Delirium, Opioid Use, Pain, Postoperative, Sleep
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMelatonin
Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.
DIETARY_SUPPLEMENTPlacebo
Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.
Sponsors
Scripps Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid use | Post-operative day 0 through post-operative day 28 | morphine milligram equivalents of opioid medications used by the participant |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| Other pain medicine usage | Post-operative day 0 through post-operative day 28 | Usage of non-opioid analgesics used by the participant |
| 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 |
| Sleep fragmentation | Post-operative day 0 through post-operative day 28 | Mean/median length of the sleep bout during nightly sleep |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in sleep duration pre and post-operatively | Post-operative day 0 through post-operative day 28 | change in sleep duration (minutes) following surgery, using pre-operative sleep data as the comparator |
| Sedation levels | 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. |
| Subjective sleep | 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. |
| Delirium incidence in those with elevated obstructive sleep apnea risk | 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 |
| Delirium Incidence | Post-operative day 0 through hospital discharge | Rates of inpatient delirium as measured by the Confusion Assessment Method |
Countries
United States
Outcome results
None listed