Postoperative Pain, Rotator Cuff Tears
Conditions
Brief 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. 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.
Interventions
DRUGLiposomal bupivacaine
20 mL Liposomal bupivacaine (Exparel) will be given in the shoulder block prior to surgery
0.75% bupivacaine will be given in the shoulder block prior to surgery
DRUGDexamethasone
10 mg Dexamethasone will be given in the shoulder block prior to surgery
Sponsors
Rothman Institute Orthopaedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative narcotic medication use | 14 days | Participants will be asked to record the amount of medication they take to control pain after surgery |
| Postoperative pain levels | 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 |
Countries
United States
Outcome results
None listed