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NCT04247646 · ClinicalTrials.gov registry record · NA
SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty
A NA study of Sleep and Pain, Postoperative, sponsored by Scripps Health.
- Active
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04247646 is a NA study of Sleep and Pain, Postoperative that is active but no longer recruiting, run by Scripps Health. The registered enrollment target is 120 participants, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04247646, a NA study of Sleep and Pain, Postoperative, is active but no longer recruiting, sponsored by Scripps Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Melatonin
Study Locations (1)
California
- Scripps Green Hospital - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2028-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04247646
The ClinicalTrials.gov registry entry for NCT04247646 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,165-participant average among 151 other Sleep trials with a reported enrollment target (97% lower). The listed sponsor is Scripps Health, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04247646 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04247646 about?
NCT04247646 is a clinical study titled "SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty". 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...
What is the current status of trial NCT04247646?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2020-10-01. Estimated completion is 2028-12-31.
What conditions does trial NCT04247646 study?
This clinical trial studies the following conditions: Sleep, Pain, Postoperative, Opioid Use, Delirium.
What interventions are being tested in trial NCT04247646?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Melatonin (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04247646?
This trial is sponsored by Scripps Health, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04247646 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.