Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Not Applicable
- Conditions
- Sleep Disturbance
- Interventions
- Dietary Supplement: melatonin
- Registration Number
- NCT04278677
- Lead Sponsor
- Rothman Institute Orthopaedics
- Brief Summary
The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Patients who undergo primary ARCR
- Patient willing and able to complete postoperative surveys
Exclusion Criteria
- Daily melatonin use for > 1 week during the last 3 months
- Irreparable tears
- Revision rotator cuff repairs
- Severe glenohumeral arthritis
- Concurrent adhesive capsulitis
- Age less than 18
- Pregnancy
- History of substance abuse (drug or alcohol)
- Workman's comp patient or patient has current litigation pending
- Allergy to melatonin
- History of delirium/psychiatric/depression/ on antidepressants
- History of insomnia/ on sleep aid medication
- Use of prescription sedatives
- use of Zelboraf (vemurafenib)
- Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
- Sleep apnea
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Melatonin supplementation melatonin 5mg melatonin tablets to be taken for 6 weeks
- Primary Outcome Measures
Name Time Method Pittsburg Sleep Quality Index (PSQI) 6 weeks post-surgery PSQI is a validated outcome measure for sleep quality
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Rothman Orthopaedics at Egg Harbor Township
🇺🇸Egg Harbor Township, New Jersey, United States