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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rotator Cuff Tears
• Intervention / Treatment: Drug: Placebo; Drug: Gabapentin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Brent A Ponce, MD; Phone Number: 2059306722; Email: bponce@hughston.com
• Study Contact Backup: Name: Cholly Minton; Phone Number: 7063246661; Email: cminton@hughston.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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.	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.
Experimental: 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.	Drug: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hughston Clinic
• Collaborators: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2023
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Gabapentin; Opioid Use; Rotator Cuff Repair
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: HIRB2022-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes