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Melatonin for Postoperative Pain (SLOPE Trial)

N/A
Waitlist Available
Led By Stuti Jaiswal, MD PhD
Research Sponsored by Scripps Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing elective total knee arthroplasty (single knee)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 0 through post-operative day 28

Summary

This trial is investigating the use of melatonin, a sleep hormone, as a potential alternative to opioids for pain management after knee surgery. The researchers will randomly assign 120 participants to receive either melatonin

Who is the study for?
This trial is for adults over 18 who are having knee replacement surgery. It's not suitable for those undergoing other types of surgeries or treatments.
What is being tested?
The study tests if melatonin can help with sleep and pain after knee surgery, comparing it to a placebo. Patients will take the treatment from the day of surgery until post-operative day 28, tracking opioid use and pain levels.
What are the potential side effects?
Melatonin may cause drowsiness as measured by sedation levels. Other side effects could include changes in mood or alertness, especially when waking up.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a knee replacement surgery on one knee.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 0 through post-operative day 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 0 through post-operative day 28 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid use
Secondary study objectives
Nightly sleep duration
Analgesics
Pain level
+2 more
Other study objectives
Change in sleep duration pre and post-operatively
Delirium Incidence
Delirium incidence in those with elevated obstructive sleep apnea risk
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MelatoninActive Control1 Intervention
Melatonin 5 mg sublingual nightly x 29 nights, starting on post-operative day 0.
Group II: PlaceboPlacebo Group1 Intervention
Placebo troche, sublingual nightly x 29 nights, starting on post-operative day 0.

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Who is running the clinical trial?

Scripps HealthLead Sponsor
58 Previous Clinical Trials
43,453 Total Patients Enrolled
Stuti Jaiswal, MD PhDPrincipal InvestigatorScripps Clinic Medical Group
~5 spots leftby Mar 2025
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