SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Not Applicable

Active, not recruiting

• Conditions: Sleep; Opioid Use; Pain, Postoperative; Delirium
• Interventions: Dietary Supplement: Melatonin; Dietary Supplement: Placebo

• Registration Number: NCT04247646
• Lead Sponsor: Scripps Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-27
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-30
• Study Start: 2020-10-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-24
• Primary Completion: 2025-03-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Melatonin	Melatonin	Melatonin 5 mg sublingual nightly x 29 nights, starting on post-operative day 0.
Placebo	Placebo	Placebo troche, sublingual nightly x 29 nights, starting on post-operative day 0.

Primary Outcome Measures

Name	Time	Method
Opioid use	Post-operative day 0 through post-operative day 28	morphine milligram equivalents of opioid medications used by the participant

Secondary Outcome Measures

Name	Time	Method
Pain level	Post-operative day 0 through post-operative day 28	Numerical pain scores reported by the patient following surgery using the Visual Analog Scale (Scale of 0-10, with 0 being no pain and 10 being the worst possible pain).
Sleep fragmentation	Post-operative day 0 through post-operative day 28	Mean/median length of the sleep bout during nightly sleep
Total daily sleep duration	Post-operative day 0 through post-operative day 28	Minutes of sleep obtained daily as measured by actigraphy
Nightly sleep duration	Post-operative day 0 through post-operative day 28	Minutes of sleep obtained nightly as measured by actigraphy
Other pain medicine usage	Post-operative day 0 through post-operative day 28	Usage of non-opioid analgesics used by the participant

Trial Locations

Locations (1)

Scripps Green Hospital; 🇺🇸 La Jolla, California, United States