Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Not Applicable

• Conditions: Sleep Disturbance

• 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

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-18
• Study First Submitted QC: 2020-02-18
• Last Update Submitted: 2020-02-18
• Study First Posted: 2020-02-20
• Last Update Posted: 2020-02-20
• Study Start: 2020-03
• Primary Completion: 2021-01
• Study Completion: 2021-03

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

Primary Outcome Measures

Name	Time	Method
Pittsburg Sleep Quality Index (PSQI)	6 weeks post-surgery	PSQI is a validated outcome measure for sleep quality

Trial Locations

Locations (1)

Rothman Orthopaedics at Egg Harbor Township; 🇺🇸 Egg Harbor Township, New Jersey, United States