Melatonin Use After Primary Total Joint Arthroplasty

Phase 1

Completed

Brief 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.

Detailed 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 & 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)

Arm && Interventions

Group	Intervention	Description
Hip cohort	Melatonin 5 mg	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
Knee cohort	Melatonin 5 mg	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
Knee cohort control	Placebo	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
Hip cohort control	Placebo	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

Primary Outcome Measures

Name	Time	Method
Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)	Visit 1 (Screening Visit), Visit 2 (2 months post surgery)	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'.

Secondary Outcome Measures

Name	Time	Method
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score	Visit 1 (Screening Visit), 14 days after surgery visit	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.