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| Name | Class |
|---|---|
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | 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. |
|
| Gabapentin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | 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. |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brent A Ponce, MD | Contact | 2059306722 | bponce@hughston.com | |
| Cholly Minton | Contact | 7063246661 | cminton@hughston.com |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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| Placebo | Drug | 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. |
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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 |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |