Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty

• Status: Enrolling by invitation
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether melatonin when used as a supplement after surgery improves sleep following total joint arthroplasty

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rothman Institute Orthopaedics
• Treatments: Melatonin

Criteria

Inclusion Criteria:

1. Patients who undergo unilateral primary total joint arthroplasty

2. Patient willing and able to complete postoperative surveys

Exclusion Criteria:

1. Patients who undergo revision total joint arthroplasty

2. Patients who undergo bilateral total joint arthroplasty

3. Patients currently taking melatonin supplementation

4. Patient has history of substance abuse (drug or alcohol)

5. Patient is a workman's comp patient or patient has current litigation pending

6. Patient has an allergy to melatonin

7. Patient has a history of delirium/psychiatric/depression/on antidepressants

8. Patient has a history of insomnia/ on sleep aid medication

9. Anyone on warfarin

10. Sleep apnea

11. Patient discharged to SNF or rehab

12. Patients who have inflammatory conditions

13. Shift work or night work