Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Status unconfirmed · Not applicable

Conditions studied: Sleep Disturbance

In brief

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.

Key facts

Study ID

NCT04278677

Run by

Rothman Institute Orthopaedics

People needed

80

Starts

2020-03-01

Expected to finish

2021-03-01

Last updated by the study team

2020-02-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who undergo primary ARCR
• Patient willing and able to complete postoperative surveys

You may not qualify if…

• 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

Where it is running

• Rothman Orthopaedics at Egg Harbor Township — Egg Harbor, New Jersey, United States

Full record on ClinicalTrials.gov

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