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Clinical Trials/NCT04247646
NCT04247646
Active, not recruiting
Not Applicable

SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Scripps Health1 site in 1 country120 target enrollmentOctober 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Use
Sponsor
Scripps Health
Enrollment
120
Locations
1
Primary Endpoint
Opioid use
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2020
End Date
December 31, 2028
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stuti Jaiswal

Faculty Hospitalist

Scripps Health

Eligibility Criteria

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

Outcomes

Primary Outcomes

Opioid use

Time Frame: Post-operative day 0 through post-operative day 28

morphine milligram equivalents of opioid medications used by the participant

Secondary Outcomes

  • Pain level(Post-operative day 0 through post-operative day 28)
  • Sleep fragmentation(Post-operative day 0 through post-operative day 28)
  • Total daily sleep duration(Post-operative day 0 through post-operative day 28)
  • Nightly sleep duration(Post-operative day 0 through post-operative day 28)
  • Other pain medicine usage(Post-operative day 0 through post-operative day 28)

Study Sites (1)

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