SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2028-12-31

Brief Summary

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Prescription opioid misuse and its associated negative effects have become an epidemic in the United States, and post-operative opioid use contributes to this terrible problem. Alternative strategies to opioid prescribing are thus highly sought after in the post-operative setting. Importantly, sleep and pain have a bi-directional relationship, and inadequate or impaired sleep regularly occur following orthopedic operations. Melatonin is an endogenous sleep hormone that can be administered exogenously, and that has been shown to have some potential as an analgesic agent. Here, using the premise that melatonin may improve sleep and pain in the post-operative setting, the investigators propose a randomized clinical trial in 120 participants undergoing total knee arthroplasties. Patients will be randomized to receive either sublingual melatonin 5 mg or matched placebo starting on post-operative day (POD) 0 and through POD . The investigators will measure post-operative opioid usage as the primary outcome, and post-operative pain scores as a secondary outcome. The primary safety outcome will be sedation level, as measured by the Richmond Agitation Sedation Scale (RASS). Sleep will be measured objectively using wrist-worn actigraphy. Participants will be followed through POD 28, and will also have baseline data on sleep, pain, and cognition obtained prior to surgery.

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Detailed Description

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Conditions

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Opioid Use Pain, Postoperative Sleep Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Melatonin

Melatonin 5 mg sublingual nightly x 29 nights, starting on post-operative day 0.

Group Type ACTIVE_COMPARATOR

Melatonin

Intervention Type DIETARY_SUPPLEMENT

Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.

Placebo

Placebo troche, sublingual nightly x 29 nights, starting on post-operative day 0.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.

Interventions

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Melatonin

Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Adults age 18 years and older
* Undergoing elective total knee arthroplasty (single knee)

Exclusion Criteria

* Non-English speakers
* Individuals with dementia
* Patients with liver cirrhosis
* Patients currently taking prescription sleep aids
* Patients with long-term (greater than 3 months prior to surgery), chronic opioid use

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No