Melatonin Use After Primary Total Joint Arthroplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Knee cohort 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
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
|
| Placebo Comparator: Knee cohort control 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
The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
| Active Comparator: Hip cohort 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
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
|
| Placebo Comparator: Hip cohort control 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
The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
|
Outcome Measures
Primary Outcome Measures
- Change in Sleep Disturbance [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'.
- Change in the quality of sleep [Visit 1 (Screening Visit), Visit 2 (2 months post surgery)]
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.
Secondary Outcome Measures
- Change in quality of hospital length of stay [Visit 1 (Screening Visit), 14 days after surgery visit]
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.
- Change in narcotic consumption patterns [Visit 1 (Screening Visit), 14 days after surgery visit]
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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Joshua C Rozell, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20-02030