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

NCT05800847 | Unknown Phase 4 FDA Drug

• 1 other identifier: HIRB2022-05
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rotator Cuff Tears

Keywords

Rotator Cuff Repair; Gabapentin; Opioid Use

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Pain

  Up to 12 weeks postoperatively

• Change in Functional Outcome (Based on Prior Baseline)

  Up to 12 weeks postoperatively

• Change in Functional Outcome (Based on Survey)

  Up to 12 weeks postoperatively

Study Arms (2)

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.

Drug: Placebo

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.

Drug: Gabapentin

Interventions

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.

Gabapentin

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair
• between the ages of 18 and 65 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Hughston Clinic: lead
• University of Alabama at Birmingham: collaborator

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Central Study Contacts

Brent A Ponce, MD

CONTACT

2059306722; bponce@hughston.com

Cholly Minton

CONTACT

7063246661; cminton@hughston.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 6, 2023
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share