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Active, Not Recruiting

NCT Number: NCT04247646

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Green Hospital

La Jolla, California, 92037-0001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

melatonin

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Pain level

    Time frame: 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).

  2. Other pain medicine usage

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

    Usage of non-opioid analgesics used by the participant

  3. Total daily sleep duration

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

    Minutes of sleep obtained daily as measured by actigraphy

  4. Nightly sleep duration

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

    Minutes of sleep obtained nightly as measured by actigraphy

  5. Sleep fragmentation

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

    Mean/median length of the sleep bout during nightly sleep

Other outcomes

  1. Delirium Incidence

    Time frame: Post-operative day 0 through hospital discharge

    Rates of inpatient delirium as measured by the Confusion Assessment Method

  2. Change in sleep duration pre and post-operatively

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

    change in sleep duration (minutes) following surgery, using pre-operative sleep data as the comparator

  3. Sedation levels

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

    Sedation levels, as measured by the Richmond Agitation Sedation Scale (RASS), during inpatient stay. RASS scores are measured on a scale of -5 to +5 with -5 equating to deeply sedated (deep coma) and +5 equating to extremely agitated/combative.

  4. Subjective sleep

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

    subjective sleep scores as measured by the Richards Campbell Sleep Questionnaire while inpatient. The Richards Campbell Sleep Questionnaire is a 5-item questionnaire scored on a visual, 100 milimeter scale where the participants marks or selects where they fell on the scale in response to the specific question. Scores are assigned from 0-100 based on where the participant's response lies, with a higher score indicating better sleep.

  5. Delirium incidence in those with elevated obstructive sleep apnea risk

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

    Delirium incidence in those with elevated OSA risk, based on the Berlin and STOP-BANG criteria

Sponsors and collaborators

Lead sponsor

Scripps Health

Other

Registry information

Acronym: SLOPE

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Jan 30, 2020
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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