Melatonin Use After Primary Total Joint Arthroplasty

NYU Langone Health294 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

294

Conditions

Osteo Arthritis Knee

Interventions

Melatonin 5 mgDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 95 Years

Medical Language ↔ Plain English

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)

Locations (1)

NYU Langone Health

New York, New York, United States

Outcomes

Primary Outcomes

Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)

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'.

Time frame: Visit 1 (Screening Visit), Visit 2 (2 months post surgery)

Secondary Outcomes

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score

The PROMIS Sleep Disturbance questionnaire comprises 8 items assessing patients' sleep over the past 7 days. Each item is rated on a Likert scale from 1-5. The raw score is the sum of responses and is transformed to a normalized score from 0-100; higher scores indicate greater sleep disturbance.

Time frame: Visit 1 (Screening Visit), 14 days after surgery visit

Data from ClinicalTrials.gov

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