Rotator Cuff Tears
Conditions
Keywords
Rotator Cuff Repair, Gabapentin, Opioid Use
Brief summary
The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.
Detailed description
Perioperative gabapentin use has been established in prior literature to decrease postoperative opioid use; however, all of these studies have evaluated gabapentin given by an anesthesia team in the immediate pre- or intraoperative period. No known literature exists regarding scheduled post-operative oral gabapentin use in regards to pain control and opioid use. Sleep quality still tends to be a frequent concern associated with rotator cuff injury and shoulder surgery in general. The added known benefit of somnolence or drowsiness, in addition to aid in sleep, with use of gabapentin may also contribute to improved sleep quality following rotator cuff repair.
Interventions
DRUGGabapentin
Gabapentin will be administered for 2 days at 100 mg q8h for titration to avoid side effects. The next 12 days, gabapentin will be taken at 300 mg q8h.
DRUGPlacebo
Placebo will follow the same dosing pattern as gabapentin to allow for blinding. Placebo will be encapsulated with a gelatin capsule to mimic the look of gabapentin.
Sponsors
University of Alabama at Birmingham
Hughston Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair * between the ages of 18 and 65 years old
Exclusion criteria
* chronic pre-operative narcotic pain medication use * undergoing superior capsular reconstruction / balloon interposition etc * \< 18 y/o or \> 65 y/o * bilateral rotator cuff tear * currently taking prescribed sleep-aid medications * history of fibromyalgia or chronic pain syndrome * pain management patient * narcolepsy diagnosis * diagnosis of cervical radiculopathy * reported non-shoulder pain interfering with sleep
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Usage of Opioids for Pain Control | Up to 12 weeks postoperatively | Determined based on morphine milligram equivalents |
| Change in Sleep Quality | Up to 12 weeks postoperatively | Determined with Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (min: 8, max: 40, higher score represents worse sleep) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain | Up to 12 weeks postoperatively | Determined with Visual Analog Scale (min: 0, max: 10, higher score represents more pain) |
| Change in Functional Outcome (Based on Prior Baseline) | Up to 12 weeks postoperatively | Determined with Single Assessment Numerical Evaluation (min: 0, max: 100, higher score represents better outcome) |
| Change in Functional Outcome (Based on Survey) | Up to 12 weeks postoperatively | Determined with American Shoulder and Elbow Surgeons Scores (min: 0, max: 100, higher score represents better outcome) |
Contacts
Primary ContactBrent A Ponce, MD
Backup ContactCholly Minton
Outcome results
None listed