MammaplastyPhase 4NCT02662036
Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
A Phase 4 study testing Bupivicaine HCL and Liposomal bupivacaine in people with Mammaplasty, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mammaplasty
- What is being tested?
- Bupivicaine HCL and Liposomal bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2016to 8 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).
- At least 18 years of age.
- Female.
- Able to understand and willing to sign a written informed consent document.
Who cannot join
- Cognitive impairment.
- History of abdominal surgery precluding free flap donor site.
- Allergy or intolerance to bupivacaine or "amide" anesthetics.
- Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.
- Conditions
- Mammaplasty
- Being tested
- Bupivicaine HCL, Liposomal bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivicaine HCLDrug
Also called Bupivicaine
Liposomal bupivacaineDrug
Also called Exparel
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Bupivicaine | Active comparator | -TAP block of 30 cc of 0.25% bupivicaine Receives: Drug: Bupivicaine HCL |
| Group 2: Liposomal bupivacaine | Experimental | -TAP block of 266 mg/30 cc liposomal bupivacaine Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Measured: Up to day of discharge from hospital (expected hospital stay of 5 days)
Secondary outcomes (10)
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
Measured: Up to day of discharge from hospital (expected hospital stay of 5 days)
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
Measured: Up to day of discharge from hospital, up to 7 days
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
Measured: Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
Measured: Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
- Pain scale uses Wong-Baker FACES Pain Rating Scale
- The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Measured: 12 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
- Pain scale uses Wong-Baker FACES Pain Rating Scale
- The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Measured: 24 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
- Pain scale uses Wong-Baker FACES Pain Rating Scale
- The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Measured: 48 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
- Pain scale uses Wong-Baker FACES Pain Rating Scale
- The scale uses cartoon faces ranging from 0-10 with 0 meaning no pain and 10 meaning worst possible pain
Measured: 72 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
- Quality of Recovery -15 questionnaire
- Part A has 10 questions that asks how the participant has been feeling in the last 24 hours with answers ranging from 0=none of the time to 10=all of the time
- Part B has 5 questions asking the participant if they have had any of the following including pain, nausea, vomiting, anxiety, and depression) with answers ranging from 0=none of the time to 10=all of the time.
- The total score allowed is 150 (range 0-150) with the higher the number the worse the participant is feeling and the lower the number the better the participant is feeling
Measured: At post operative day 2, discharge, and at 1-2 week follow-up
Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics
Measured: Up to 2 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start29 Feb 2016
- Primary completion26 Feb 2018
- Study completion8 Mar 2018
Why it stopped: Interim analysis showed that there was no difference between the two drugs
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MammaplastyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terence Myckatyn, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662036
- Sponsor's protocol ID
- 201601064
- Status last verified
- Feb 2019
- First submitted
- 20 Jan 2016
- Last updated
- 18 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Trial to Assess Analgesic Efficacy of Liposomal Bupivacaine vs. Bupivacaine HCL as a Tap Block After Abdominally Based Autologous Breast Reconstruction
- ClinicalTrials.gov ID
- NCT02662036
- Acronym / sponsor ID
- 201601064
- Conditions
- Mammaplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed that there was no difference between the two drugs
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 26 Feb 2018 (actual)
- Study completion
- 8 Mar 2018 (actual)
- First posted
- 25 Jan 2016 (estimated)
- Results
- Posted 18 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of analgesia provided by liposomal bupivacaine (Exparel) when compared to bupivacaine HCL as a transverse abdominis plane (TAP) block in terms of discharge milestones, opioid use, costs, and patient-reported satisfaction at 12, 24, and 72 hours. The investigators propose that Exparel will lower opioid use, length of stay, and overall cost of abdominally-based autologous breast reconstruction, and will lead to greater patient satisfaction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Bupivicaine | Active comparator | Drug: Bupivicaine HCL-TAP block of 30 cc of 0.25% bupivicaine |
| Group 2: Liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaine-TAP block of 266 mg/30 cc liposomal bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Scheduled for abdominal-based autologous breast reconstruction (DIEP, MS-TRAM, or TRAM).
- At least 18 years of age.
- Female.
- Able to understand and willing to sign a written informed consent document.
Key exclusion criteria (5 listed)
- Cognitive impairment.
- History of abdominal surgery precluding free flap donor site.
- Allergy or intolerance to bupivacaine or "amide" anesthetics.
- Significant preoperative chronic pain (requiring daily narcotics) or neuropathic pain (requiring daily use of pregabalin or gabapentin) within the previous 3 months.
- Pregnant or breastfeeding.
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 |
|---|---|---|
| Bupivicaine HCLAlso: Bupivicaine | Drug | Group 1: Bupivicaine |
| Liposomal bupivacaineAlso: Exparel | Drug | Group 2: Liposomal bupivacaine |
Primary outcome
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay
Time frame: Up to day of discharge from hospital (expected hospital stay of 5 days)
10 secondary outcomes
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Antiemetic Use During the Hospital Stay
Time frame: Up to day of discharge from hospital (expected hospital stay of 5 days)
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Length of Hospital Stay
Time frame: Up to day of discharge from hospital, up to 7 days
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Time Until Ambulation
Time frame: Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Duration of Urinary Catheter
Time frame: Up to 2 weeks post-operation
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Time frame: 12 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Time frame: 24 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Time frame: 48 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Pain Scores
Time frame: 72 hours after surgery
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Change From Baseline in Patient Satisfaction With Recovery
Time frame: At post operative day 2, discharge, and at 1-2 week follow-up
Cost of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl When Accounting for Length of Hospital Stay and Use of Other Analgesics
Time frame: Up to 2 weeks post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Terence Myckatyn, M.D. principal investigator
Washington University School of Medicine
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 Bupivicaine HCL and Liposomal bupivacaine in people with Mammaplasty, run by Washington University School of Medicine at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 18 Feb 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Analgesic Effectiveness of Liposomal Bupivacaine (Exparel) Versus Bupivacaine HCl as Measured by Opioid Use During Hospital Stay (time frame: Up to day of discharge from hospital (expected hospital stay of 5 days)). 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 18 Feb 2019.