Rotator Cuff Tear
Conditions
Keywords
Shoulder, Rotator cuff
Brief summary
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.
Detailed description
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.
Interventions
DRUGEXPAREL 1.3 % in 20 ML Injection
EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
Sponsors
Pacira Pharmaceuticals, Inc
Andrews Research & Education Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 72 Years
Healthy volunteers
No
Inclusion criteria
* Male or female * 18-72 years of age * Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression by one of the protocol investigators
Exclusion criteria
* Planned concomitant glenoid labral repair * Previous open shoulder surgery * Neurological deficit or other disability involving the surgical extremity * Anyone with a documented allergy to bupivicaine * Subjects that are not mentally competent to give consent * Pregnant women * Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent combination medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Pain Score | 12 hours, 24 hours, 36 hours, 48 hours | Patient reported numeric pain rating using visual analog scale (VAS) (0 = none, 10 = severe) |
| Narcotic Medication Usage | 12 hours, 24 hours, 36 hours, 48 hours, 3 days, 7 days, 14 days | Number of narcotic medication tablets consumed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm | 2 weeks | American Shoulder and Elbow Surgeons Shoulder Score (ASES) of surgical arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function) |
| American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm | 2 weeks | American Shoulder and Elbow Surgeons Shoulder Score (ASES) of healthy (nonsurgical) arm measured utilizing patient reported outcome surveys. (0 = no function; 100 = full function) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EXPAREL 1.3 % in 20 ML Injection 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)
EXPAREL 1.3 % in 20 ML Injection: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | EXPAREL 1.3 % in 20 ML Injection | — |
|---|---|---|
| Age, Customized Age | 56.6 years STANDARD_DEVIATION 6.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 13 participants | — |
| Sex: Female, Male Female | 1 Participants | — |
| Sex: Female, Male Male | 12 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXPAREL 1.3 % in 20 ML Injection | Narcotic Medication Usage | 12 Hours | 1.38 quantity of tablets | Standard Deviation 1.67 |
| EXPAREL 1.3 % in 20 ML Injection | Narcotic Medication Usage | 24 Hours | 1.54 quantity of tablets | Standard Deviation 2.06 |
| EXPAREL 1.3 % in 20 ML Injection | Narcotic Medication Usage | 36 Hours | 1.68 quantity of tablets | Standard Deviation 2.08 |
| EXPAREL 1.3 % in 20 ML Injection | Narcotic Medication Usage | 48 Hours | 1.36 quantity of tablets | Standard Deviation 1.44 |
| EXPAREL 1.3 % in 20 ML Injection | Narcotic Medication Usage | Day 3 | 8.18 quantity of tablets | Standard Deviation 9.75 |
| EXPAREL 1.3 % in 20 ML Injection | Narcotic Medication Usage | Day 7 | 14.42 quantity of tablets | Standard Deviation 16.45 |
| EXPAREL 1.3 % in 20 ML Injection | Narcotic Medication Usage | Day 14 | 18.02 quantity of tablets | Standard Deviation 20.07 |
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| EXPAREL 1.3 % in 20 ML Injection | VAS Pain Score | 12 Hours | 2.7 units on a scale | Standard Deviation 3 |
| EXPAREL 1.3 % in 20 ML Injection | VAS Pain Score | 24 Hours | 3.2 units on a scale | Standard Deviation 3.5 |
| EXPAREL 1.3 % in 20 ML Injection | VAS Pain Score | 36 Hours | 2.3 units on a scale | Standard Deviation 2.7 |
| EXPAREL 1.3 % in 20 ML Injection | VAS Pain Score | 48 Hours | 2.1 units on a scale | Standard Deviation 2.6 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EXPAREL 1.3 % in 20 ML Injection | American Shoulder and Elbow Surgeons Shoulder Score (ASES) of Healthy Arm | 73.6 score on a scale | Standard Deviation 23.7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EXPAREL 1.3 % in 20 ML Injection | American Shoulder and Elbow Surgeons Shoulder Score (ASES) on Surgical Arm | 48.8 score on a scale | Standard Deviation 7 |