Pain After Carpal Tunnel ReleaseNCT02141178
Comparison of Bupivacaine and Exparel for Carpal Tunnel Release
A study testing Bupivacaine and Exparel in people with Pain After Carpal Tunnel Release, run by University of Pittsburgh at 1 site in United States.
Trial summary
Carpal tunnel syndrome is one of the most common surgeries performed per year in the United States, accounting for over 600,000 surgeries. The procedure is commonly performed under light sedation and local anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pain After Carpal Tunnel Release
- What is being tested?
- Bupivacaine and Exparel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2015
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with carpal tunnel syndrome undergoing surgery
Who cannot join
- Non english speaking
- Allergy to bupivacaine or exparel
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Does Long-Acting Liposomal Bupivacaine Provide Improved Pain Relief Over Bupivicaine Alone in Carpal Tunnel Release?
Carpal tunnel syndrome is one of the most common surgeries performed per year in the United States, accounting for over 600,000 surgeries. The procedure is commonly performed under light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72 hours post-operatively. By decreasing post-operative pain through the use of a long-acting local anesthetic, the use of narcotic pain medications may be decreased and patient satisfaction scores may increase.
The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine with respect to post-operative pain control, narcotic usage, and patient satisfaction after carpal tunnel release.
- Conditions
- Pain After Carpal Tunnel Release
- Being tested
- Bupivacaine, Exparel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
ExparelDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Patients will received 0.5% Bupivacaine subcutaneously for local anesthesia during surgery Receives: Drug: Bupivacaine |
| Exparel | Experimental | Patients will received Exparel subcutaneously for local anesthesia during surgery Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be evaluated using an 11-point ordinal scale (0-10)
Measured: Starting immediately after surgery and then every 8 hours for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2014 (estimated)
- Study startMay 2015
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: No IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Carpal Tunnel ReleaseStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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 N/A
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02141178
- Sponsor's protocol ID
- PRO14040418
- Status last verified
- Jan 2016
- First submitted
- 12 May 2014
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Long-Acting Liposomal Bupivacaine Provide Improved Pain Relief Over Bupivicaine Alone in Carpal Tunnel Release?
- ClinicalTrials.gov ID
- NCT02141178
- Acronym / sponsor ID
- PRO14040418
- Conditions
- Pain After Carpal Tunnel Release
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 May 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.
Carpal tunnel syndrome is one of the most common surgeries performed per year in the United States, accounting for over 600,000 surgeries. The procedure is commonly performed under light sedation and local anesthesia. Bupivicaine, a long acting local anesthetic, has been used to allow extended pain relief for 8-10 hours after carpal tunnel release. Exparel, a liposomal bupivicaine formulation, has been documented to provide pain relief for up to 72 hours post-operatively. By decreasing post-operative pain through the use of a long-acting local anesthetic, the use of narcotic pain medications may be decreased and patient satisfaction scores may increase.
The purpose of this study is to prospectively compare bupivicaine and liposomal bupivicaine with respect to post-operative pain control, narcotic usage, and patient satisfaction after carpal tunnel release.
Study design
- Primary purpose
- Treatment
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: BupivacainePatients will received 0.5% Bupivacaine subcutaneously for local anesthesia during surgery |
| Exparel | Experimental | Drug: ExparelPatients will received Exparel subcutaneously for local anesthesia during surgery |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with carpal tunnel syndrome undergoing surgery
Key exclusion criteria (2 listed)
- Non english speaking
- Allergy to bupivacaine or exparel
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 |
|---|---|---|
| Bupivacaine | Drug | Bupivacaine |
| Exparel | Drug | Exparel |
Primary outcome
Pain
Time frame: Starting immediately after surgery and then every 8 hours for 10 days
Pain will be evaluated using an 11-point ordinal scale (0-10)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Exparel in people with Pain After Carpal Tunnel Release, run by University of Pittsburgh 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 1 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 Jan 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pain (time frame: Starting immediately after surgery and then every 8 hours for 10 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 5 Jan 2016.