Rotator Cuff TearsPhase 4NCT06575010
Exparel v Dexamethasone in RCR
A Phase 4 study testing Liposomal bupivacaine, Bupivacaine Hcl 0.5% Inj and Dexamethasone in people with Rotator Cuff Tears and Postoperative Pain, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Postoperative Pain
- What is being tested?
- Liposomal bupivacaine, Bupivacaine Hcl 0.5% Inj and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Aug 2024to 30 Aug 2025
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants having a primary rotator cuff repair
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
- Ability to provide informed consent
Who cannot join
- Revision rotator cuff repair (RCR) cases
- Participants having an open RCR
- Allergies and/or medical contra-indications to study medications
- Non-English speakers
- Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
- Rotator cuff repair needing Graft Augmentation
Show all 9Show fewer
- Known alcohol or narcotic abuse history
- Existing contract with a pain specialist due to underlying preoperative pain syndrome
- Preoperative opioid use within the 3 months prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.
- Conditions
- Rotator Cuff Tears, Postoperative Pain
- Being tested
- Liposomal bupivacaine, Bupivacaine Hcl 0.5% Inj, Dexamethasone
- Medical subject headings
- Rotator Cuff Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery
Bupivacaine Hcl 0.5% InjDrug
0.75% bupivacaine will be given in the shoulder block prior to surgery
DexamethasoneDrug
10 mg Dexamethasone will be given in the shoulder block prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Shoulder Block using Exparel | Active comparator | Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery. Receives: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hcl 0.5% Inj |
| Group 2: Shoulder Block using Exparel + Dexamethasone | Active comparator | Participants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery. Receives: Drug: Liposomal bupivacaine; Drug: Bupivacaine Hcl 0.5% Inj; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative narcotic medication use
Participants will be asked to record the amount of medication they take to control pain after surgery
Measured: 14 days
Postoperative pain levels
This will be measured by providing participants the visual analog scale (VAS) questionnaire as well as a postoperative pain recording diary to complete after surgery
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start26 Aug 2024 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575010
- Sponsor's protocol ID
- 2024-0726SNAM
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06575010
- Acronym / sponsor ID
- 2024-0726SNAM
- Conditions
- Rotator Cuff Tears, Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 26 Aug 2024 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- 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.
Effective and safe control of pain after shoulder surgery is an important component of the post-surgical process. Patients who are comfortable in the early period after surgery are more satisfied with their experience and are better able to participate in rehabilitation exercises during their stay in the hospital. As surgeons and health care systems in the United States find themselves in the middle of an opioid epidemic, it is necessary to discover different options to provide patients pain relief that are both effective and safe in an effort to decrease the amount of pain medication used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Shoulder Block using Exparel | Active comparator | Drug: Liposomal bupivacaine, Drug: Bupivacaine Hcl 0.5% InjParticipants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + bupivacaine given in their shoulder block before surgery. |
| Group 2: Shoulder Block using Exparel + Dexamethasone | Active comparator | Drug: Liposomal bupivacaine, Drug: Bupivacaine Hcl 0.5% Inj, Drug: DexamethasoneParticipants having rotator cuff repair surgery will receive Liposomal bupivacaine (Exparel) + Dexamethasone + bupivacaine given in their shoulder block before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants having a primary rotator cuff repair
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
- Ability to provide informed consent
Key exclusion criteria (9 listed)
- Revision rotator cuff repair (RCR) cases
- Participants having an open RCR
- Allergies and/or medical contra-indications to study medications
- Non-English speakers
- Participants who are pregnant, plan to become pregnant and do not utilize adequate contraceptive means, or are currently breastfeeding (all patients who have the potential to be pregnant are administered a urine beta-HCG pregnancy test, with suspected false-positive or equivocal urine pregnancy tests followed by a more specific serum pregnancy test)
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 |
|---|---|---|
| Liposomal bupivacaine20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery | Drug | Group 1: Shoulder Block using Exparel, Group 2: Shoulder Block using Exparel + Dexamethasone |
| Bupivacaine Hcl 0.5% Inj0.75% bupivacaine will be given in the shoulder block prior to surgery | Drug | Group 1: Shoulder Block using Exparel, Group 2: Shoulder Block using Exparel + Dexamethasone |
| Dexamethasone10 mg Dexamethasone will be given in the shoulder block prior to surgery | Drug | Group 2: Shoulder Block using Exparel + Dexamethasone |
Primary outcome
Postoperative narcotic medication use
Time frame: 14 days
Participants will be asked to record the amount of medication they take to control pain after surgery
Postoperative pain levels
Time frame: 14 days
This will be measured by providing participants the visual analog scale (VAS) questionnaire as well as a postoperative pain recording diary to complete after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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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 Liposomal bupivacaine, Bupivacaine Hcl 0.5% Inj and Dexamethasone in people with Rotator Cuff Tears and Postoperative Pain, run by Rothman Institute Orthopaedics 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 9 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 28 Aug 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?
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?
Postoperative narcotic medication use (time frame: 14 days). The study lists 2 primary outcomes in all. 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 28 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.