Clinical trial NCT04247646: SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty
Official title: SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use
Pain, Postoperative
Sleep
Delirium
Lead sponsor: Scripps Health
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Opioid use
timeFrame: Post-operative day 0 through post-operative day 28
Secondary outcomes:
measure: Pain level
timeFrame: Post-operative day 0 through post-operative day 28
measure: Other pain medicine usage
timeFrame: Post-operative day 0 through post-operative day 28
measure: Total daily sleep duration
timeFrame: Post-operative day 0 through post-operative day 28
measure: Nightly sleep duration
timeFrame: Post-operative day 0 through post-operative day 28
measure: Sleep fragmentation
timeFrame: Post-operative day 0 through post-operative day 28
Other outcomes:
measure: Delirium Incidence
timeFrame: Post-operative day 0 through hospital discharge
measure: Change in sleep duration pre and post-operatively
timeFrame: Post-operative day 0 through post-operative day 28
measure: Sedation levels
timeFrame: Post-operative day 0 through post-operative day 28
measure: Subjective sleep
timeFrame: Post-operative day 0 through post-operative day 28
measure: Delirium incidence in those with elevated obstructive sleep apnea risk
timeFrame: Post-operative day 0 through post-operative day 28
Locations:
city: La Jolla
country: United States
facility: Scripps Green Hospital
state: California
Study officials:
affiliation: Scripps Clinic Medical Group
name: Stuti Jaiswal, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: