Opioid UseSLOPENCT04247646
SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty
A study testing Melatonin in people with Opioid Use and Pain, Postoperative, run by Scripps Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Pain, Postoperative, Sleep
- What is being tested?
- Melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults age 18 years and older
- Undergoing elective total knee arthroplasty (single knee)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Green Hospital
La Jolla, California, 92037-0001
About this study
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
- Being tested
- Melatonin, Placebo
- Medical subject headings
- Pain, Postoperative, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDietary supplement
Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.
PlaceboDietary supplement
Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | Melatonin 5 mg sublingual nightly x 29 nights, starting on post-operative day 0. Receives: Dietary Supplement: Melatonin |
| Placebo | Placebo comparator | Placebo troche, sublingual nightly x 29 nights, starting on post-operative day 0. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
morphine milligram equivalents of opioid medications used by the participant
Measured: Post-operative day 0 through post-operative day 28
Secondary outcomes (5)
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).
Measured: Post-operative day 0 through post-operative day 28
Other pain medicine usage
Usage of non-opioid analgesics used by the participant
Measured: Post-operative day 0 through post-operative day 28
Total daily sleep duration
Minutes of sleep obtained daily as measured by actigraphy
Measured: Post-operative day 0 through post-operative day 28
Nightly sleep duration
Minutes of sleep obtained nightly as measured by actigraphy
Measured: Post-operative day 0 through post-operative day 28
Sleep fragmentation
Mean/median length of the sleep bout during nightly sleep
Measured: Post-operative day 0 through post-operative day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Oct 2020
- Primary completion1 Mar 2025 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stuti Jaiswal, Scripps Health
- Investigators
- Stuti Jaiswal, MD PhD, Principal investigator, Scripps Clinic Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247646
- Sponsor's protocol ID
- 65106563709047
- Acronym
- SLOPE
- Status last verified
- Jan 2024
- First submitted
- 27 Jan 2020
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04247646
- Acronym / sponsor ID
- SLOPE / 65106563709047
- Conditions
- Opioid Use, Pain, Postoperative, Sleep, Delirium
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Scripps HealthUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Dietary Supplement: MelatoninMelatonin 5 mg sublingual nightly x 29 nights, starting on post-operative day 0. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo troche, sublingual nightly x 29 nights, starting on post-operative day 0. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age 18 years and older
- Undergoing elective total knee arthroplasty (single knee)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninParticipants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery. | Dietary supplement | Melatonin |
| PlaceboParticipants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery. | Dietary supplement | Placebo |
Primary outcome
Opioid use
Time frame: Post-operative day 0 through post-operative day 28
morphine milligram equivalents of opioid medications used by the participant
5 secondary outcomes
Pain level
Time frame: Post-operative day 0 through post-operative day 28
Other pain medicine usage
Time frame: Post-operative day 0 through post-operative day 28
Total daily sleep duration
Time frame: Post-operative day 0 through post-operative day 28
Nightly sleep duration
Time frame: Post-operative day 0 through post-operative day 28
Sleep fragmentation
Time frame: Post-operative day 0 through post-operative day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stuti Jaiswal, MD PhD principal investigator
Scripps Clinic Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin in people with Opioid Use and Pain, Postoperative, run by Scripps Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid use (time frame: Post-operative day 0 through post-operative day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.