Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Sleep Disturbance

Treatments: Dietary Supplement: melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT04278677

2020 TJ 02

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Melatonin supplementation

Active Comparator group

Description:

5mg melatonin tablets to be taken for 6 weeks

Treatment:

Dietary Supplement: melatonin

No supplementation

No Intervention group