Status:
UNKNOWN
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
Lead Sponsor:
Rothman Institute Orthopaedics
Conditions:
Sleep Disturbance
Eligibility:
All Genders
18+ years
Phase:
NA
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 rep...
Eligibility Criteria
Inclusion
- Patients who undergo primary ARCR
- Patient willing and able to complete postoperative surveys
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04278677
Start Date
March 1 2020
End Date
March 1 2021
Last Update
February 20 2020
Active Locations (1)
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1
Rothman Orthopaedics at Egg Harbor Township
Egg Harbor, New Jersey, United States, 08234