Osteo Arthritis KneeNCT04003350
The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
A study testing Oxycodone, Tramadol and Tylenol in people with Osteo Arthritis Knee, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Oxycodone, Tramadol and Tylenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2017to 15 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
- ASA I - III
- Spinal anesthesia
- All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases
- Male and Female over 18 who are willing and able to provide informed consent
Who cannot join
- Opioid use within 3 months preoperatively
- Inability to take the protocol medications
- Anticoagulant other than aspirin
- Contraindication to regional anesthesia
- Non-english speaking
- ASA IV or greater
Show all 11Show fewer
- Psychiatric or cognitive disorders
- Allergy/contraindications to protocol medications.
- Renal insufficiency with Cr > 2.0 or hepatic failure
- General anesthesia
- Sensory/motor disorder involving the operative limb
Trial locations and contacts
1 site in 1 country.
About this study
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.
PURPOSE:
- To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects.
- To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Oxycodone, Tramadol, Tylenol, Meloxicam, Gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)
TramadolDrug
Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)
TylenolDrug
Tylenol 1000 mg: take as needed every 8 hours
MeloxicamDrug
Meloxicam 15 mg as need once per day
GabapentinDrug
•Gabapentin 200 mg with morning and evening Tylenol dose
MetaxaloneDrug
Metaxalone 800mg TID
Esomeprazole 20mgDrug
Esomeprazole 20mg daily
| Study group | Role | What they receive |
|---|---|---|
| Opioid Regimen | Active comparator | Weeks 1-4
* Oxycodone 5 mg PRN q4h (30 tablets)
* Tramadol 50 mg PRN q6h (30 tablets) Receives: Drug: Oxycodone; Drug: Tramadol |
| Multimodal pain regimen with PRN opioids | Experimental | Weeks 1-4
* Tylenol 1000 mg q8h (standing)
* Meloxicam 15 mg qD (standing).
* Gabapentin 200 mg BID (with morning and evening Tylenol dose)
* Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone)
* Esomeprazole 20mg daily if not already on another H2 blocker or PPI
* Oxycodone 5 mg PRN q4h (30 tablets)
* Tramadol 50 mg PRN q6h (30 tablets) Receives: Drug: Oxycodone; Drug: Tramadol; Drug: Tylenol; Drug: Meloxicam; Drug: Gabapentin; Drug: Metaxalone; Drug: Esomeprazole 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Measured via Visual Analog scale (0-100mm)
Measured: Postsurgery days 1-30
Opioid related side effects
Severity measured via Visual Analog scale (0-100mm)
Measured: post-surgery days 1-30
Secondary outcomes (4)
opioid consumption
morphine milligram equivalent
Measured: post-surgery weeks 1-4
opioid consumption
number of pills consumed
Measured: post-surgery weeks 1-4
number of opioid refills
number of times subjects asked to have an opioid prescription refilled during post-operative period
Measured: post-surgery weeks 1-4
90 day complications
collection of all post-operative medical complications within the first 90 days after surgery
Measured: post-surgery 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start21 Dec 2017
- Primary completion26 Nov 2018
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003350
- Sponsor's protocol ID
- 2019MAUSTKA
- Status last verified
- Jun 2019
- First submitted
- 21 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li WT, Bell KL, Yayac M, Barmann JA, Star AM, Austin MS. A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial. J Arthroplasty. 2021 Jan;36(1):164-172.e2. doi: 10.1016/j.arth.2020.07.060. Epub 2020 Jul 30.
PubMed 33036845
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04003350
- Acronym / sponsor ID
- 2019MAUSTKA
- Conditions
- Osteo Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 26 Nov 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 1 Jul 2019 (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.
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.
PURPOSE:
- To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects.
- To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid Regimen | Active comparator | Drug: Oxycodone, Drug: TramadolWeeks 1-4 * Oxycodone 5 mg PRN q4h (30 tablets) * Tramadol 50 mg PRN q6h (30 tablets) |
| Multimodal pain regimen with PRN opioids | Experimental | Drug: Oxycodone, Drug: Tramadol, Drug: Tylenol, Drug: Meloxicam, Drug: Gabapentin, Drug: Metaxalone, Drug: Esomeprazole 20mgWeeks 1-4 * Tylenol 1000 mg q8h (standing) * Meloxicam 15 mg qD (standing). * Gabapentin 200 mg BID (with morning and evening Tylenol dose) * Metaxalone 800mg PO TID (Tizanidine 2mg q8h if insurance coverage is not possible for metaxalone) * Esomeprazole 20mg daily if not already on another H2 blocker or PPI * Oxycodone 5 mg PRN q4h (30 tablets) * Tramadol 50 mg PRN q6h (30 tablets) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
- ASA I - III
- Spinal anesthesia
- All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases
- Male and Female over 18 who are willing and able to provide informed consent
Key exclusion criteria (11 listed)
- Opioid use within 3 months preoperatively
- Inability to take the protocol medications
- Anticoagulant other than aspirin
- Contraindication to regional anesthesia
- Non-english speaking
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 |
|---|---|---|
| OxycodonePatients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets) | Drug | Multimodal pain regimen with PRN opioids, Opioid Regimen |
| TramadolPatients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets) | Drug | Multimodal pain regimen with PRN opioids, Opioid Regimen |
| TylenolTylenol 1000 mg: take as needed every 8 hours | Drug | Multimodal pain regimen with PRN opioids |
| MeloxicamMeloxicam 15 mg as need once per day | Drug | Multimodal pain regimen with PRN opioids |
| Gabapentin•Gabapentin 200 mg with morning and evening Tylenol dose | Drug | Multimodal pain regimen with PRN opioids |
| MetaxaloneMetaxalone 800mg TID | Drug | Multimodal pain regimen with PRN opioids |
| Esomeprazole 20mgEsomeprazole 20mg daily | Drug | Multimodal pain regimen with PRN opioids |
Primary outcome
Post-operative pain
Time frame: Postsurgery days 1-30
Measured via Visual Analog scale (0-100mm)
Opioid related side effects
Time frame: post-surgery days 1-30
Severity measured via Visual Analog scale (0-100mm)
4 secondary outcomes
opioid consumption
Time frame: post-surgery weeks 1-4
opioid consumption
Time frame: post-surgery weeks 1-4
number of opioid refills
Time frame: post-surgery weeks 1-4
90 day complications
Time frame: post-surgery 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Derived from this study: PubMed 33036845Li WT, Bell KL, Yayac M, Barmann JA, Star AM, Austin MS. A Postdischarge Multimodal Pain Management Cocktail Following Total Knee Arthroplasty Reduces Opioid Consumption in the 30-Day Postoperative Period: A Group-Randomized Trial. J Arthroplasty. 2021 Jan;36(1):164-172.e2. doi: 10.1016/j.arth.2020.07.060. Epub 2020 Jul 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxycodone, Tramadol and Tylenol in people with Osteo Arthritis Knee, run by Rothman Institute Orthopaedics 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 1 Jul 2019. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-operative pain (time frame: Postsurgery days 1-30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04003350, which also lists 1 linked publication.
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 1 Jul 2019.