A Phase 4 interventional study of EXPAREL 1.3 % in 20 ML Injection in Rotator Cuff Tear, sponsored by Andrews Research & Education Foundation. Terminated at 1 site in United States. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Andrews Research & Education Foundation · Phase 4, Interventional, and Treatment
Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of this study. The purpose of this study is to determine if the product EXPAREL® can be used as a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and providing appropriate postoperative pain control.
Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient setting. Conducting this study, will allow the option for a surgeon to administer a local anesthetic, in a single injection, to the exact location of the surgical procedure and in a sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used as a safe alternative to current post-operative pain control methods, while limiting narcotic use and providing appropriate postoperative analgesia.
631 studies on the registry are indexed under Rotator Cuff Injuries; 156 are open to participants now.
This study's enrollment of 13 is below the median of 60 across 456 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →Andrews Research & Education Foundation is the lead sponsor of 20 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% \[13.3 mg/mL\]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors: * size of surgical site * volume required to cover the area * individual patient factors that may impact the safety of an amide local anesthetic * maximum doe of 266 mg (20 mL)
Drug: EXPAREL 1.3 % in 20 ML Injection
EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
Also known as: bupivacaine liposome injectable suspension
VAS Pain Score
Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe)
Time frame: 12 hours, 24 hours, 36 hours, 48 hours
Narcotic Medication Usage
Number of narcotic medication tablets consumed
Time frame: 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days
American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
Time frame: 2 weeks
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
Time frame: 2 weeks
| Milestone | EXPAREL 1.3 % in 20 ML Injection |
|---|---|
| Started | 13 |
| Completed | 13 |
| Not completed | 0 |
Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe)
| units on a scale | EXPAREL 1.3 % in 20 ML Injection |
|---|---|
| 12 Hours | 2.7 ± 3.0 |
| 24 Hours | 3.2 ± 3.5 |
| 36 Hours | 2.3 ± 2.7 |
| 48 Hours | 2.1 ± 2.6 |
Number of narcotic medication tablets consumed
| quantity of tablets | EXPAREL 1.3 % in 20 ML Injection |
|---|---|
| 12 Hours | 1.38 ± 1.67 |
| 24 Hours | 1.54 ± 2.06 |
| 36 Hours | 1.68 ± 2.08 |
| 48 Hours | 1.36 ± 1.44 |
| Day 3 | 8.18 ± 9.75 |
| Day 7 | 14.42 ± 16.45 |
| Day 14 | 18.02 ± 20.07 |
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
| score on a scale | EXPAREL 1.3 % in 20 ML Injection |
|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm | 48.8 ± 7 |
American Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function)
| score on a scale | Healthy Arm |
|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm | 73.6 ± 23.7 |
Collected over 10 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| EXPAREL 1.3 % in 20 ML Injection | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Customized(years) | EXPAREL 1.3 % in 20 ML Injection |
|---|---|
| Age | 56.6 ± 6.4 |
| Sex: Female, Male(Participants) | EXPAREL 1.3 % in 20 ML Injection |
|---|---|
| Female | 1 |
| Male | 12 |
| Race and Ethnicity Not Collected(Participants) | EXPAREL 1.3 % in 20 ML Injection |
|---|
| Region of Enrollment(participants) | EXPAREL 1.3 % in 20 ML Injection |
|---|---|
| United States | 13 |
Plan to share: No
Ran from Sep 2015 to primary completion in Dec 2016, 15 months.
Results were first posted in Mar 2025, 8 years 3 months after primary completion.
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This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Liposomal Bupivacaine
Andrews Research & Education Foundation