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

Hughston Clinic

Status and phase: Not yet enrolling; Phase 4

Conditions: Rotator Cuff Tears

Treatments: Drug: Placebo; Drug: Gabapentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05800847

HIRB2022-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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130 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Gabapentin

Experimental group

Description:

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.

Treatment:

Drug: Gabapentin