Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Sleep Disturbance Clinical Trial

Official title:

Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04278677
• Other study ID #: 2020 TJ 02
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 2020
• Est. completion date: March 2021

Study information

• Verified date: February 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: March 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Dietary Supplement:
• melatonin
Melatonin capsules to be taken for 6 weeks

Locations

Country	Name	City	State
United States	Rothman Orthopaedics at Egg Harbor Township	Egg Harbor Township	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pittsburg Sleep Quality Index (PSQI)	PSQI is a validated outcome measure for sleep quality	6 weeks post-surgery