Rotator Cuff TearsPhase 4NCT06139666
The Effect of Liposomal Bupivacaine Nerve Block (Exparel) in Rotator Cuff Surgery
A Phase 4 study testing Exparel Injectable Solution and Bupivacaine Injectable Solution in people with Rotator Cuff Tears and Postoperative Pain, run by Cooper Norcross Health at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Postoperative Pain, Opioid Use
- What is being tested?
- Exparel Injectable Solution and Bupivacaine Injectable Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 24 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients above 18 years of age
- Undergoing rotator cuff surgery or shoulder arthroscopy using an interscalene block
Who cannot join
- Patients with preexisting chronic obstructive pulmonary disease (COPD) or respiratory issues precluding the use of an interscalene block
- Pregnant women, women nursing infants
- Patients with preexisting liver disease
- Patients unwilling to have interscalene block performed
- Patients allergic to bupivacaine, liposomal bupivacaine, or any ingredients contained within the two drugs listed
Trial locations and contacts
1 site in 1 country.
United States1 site
Cooper University Hospital
Camden, New Jersey, 08103
About this study
Official title: The Effect of Liposomal Bupivacaine Nerve Block on Postoperative Pain After a Rotator Cuff Repair or Shoulder Arthroscopy
The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone.
The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone.
Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.
Read the detailed description
Nerve blocks are typically performed for shoulder surgery for perioperative pain control. This is performed in the shoulder using an interscalene block, which is localized between the anterior and middle scalene muscles in the neck and provides analgesia to the clavicle, shoulder and its capsule and some to the arm. Using this method allows for conscious sedation to be used over general anesthesia, mitigating the dangers associated with the latter, and also comes with the added benefit of providing improved postoperative analgesia.
Bupivacaine is the medication that is typically used for these procedures to provide the analgesia in these sensory patterns. It works by binding to the intracellular portion of voltage-gated sodium channels, preventing depolarization of the nerve and subsequently inhibiting transmission of nerve signals. Typical interscalene blocks have been shown to have pain control for 6-8 hours and have an effect decreasing opioid usage for up to 24 hours. Liposomal bupivacaine, trade name Exparel, was recently introduced as an alternative to drugs such as bupivacaine, but boasting a longer duration of action. In Exparel, bupivacaine is stored in liposomes, which allows for a controlled and longer duration of release of the analgesia-producing molecules. This allows nerve blockades to last longer, allowing for longer prevention of neurotransmitter release. It was initially only approved for local infiltration, most notably in the joint capsule for a total knee arthroplasty. Recently however, it was FDA approved for interscalene blocks, opening up a new avenue for pain control modalities. No studies have yet been performed comparing the difference in analgesia provided by liposomal bupivacaine compared to bupivacaine alone in the context of interscalene blocks in rotator cuff surgery
Nerve blocks with local anesthetics has been proven safe and effective for perioperative pain control. With recent talks of healthcare providers decreasing narcotic usage postoperatively in an effort to prevent opiate addiction, longer acting nerve blocks are becoming more and more appealing. By increasing the duration of a nerve blockade, postoperative narcotic use may be significantly decreased, with minimal risk of harm to the patient.
This is a prospective, double-blinded (surgeon and patient) randomized therapeutic trial. Patients will either receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or will receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine), which has recently been approved and instituted. These blocks (both) are currently in practice at the study institution and the decision of which to use is currently up to the anesthesiologist. It is current practice that every patient undergoing a rotator cuff surgery is offered a nerve block. Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.
Patents will present for surgery and follow up postoperatively as they would routinely for rotator cuff surgery or shoulder arthroscopy. The anesthesiologist administering the injection will be not be blinded to the mixture of injection (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care.
When discharged home, patients will be asked to keep a log of their narcotic consumption, as well as bringing in their prescription vial to the postoperative follow up and also logging other medications that are consumed during this time period. They will also be asked to log their pain scores in the form of a standardized VAS pain scale form that they will fill out daily until their first follow up visit.
- Conditions
- Rotator Cuff Tears, Postoperative Pain, Opioid Use
- Being tested
- Exparel Injectable Solution, Bupivacaine Injectable Solution
- Keywords
- Rotator Cuff Repair, Postoperative Pain Control, Orthopedic Surgery, Anesthesia, Nerve block, bupivacaine, Liposomal Bupivacaine
- 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.
Exparel Injectable SolutionDrug
Patients randomized to this arm will receive an interscalene block with Exparel solution, an extended-release formulation of bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine), approved for use at the study institution. This will be administered preoperatively on the day of surgery. The anesthesiologist administering the injection will be not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care.
After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count.
Bupivacaine Injectable SolutionDrug
Patients randomized to this arm will receive a standard interscalene block consisting of 25 cc of bupivacaine alone. This will be administered preoperatively on the day of surgery.
The anesthesiologist administering the injection will not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care.
After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count.
| Study group | Role | What they receive |
|---|---|---|
| Control- Bupivacaine Alone | Active comparator | patients will receive a standard interscalene block with bupivacaine alone (25 cc of bupivacaine) Receives: Drug: Bupivacaine Injectable Solution |
| Study- Exparel | Experimental | patients will receive an interscalene block with Exparel solution, which is an extended-release formulation of bupivacaine consisting of 10cc liposomal bupivacaine mixed with 15cc bupivacaine. This is approved and used at the study institution Receives: Drug: Exparel Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of pain medications
Patients will be asked to bring their bottle of pain medication prescribed after surgery to their first office visit so a narcotic pill count can be performed. Patients will record their pain pill consumption every day for 2 weeks in a study journal. The journal containing the pill count will be collected at the 2 week visit in the office. Opioid consumption will be quantified as milligram of opioid equivalents (MME).
Measured: 2 week postoperative visit
Secondary outcomes (1)
Pain severity
Patients will rate their pain using the VAS pain scale survey. The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). These results will be recorded every day for the first 2 weeks in a study journal. The journal containing the VAS scores will be collected at the 2 week visit in the office. The VAS will be administered again at the 6 week and 12 week visit.
Measured: Every day for the first 2 weeks, and a one-time survey at the 6 week and 12 week visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start11 Jul 2019
- Primary completion1 Jun 2024
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Model description
- Prospective, double-blinded (surgeon and patient) randomized therapeutic trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Fedorka MD, Cooper Norcross Health
- Investigators
- Catherine J Fedorka, MD, Principal investigator, Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139666
- Sponsor's protocol ID
- IRB 19-063
- Status last verified
- Dec 2025
- First submitted
- 26 Jul 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim DH, Liu J, Beathe JC, Lin Y, Wetmore DS, Kim SJ, Haskins SC, Garvin S, Oxendine JA, Ho MC, Allen AA, Popovic M, Gbaje E, Wu CL, Memtsoudis SG. Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial. Anesthesiology. 2022 Mar 1;136(3):434-447. doi: 10.1097/ALN.0000000000004111.
PubMed 35041742Wiederhold BD, Garmon EH, Peterson E, Stevens JB, O'Rourke MC. Nerve Block Anesthesia(Archived). 2023 Apr 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431109/
PubMed 28613761Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7.
PubMed 25750943Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.
PubMed 27673545Kaye AD, Armstead-Williams C, Hyatali F, Cox KS, Kaye RJ, Eng LK, Farooq Anwar MA, Patel PV, Patil S, Cornett EM. Exparel for Postoperative Pain Management: a Comprehensive Review. Curr Pain Headache Rep. 2020 Oct 23;24(11):73. doi: 10.1007/s11916-020-00905-4.
PubMed 33098008Fedorka CJ, Tornberg HN, Rivera-Pintado C, Gentile PM, Russo D, Boniello M, Hunter K, Desai R, Soni D, Kleiner MT, Dodson G. Liposomal Bupivacaine + Bupivacaine Versus Bupivacaine Interscalene Nerve Block Effect on Pain After Rotator Cuff Repair: A Randomized Control Trial. J Am Acad Orthop Surg. 2026 Aug 15;34(16):e2216-e2225. doi: 10.5435/JAAOS-D-25-01002. Epub 2025 Dec 24.
PubMed 41468585
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Liposomal Bupivacaine Nerve Block on Postoperative Pain After a Rotator Cuff Repair or Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT06139666
- Acronym / sponsor ID
- IRB 19-063
- Conditions
- Rotator Cuff Tears, Postoperative Pain, Opioid Use
- Keywords
- Rotator Cuff Repair, Postoperative Pain Control, Orthopedic Surgery, Anesthesia, Nerve block, bupivacaine, Liposomal Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 18 Nov 2023 (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.
The goal of this clinical trial is to investigate if there is a difference in pain after an arthroscopic rotator cuff surgery when a nerve block is performed with liposomal bupivacaine versus the standard treatment of bupivacaine alone.
The main question aims to answer if patients who receive liposomal bupivacaine have better pain control and lower postoperative opioid consumption compared to bupivacaine alone.
Participants be randomized to either the control group to receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or the experimental group to receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine). Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.
Detailed description
Nerve blocks are typically performed for shoulder surgery for perioperative pain control. This is performed in the shoulder using an interscalene block, which is localized between the anterior and middle scalene muscles in the neck and provides analgesia to the clavicle, shoulder and its capsule and some to the arm. Using this method allows for conscious sedation to be used over general anesthesia, mitigating the dangers associated with the latter, and also comes with the added benefit of providing improved postoperative analgesia.
Bupivacaine is the medication that is typically used for these procedures to provide the analgesia in these sensory patterns. It works by binding to the intracellular portion of voltage-gated sodium channels, preventing depolarization of the nerve and subsequently inhibiting transmission of nerve signals. Typical interscalene blocks have been shown to have pain control for 6-8 hours and have an effect decreasing opioid usage for up to 24 hours. Liposomal bupivacaine, trade name Exparel, was recently introduced as an alternative to drugs such as bupivacaine, but boasting a longer duration of action. In Exparel, bupivacaine is stored in liposomes, which allows for a controlled and longer duration of release of the analgesia-producing molecules. This allows nerve blockades to last longer, allowing for longer prevention of neurotransmitter release. It was initially only approved for local infiltration, most notably in the joint capsule for a total knee arthroplasty. Recently however, it was FDA approved for interscalene blocks, opening up a new avenue for pain control modalities. No studies have yet been performed comparing the difference in analgesia provided by liposomal bupivacaine compared to bupivacaine alone in the context of interscalene blocks in rotator cuff surgery
Nerve blocks with local anesthetics has been proven safe and effective for perioperative pain control. With recent talks of healthcare providers decreasing narcotic usage postoperatively in an effort to prevent opiate addiction, longer acting nerve blocks are becoming more and more appealing. By increasing the duration of a nerve blockade, postoperative narcotic use may be significantly decreased, with minimal risk of harm to the patient.
This is a prospective, double-blinded (surgeon and patient) randomized therapeutic trial. Patients will either receive a standard interscalene block with bupivacaine (25 cc of bupivacaine) or will receive similar dosing of liposomal bupivacaine mixed with bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine), which has recently been approved and instituted. These blocks (both) are currently in practice at the study institution and the decision of which to use is currently up to the anesthesiologist. It is current practice that every patient undergoing a rotator cuff surgery is offered a nerve block. Data will be prospectively collected and the data from the experimental group will be compared to the control group at the completion of the study period.
Patents will present for surgery and follow up postoperatively as they would routinely for rotator cuff surgery or shoulder arthroscopy. The anesthesiologist administering the injection will be not be blinded to the mixture of injection (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care.
When discharged home, patients will be asked to keep a log of their narcotic consumption, as well as bringing in their prescription vial to the postoperative follow up and also logging other medications that are consumed during this time period. They will also be asked to log their pain scores in the form of a standardized VAS pain scale form that they will fill out daily until their first follow up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, double-blinded (surgeon and patient) randomized therapeutic trial
| Arm | Type | Receives |
|---|---|---|
| Control- Bupivacaine Alone | Active comparator | Drug: Bupivacaine Injectable Solutionpatients will receive a standard interscalene block with bupivacaine alone (25 cc of bupivacaine) |
| Study- Exparel | Experimental | Drug: Exparel Injectable Solutionpatients will receive an interscalene block with Exparel solution, which is an extended-release formulation of bupivacaine consisting of 10cc liposomal bupivacaine mixed with 15cc bupivacaine. This is approved and used at the study institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients above 18 years of age
- Undergoing rotator cuff surgery or shoulder arthroscopy using an interscalene block
Key exclusion criteria (5 listed)
- Patients with preexisting chronic obstructive pulmonary disease (COPD) or respiratory issues precluding the use of an interscalene block
- Pregnant women, women nursing infants
- Patients with preexisting liver disease
- Patients unwilling to have interscalene block performed
- Patients allergic to bupivacaine, liposomal bupivacaine, or any ingredients contained within the two drugs listed
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 |
|---|---|---|
| Exparel Injectable SolutionPatients randomized to this arm will receive an interscalene block with Exparel solution, an extended-release formulation of bupivacaine (10cc liposomal bupivacaine + 15cc bupivacaine), approved for use at the study institution. This will be administered preoperatively on the day of surgery. The anesthesiologist administering the injection will be not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care. After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count. | Drug | Study- Exparel |
| Bupivacaine Injectable SolutionPatients randomized to this arm will receive a standard interscalene block consisting of 25 cc of bupivacaine alone. This will be administered preoperatively on the day of surgery. The anesthesiologist administering the injection will not be blinded to the mixture of injections (the surgeon and the patient will), which will be designated and randomized prior to administration. They will order and draw up the medication as they have been previously with no change in the standard of care. After surgery, the patient will be asked to keep a daily log of their pain scores, and the amount of narcotics will be counted by the physician at the first postoperative visit. The block would have been offered to the patient even if they are not part of the study. No additional visits are required. The only difference is the journal with pain score surveys and the pill count. | Drug | Control- Bupivacaine Alone |
Primary outcome
Use of pain medications
Time frame: 2 week postoperative visit
Patients will be asked to bring their bottle of pain medication prescribed after surgery to their first office visit so a narcotic pill count can be performed. Patients will record their pain pill consumption every day for 2 weeks in a study journal. The journal containing the pill count will be collected at the 2 week visit in the office. Opioid consumption will be quantified as milligram of opioid equivalents (MME).
1 secondary outcome
Pain severity
Time frame: Every day for the first 2 weeks, and a one-time survey at the 6 week and 12 week visit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 35041742Kim DH, Liu J, Beathe JC, Lin Y, Wetmore DS, Kim SJ, Haskins SC, Garvin S, Oxendine JA, Ho MC, Allen AA, Popovic M, Gbaje E, Wu CL, Memtsoudis SG. Interscalene Brachial Plexus Block with Liposomal Bupivacaine versus Standard Bupivacaine with Perineural Dexamethasone: A Noninferiority Trial. Anesthesiology. 2022 Mar 1;136(3):434-447. doi: 10.1097/ALN.0000000000004111.
- Background: PubMed 28613761Wiederhold BD, Garmon EH, Peterson E, Stevens JB, O'Rourke MC. Nerve Block Anesthesia(Archived). 2023 Apr 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK431109/
- Background: PubMed 25750943Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7.
- Background: PubMed 27673545Vyas KS, Rajendran S, Morrison SD, Shakir A, Mardini S, Lemaine V, Nahabedian MY, Baker SB, Rinker BD, Vasconez HC. Systematic Review of Liposomal Bupivacaine (Exparel) for Postoperative Analgesia. Plast Reconstr Surg. 2016 Oct;138(4):748e-756e. doi: 10.1097/PRS.0000000000002547.
- Background: PubMed 33098008Kaye AD, Armstead-Williams C, Hyatali F, Cox KS, Kaye RJ, Eng LK, Farooq Anwar MA, Patel PV, Patil S, Cornett EM. Exparel for Postoperative Pain Management: a Comprehensive Review. Curr Pain Headache Rep. 2020 Oct 23;24(11):73. doi: 10.1007/s11916-020-00905-4.
- Derived from this study: PubMed 41468585Fedorka CJ, Tornberg HN, Rivera-Pintado C, Gentile PM, Russo D, Boniello M, Hunter K, Desai R, Soni D, Kleiner MT, Dodson G. Liposomal Bupivacaine + Bupivacaine Versus Bupivacaine Interscalene Nerve Block Effect on Pain After Rotator Cuff Repair: A Randomized Control Trial. J Am Acad Orthop Surg. 2026 Aug 15;34(16):e2216-e2225. doi: 10.5435/JAAOS-D-25-01002. Epub 2025 Dec 24.
- 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.
Catherine J Fedorka, MD principal investigator
Cooper Norcross Health
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 Injectable Solution and Bupivacaine Injectable Solution in people with Rotator Cuff Tears and Postoperative Pain, run by Cooper Norcross Health 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 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: finished, as of the sponsor's last update on 5 Nov 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Use of pain medications (time frame: 2 week postoperative visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06139666, which also lists 6 linked publications.
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 Nov 2026.