Rotator Cuff InjuryPhase 4NCT03738696
Liposomal Bupivacaine in Rotator Cuff Repair
A Phase 4 study testing Exparel and Ropivacaine in people with Rotator Cuff Injury, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rotator Cuff Injury
- What is being tested?
- Exparel and Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2019to 1 Jan 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing outpatient arthroscopic rotator cuff repair
- Greater than or equal to 19 years of age at the time of surgery
Who cannot join
- Planned operative fixation of the biceps tendon or acromioclavicular joint
- Opioid use 6 weeks before surgery
- Gabapentin use 6 weeks before surgery
- History of prior shoulder surgery on the operative limb
- Severe pulmonary dysfunction
- Diagnosis of chronic pain, fibromyalgia or other somatosensory disorder(s)
- History of radicular pain or neuropathy in the operative limb
- Patients who are currently incapacitated for medical decision making
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.
- Conditions
- Rotator Cuff Injury
- Being tested
- Exparel, Ropivacaine
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Also called liposomal bupivacaine
A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
RopivacaineDrug
A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine Interscalene Block | Experimental | Interscalene block:
* 10cc (133mg) liposomal bupivacaine;PLUS
* 10cc 0.25% bupivacaine Receives: Drug: Exparel |
| Ropivacaine Interscalene Catheter | Active comparator | * 20cc 0.25% bupivacaine interscalene block; PLUS
* Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs) Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Postoperative Pain Scores Over a 96 Hour Timeframe
Visual analog pain scores after operation [0-10, with 10 being the worst pain]
Measured: Up to 96 hrs postoperative
Secondary outcomes (5)
Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe
oral morphine equivalents of all opioid-containing medications received
Measured: Up to 96 hrs
Average Analgesia Satisfaction Over a 96 Hour Timeframe
Likert scale of analgesia satisfaction [0-5, with 5 being the most satisfied]
Measured: Up to 96 hrs
Percentage of Participants With Analgesia Complications
Complications resulting from the method of analgesia utilized
Measured: Up to 96 hrs
Average Sleep Quality Over a 96 Hour Timeframe
Scale of sleep quality [0-10, with 10 being the most satisfied]
Measured: Up to 96 hrs postoperative
Average Hours of Painless Sleep
Hours of sleep uninterrupted by pain [numerical, hours]
Measured: Up to 96 hrs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start15 Dec 2019
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
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 Rotator Cuff InjuryStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Principal investigator, Amit Momaya, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738696
- Sponsor's protocol ID
- IRB-300002544
- Status last verified
- May 2024
- First submitted
- 7 Nov 2018
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Liposomal Bupivacaine in Arthroscopic Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT03738696
- Acronym / sponsor ID
- IRB-300002544
- Conditions
- Rotator Cuff Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 15 Dec 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of interscalene liposomal bupivacaine in controlling postoperative pain scores, oral morphine equivalents and sleep quality after arthroscopic rotator cuff repair surgery as compared to interscalene catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine Interscalene Block | Experimental | Drug: ExparelInterscalene block: * 10cc (133mg) liposomal bupivacaine;PLUS * 10cc 0.25% bupivacaine |
| Ropivacaine Interscalene Catheter | Active comparator | Drug: Ropivacaine* 20cc 0.25% bupivacaine interscalene block; PLUS * Ropivacaine 0.25% interscalene catheter (6ml/hr for 48hrs) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing outpatient arthroscopic rotator cuff repair
- Greater than or equal to 19 years of age at the time of surgery
Key exclusion criteria (8 listed)
- Planned operative fixation of the biceps tendon or acromioclavicular joint
- Opioid use 6 weeks before surgery
- Gabapentin use 6 weeks before surgery
- History of prior shoulder surgery on the operative limb
- Severe pulmonary dysfunction
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 |
|---|---|---|
| ExparelAlso: liposomal bupivacaineA long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain | Drug | Liposomal bupivacaine Interscalene Block |
| RopivacaineA short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain | Drug | Ropivacaine Interscalene Catheter |
Primary outcome
Average Postoperative Pain Scores Over a 96 Hour Timeframe
Time frame: Up to 96 hrs postoperative
Visual analog pain scores after operation [0-10, with 10 being the worst pain]
5 secondary outcomes
Average Postoperative Oral Morphine Equivalents Over a 96 Hour Timeframe
Time frame: Up to 96 hrs
Average Analgesia Satisfaction Over a 96 Hour Timeframe
Time frame: Up to 96 hrs
Percentage of Participants With Analgesia Complications
Time frame: Up to 96 hrs
Average Sleep Quality Over a 96 Hour Timeframe
Time frame: Up to 96 hrs postoperative
Average Hours of Painless Sleep
Time frame: Up to 96 hrs postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Exparel and Ropivacaine in people with Rotator Cuff Injury, run by University of Alabama at Birmingham 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 2 inclusion and 8 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 16 May 2024. 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 16 May 2024). 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?
Average Postoperative Pain Scores Over a 96 Hour Timeframe (time frame: Up to 96 hrs postoperative). 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 16 May 2024.