Melatonin Use After Primary Total Joint Arthroplasty

Osteo Arthritis Knee Clinical Trial

Official title:

Melatonin Use After Primary Total Joint Arthroplasty: A Randomized, Double Blind Placebo-Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04795336
• Other study ID #: 20-02030
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Daniel Warren
• Phone: 212-598-6245
• Email: Daniel.waren[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.

Description:

This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: June 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• Patient are current candidates for elective primary total hip and total knee arthroplasty.

• Patients =18 years of age but = 95

• Patients have been medically cleared and scheduled for surgery

Exclusion Criteria:

• Non-elective conversion arthroplasty

• Bilateral total joint arthroplasty

• Contraindications to use of melatonin (diabetes, calcium channel blocker use, depression)

• Conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids)

• Conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)

Related Conditions & MeSH terms

• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Melatonin 5 mg
Melatonin is a widely sold synthetic molecule in various forms including tablets, gummies and liquid. In the present study, the tablet version of the medication will be used at a dose of 5mg

Other:
• Placebo
The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Sleep Disturbance	The primary objective is the Epworth Sleep Score used to evaluate the impact of melatonin use on the quality of sleep, including total hours of sleep and nighttime awakenings in patients undergoing elective primary total hip and knee arthroplasty.The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.	Visit 1 (Screening Visit), Visit 2 (2 months post surgery)
Primary	Change in the quality of sleep	Measured by the patient reported survey on quality of sleep. Stanford Sleepiness Scale (SSS) uses a 7-point Likert scale to quantify a patient's sleepiness at the time the questionnaire is completed.	Visit 1 (Screening Visit), Visit 2 (2 months post surgery)
Secondary	Change in quality of hospital length of stay	To investigate hospital length of stay in patients who take melatonin as a sleep aid for 14 days after surgery. Measured by patient reported outcome questionnaires.	Visit 1 (Screening Visit), 14 days after surgery visit
Secondary	Change in narcotic consumption patterns	Narcotic consumption patterns in patients who take melatonin as a sleep aid for 14 days after surgery. Opioid consumption will be measured based on in-patient pain medications given following surgery.	Visit 1 (Screening Visit), 14 days after surgery visit