Melatonin Use After Primary Total Joint Arthroplasty

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Drug: Melatonin 5 mg
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Knee cohort<br>In 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 recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days | Drug: Melatonin 5 mg<br>* 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<br>|
| Placebo Comparator: Knee cohort control<br>In 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 recruited into placebo group. Control group will receive a placebo pill for 14 days | Other: Placebo<br>* The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.<br>|
| Active Comparator: Hip cohort<br>In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days | Drug: Melatonin 5 mg<br>* 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<br>|
| Placebo Comparator: Hip cohort control<br>In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days | Other: Placebo<br>* The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |