SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

NCT04247646 | Active Not Recruiting

• 1 other identifier: 65106563709047
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use; Pain, Postoperative; Sleep; Delirium

Outcome Measures

Primary Outcomes (1)

• Opioid use

  morphine milligram equivalents of opioid medications used by the participant

  Post-operative day 0 through post-operative day 28

Secondary Outcomes (5)

• Pain level

  Post-operative day 0 through post-operative day 28

• Other pain medicine usage

  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

• Sleep fragmentation

  Post-operative day 0 through post-operative day 28

Other Outcomes (5)

• Delirium Incidence

  Post-operative day 0 through hospital discharge

• Change in sleep duration pre and post-operatively

  Post-operative day 0 through post-operative day 28

• Sedation levels

  Post-operative day 0 through post-operative day 28

Study Arms (2)

Melatonin

ACTIVE COMPARATOR

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

Dietary Supplement: Melatonin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Melatonin DIETARY_SUPPLEMENT

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

Melatonin

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scripps Health: lead

Study Sites (1)

Scripps Green Hospital

La Jolla, California, 92037-0001, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Delirium

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Stuti Jaiswal, MD PhD

  Scripps Clinic Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty Hospitalist

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 30, 2020
• Study Start: October 1, 2020
• Primary Completion: March 1, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

US (1)