioperative transversus abdominis plane (TAP) blocks for analgesia after abdominal surgery. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD007705. doi: 10.1002/14651858.CD007705.pub2.
- Background: PubMed 20175754Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.
- Background: PubMed 19020158Carney J, McDonnell JG, Ochana A, Bhinder R, Laffey JG. The transversus abdominis plane block provides effective postoperative analgesia in patients undergoing total abdominal hysterectomy. Anesth Analg. 2008 Dec;107(6):2056-60. doi: 10.1213/ane.0b013e3181871313.
- Background6. McDonnell J. XXIX Annual ESRA congress - Porto, Portugal, 2010.
- Background7. Blanco R. TAP block under ultrasound guidance: the description of a
- Background: PubMed 20861094Griffiths JD, Barron FA, Grant S, Bjorksten AR, Hebbard P, Royse CF. Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. Br J Anaesth. 2010 Dec;105(6):853-6. doi: 10.1093/bja/aeq255. Epub 2010 Sep 22.
- Background: PubMed 21148651Ingrande J, Lemmens HJ. Dose adjustment of anaesthetics in the morbidly obese. Br J Anaesth. 2010 Dec;105 Suppl 1:i16-23. doi: 10.1093/bja/aeq312.
- Background5. McDonnell J. Ultrasound guided abdominal wall blocks. X Annual BARA meeting -Brussels, Belgium, 2010
- Background: PubMed 16418039O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.
Related trials for Post Operative Pain
RecruitingPhase 4
The Impact of Perioperative Lidocaine Infusions on Enhanced Recovery After Non-Cardiac Surgery
Pain, Post Operative Analgesia
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Recruiting
Anterior Nerves of the Knee Block Versus Femoral Nerve Block for Knee Arthroscopy
Postoperative Pain, Knee Arthroscopy
Active, not recruiting
THE EFFECT OF FILLING MATERIAL AND PLACEMENT TECHNIQUE ON POSTOPERATIVE PAIN IN NON-SURGICAL ENDODONTIC RETREATMENT: A RANDOMIZED CLINICAL TRIAL
Retreatment, Endodontic Diseases
Recruiting
The Effect of Virtual Reality Headsets on Pain, Anxiety, Patient Satisfaction, and Physiological Parameters in Patients Undergoing Open-Heart Surgery
Pain After Surgery, Pain and Anxiety
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.
Arnaud G Bosteels, MD principal investigator
Clinique Saint-Jean, Bruxelles
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 Ropivacaine 0.25%, 0.5 ml/kg in people with Post Operative Pain, run by Clinique Saint-Jean, Bruxelles 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 3 inclusion and 3 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 27 Apr 2011. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud G Bosteels, MD (02 221 97 62 ext. 0032, Abosteels@clstjean.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine consumption (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01278264, which also lists 9 linked publications.
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 27 Apr 2011.