SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Pain, Postoperative Clinical Trial

— SLOPE  

Official title:

SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04247646
• Other study ID #: 65106563709047
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Scripps Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: December 31, 2028
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Opioid Use
• Pain, Postoperative
• Sleep

Intervention

Dietary Supplement:
• Melatonin
Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.
• Placebo
Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.

Locations

Country	Name	City	State
United States	Scripps Green Hospital	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Delirium Incidence	Rates of inpatient delirium as measured by the Confusion Assessment Method	Post-operative day 0 through hospital discharge
Other	Change in sleep duration pre and post-operatively	change in sleep duration (minutes) following surgery, using pre-operative sleep data as the comparator	Post-operative day 0 through post-operative day 28
Other	Sedation levels	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.	Post-operative day 0 through post-operative day 28
Other	Subjective sleep	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.	Post-operative day 0 through post-operative day 28
Other	Delirium incidence in those with elevated obstructive sleep apnea risk	Delirium incidence in those with elevated OSA risk, based on the Berlin and STOP-BANG criteria	Post-operative day 0 through post-operative day 28
Primary	Opioid use	morphine milligram equivalents of opioid medications used by the participant	Post-operative day 0 through post-operative day 28
Secondary	Pain level	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).	Post-operative day 0 through post-operative day 28
Secondary	Other pain medicine usage	Usage of non-opioid analgesics used by the participant	Post-operative day 0 through post-operative day 28
Secondary	Total daily sleep duration	Minutes of sleep obtained daily as measured by actigraphy	Post-operative day 0 through post-operative day 28
Secondary	Nightly sleep duration	Minutes of sleep obtained nightly as measured by actigraphy	Post-operative day 0 through post-operative day 28
Secondary	Sleep fragmentation	Mean/median length of the sleep bout during nightly sleep	Post-operative day 0 through post-operative day 28