← Back to Search

Other

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

Awards & highlights

SLOPE Trial 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.Check my eligibility

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.See study design

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.

SLOPE Trial 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.

SLOPE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative day 0 through post-operative day 28

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid use

Secondary outcome measures

Nightly sleep duration

Analgesics

Pain level

+2 more

Other outcome measures

Change in sleep duration pre and post-operatively

Delirium Incidence

Delirium incidence in those with elevated obstructive sleep apnea risk

+2 more

SLOPE 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Scripps HealthLead Sponsor

54 Previous Clinical Trials

11,672 Total Patients Enrolled

Stuti Jaiswal, MD PhDPrincipal InvestigatorScripps Clinic Medical Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing research study?

"According to the latest information available on clinicaltrials.gov, this particular study is not actively seeking participants. The trial was initially posted on October 1st, 2020 and recently updated on January 22nd, 2024. However, it's worth noting that there are currently a total of 848 other studies accepting patients at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Stuti Jaiswal 2020. "SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04247646.

All > Melatonin