PainNCT02052180
Early Post-Operative Pain Control Following Wrist Operations
A study testing Exparel in people with Pain, run by University of Tennessee at 1 site in United States.
Trial summary
The purpose of this study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use of the standard local anesthetic, Marcaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Exparel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to May 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- ASA physical status 1-3
- Undergoing either carpometacarpal arthroplasty or proximal row carpectomy operation
- Physically and mentally able to participate in the study and complete all study assessments
- Able to voluntarily give fully informed consent to participate in this study and complete all study assessments within the timeframes required.
Who cannot join
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL
- Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study
- Any chronic condition requiring use of opioids for treatment of the medical condition for three (3) months or more
- Confirmed pregnancy at time of enrollment
- Patients unable to comply with the study requirements, i.e. inaccessible by phone, or deaf
Trial locations and contacts
1 site in 1 country.
United States1 site
UTCOM Chattanooga Department of Plastic Surgery
Chattanooga, Tennessee, 37403
About this study
Official title: Bupivicaine Extended-Release Liposome Injection Versus Marcaine for Early Post-Operative Pain Control Following Wrist Operations
The purpose of this study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use of the standard local anesthetic, Marcaine.
- Conditions
- Pain
- Being tested
- Exparel, Marcaine (Control)
- Keywords
- Carpalmetacarpal arthroplasty, Proximal row carpectomy, Post-operative pain control, Exparel, Marcaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
EXPAREL arm: one vial (266 mg/20 mL) of EXPAREL (Bupivicaine Extended-Release Liposome, 13.3mg/ml), undiluted, will be administered for each of the specified procedures.
Marcaine (Control)Drug
15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Experimental | EXPAREL arm: one vial (266 mg/20 mL) of EXPAREL (Bupivicaine Extended-Release Liposome, 13.3mg/ml), undiluted, will be administered for each of the specified procedures. Receives: Drug: Exparel |
| Control | Active comparator | 15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice. Receives: Drug: Marcaine (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain
Pain measured by Numeric Rating Scale (NRS)
Measured: Pre-op, Post-op days: 1,2,3,4, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason P. Rehm, MD, Principal investigator, University of Tennessee College of Medicine Chattanooga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02052180
- Sponsor's protocol ID
- BVM-3-27
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivicaine Extended-Release Liposome Injection Versus Marcaine for Early Post-Operative Pain Control Following Wrist Operations
- ClinicalTrials.gov ID
- NCT02052180
- Acronym / sponsor ID
- BVM-3-27
- Conditions
- Pain
- Keywords
- Carpalmetacarpal arthroplasty, Proximal row carpectomy, Post-operative pain control, Exparel, Marcaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 31 Jan 2014 (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 study is to demonstrate improved pain control and outcomes in wrist operations with the use of a long-acting local anesthetic, EXPAREL, when compared to the use of the standard local anesthetic, Marcaine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel | Experimental | Drug: ExparelEXPAREL arm: one vial (266 mg/20 mL) of EXPAREL (Bupivicaine Extended-Release Liposome, 13.3mg/ml), undiluted, will be administered for each of the specified procedures. |
| Control | Active comparator | Drug: Marcaine (Control)15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- ASA physical status 1-3
- Undergoing either carpometacarpal arthroplasty or proximal row carpectomy operation
- Physically and mentally able to participate in the study and complete all study assessments
- Able to voluntarily give fully informed consent to participate in this study and complete all study assessments within the timeframes required.
Key exclusion criteria (6 listed)
- History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
- Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL
- Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study
- Any chronic condition requiring use of opioids for treatment of the medical condition for three (3) months or more
- Confirmed pregnancy at time of enrollment
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 |
|---|---|---|
| ExparelEXPAREL arm: one vial (266 mg/20 mL) of EXPAREL (Bupivicaine Extended-Release Liposome, 13.3mg/ml), undiluted, will be administered for each of the specified procedures. | Drug | Exparel |
| Marcaine (Control)15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice. | Drug | Control |
Primary outcome
Changes in Pain
Time frame: Pre-op, Post-op days: 1,2,3,4, and 14
Pain measured by Numeric Rating Scale (NRS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2014.
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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.
Jason P. Rehm, MD principal investigator
University of Tennessee College of Medicine Chattanooga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exparel in people with Pain, run by University of Tennessee 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 5 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: status not confirmed, as of the sponsor's last update on 31 Jan 2014. 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.
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?
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?
Changes in Pain (time frame: Pre-op, Post-op days: 1,2,3,4, and 14). 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 31 Jan 2014.