The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics
| Status: | Suspended |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 72 |
| Updated: | 3/20/2019 |
| Start Date: | September 3, 2015 |
| End Date: | July 2020 |
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.
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.
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.
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
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