Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gabapentin Following Arthroscopic Rotator Cuff Repair: Evaluation of Postoperative Opioid Use and Sleep Quality

Conditions
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Rotator Cuff Tears

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Patients in this arm will be receiving 100 mg placebo q8h for 2 days followed by 300 mg placebo q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed. | Drug: Placebo<br>* 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.<br>|
| Experimental: Gabapentin<br>Patients in this arm will be receiving 100 mg gabapentin q8h for 2 days followed by 300 mg gabapentin q8h for 12 days. Patients will also receive 30 pills of hydrocodone-acetaminophen 5-325 mg q4-6h as needed. | Drug: Gabapentin<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Usage of Opioids for Pain Control | Determined based on morphine milligram equivalents | Up to 12 weeks postoperatively | 
| Change in Sleep Quality | Determined with Patient-Reported Outcomes Measurement Information System Sleep Disturbance Scale (min: 8, max: 40, higher score represents worse sleep) | Up to 12 weeks postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain | Determined with Visual Analog Scale (min: 0, max: 10, higher score represents more pain) | Up to 12 weeks postoperatively | 
| Change in Functional Outcome (Based on Prior Baseline) | Determined with Single Assessment Numerical Evaluation (min: 0, max: 100, higher score represents better outcome) | Up to 12 weeks postoperatively | 
| Change in Functional Outcome (Based on Survey) | Determined with American Shoulder and Elbow Surgeons Scores (min: 0, max: 100, higher score represents better outcome) | Up to 12 weeks postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Repair, Gabapentin, Opioid Use