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

NCT ID: NCT05800847

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2024-07-31

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.

Conditions

Rotator Cuff Tears

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Control

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Gabapentin

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.

Group Type: EXPERIMENTAL

Gabapentin

Intervention Type: 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.

Interventions

Gabapentin

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.

Intervention Type: DRUG

Placebo

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

Hughston Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Brent A Ponce, MD

Role: CONTACT

bponce@hughston.com

2059306722

Cholly Minton

Role: CONTACT

cminton@hughston.com

7063246661

Other Identifiers

HIRB2022-05

Identifier Type: -

Identifier Source: org_study_id