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

Rotator Cuff Tears Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05800847
• Other study ID #: HIRB2022-05
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: Hughston Clinic
• Contact: Brent A Ponce, MD
• Phone: 2059306722
• Email: bponce[@]hughston.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hughston Clinic	University of Alabama at Birmingham

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usage of Opioids for Pain Control	Determined based on morphine milligram equivalents	Up to 12 weeks postoperatively
Primary	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	Change in Pain	Determined with Visual Analog Scale (min: 0, max: 10, higher score represents more pain)	Up to 12 weeks postoperatively
Secondary	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
Secondary	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