Melatonin for Postoperative Pain
(SLOPE Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByStuti Jaiswal, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Scripps Health

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?Prescription opioid misuse and its associated negative effects have become an epidemic in the United States, and post-operative opioid use contributes to this terrible problem. Alternative strategies to opioid prescribing are thus highly sought after in the post-operative setting. Importantly, sleep and pain have a bi-directional relationship, and inadequate or impaired sleep regularly occur following orthopedic operations. Melatonin is an endogenous sleep hormone that can be administered exogenously, and that has been shown to have some potential as an analgesic agent. Here, using the premise that melatonin may improve sleep and pain in the post-operative setting, the investigators propose a randomized clinical trial in 120 participants undergoing total knee arthroplasties. Patients will be randomized to receive either sublingual melatonin 5 mg or matched placebo starting on post-operative day (POD) 0 and through POD . The investigators will measure post-operative opioid usage as the primary outcome, and post-operative pain scores as a secondary outcome. The primary safety outcome will be sedation level, as measured by the Richmond Agitation Sedation Scale (RASS). Sleep will be measured objectively using wrist-worn actigraphy. Participants will be followed through POD 28, and will also have baseline data on sleep, pain, and cognition obtained prior to surgery.

Eligibility Criteria

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.

Inclusion Criteria

I am scheduled for a knee replacement surgery on one knee.

I am 18 years old or older.

Participant Groups

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.

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.

Melatonin is already approved in European Union, European Union, United States for the following indications:

🇪🇺 Approved in European Union as Circadin for: