Osteoarthritis (OA) of the KneePhase 4NCT06691633
Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA
A Phase 4 study testing Preoperative Methadone and Preoperative Oxycodone in people with Osteoarthritis (OA) of the Knee, run by University of Louisville at 1 site in United States.
Trial summary
The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a… Read more about this study
- Who is it for?
- Ages 21 to 89 years
- Conditions the study is for
- Osteoarthritis (OA) of the Knee
- What is being tested?
- Preoperative Methadone and Preoperative Oxycodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Feb 2024to 18 Oct 2024
- Phase
- Phase 4
- 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 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is 21-89 at time of surgery
- Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Who cannot join
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- History of liver or kidney disease,
- Known or suspected GI obstruction
- Hypersensitivity to methadone
- Patients with significant respiratory depression
- Pregnant or nursing females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study
The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA.
The main questions it aims to answer are:
Read more
- What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty?
- Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty
Participants will:
- be randomized into one of two groups
- undergo a primary TKA
- complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA
- return to office at 2 weeks and 6 weeks postop for follow-up
- complete additional questionnaires at 2 weeks and 6 weeks postop
- Conditions
- Osteoarthritis (OA) of the Knee
- Being tested
- Preoperative Methadone, Preoperative Oxycodone
- Keywords
- osteoarthritis, knee, total knee arthroplasty, prospective RCT, preoperative analgesia, Methadone
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative MethadoneDrug
patient receives a one-time preoperative dose of 10 mg of methadone
Preoperative OxycodoneDrug
patient receives a one-time preoperative dose of 10 mg of oral oxycodone
| Study group | Role | What they receive |
|---|---|---|
| Methadone Group | Experimental | Participant receives a one-time preoperative dose of 10 mg of methadone Receives: Drug: Preoperative Methadone |
| Oxycodone Group | Active comparator | participant receives a one-time preoperative dose of 10 mg of oral oxycodone Receives: Drug: Preoperative Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Opioid Use
Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA
Measured: 2 weeks
Total opioid usage over two weeks
total daily opioid usage (as measured in MME) during the first 14 days following TKA
Measured: 2 weeks
Visual Analogue Scale pain score
Visual Analogue Scale knee pain score (minimum value: 0, maximum value: 10). Higher scores equate to a worse outcome (a score of zero = pain free).
Measured: 2 weeks
Secondary outcomes (5)
Hospital Length of Stay
Number of days patient was an inpatient in the hospital prior to discharge date
Measured: Up to 2 weeks
Discharge location
Whether patient was discharged to home or to a rehab facility
Measured: 2 weeks
Two and six-week narcotic refill
Whether patient was prescribed a two week and/or six-week postoperative narcotic refill
Measured: 6 weeks
Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score
The Knee Injury and Osteoarthritis Outcome Score, Joint Replacement (KOOS, JR.) is a survey measuring overall knee health for individuals post total knee arthroplasty (TKA) by evaluating stiffness, pain, function, and activities of daily living. The minimum value is 0, the maximum value is 100. A higher score means a better outcome.
Measured: preoperatively and 6 weeks (± 2 weeks) postoperatively
ROM
active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion
Measured: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start19 Feb 2024
- Primary completion24 Sep 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized cohort analysis study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arthur Malkani, University of Louisville
- Investigators
- Rodolfo Zamora, MD, Study chair, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691633
- Sponsor's protocol ID
- 23.0752
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Will not share IPD if it is not a requirement
Publications
Ferrari A, Coccia CP, Bertolini A, Sternieri E. Methadone--metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004 Dec;50(6):551-9. doi: 10.1016/j.phrs.2004.05.002.
PubMed 15501692Ebert B, Thorkildsen C, Andersen S, Christrup LL, Hjeds H. Opioid analgesics as noncompetitive N-methyl-D-aspartate (NMDA) antagonists. Biochem Pharmacol. 1998 Sep 1;56(5):553-9. doi: 10.1016/s0006-2952(98)00088-4.
PubMed 9783723Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.
PubMed 19309064Davis AM, Inturrisi CE. d-Methadone blocks morphine tolerance and N-methyl-D-aspartate-induced hyperalgesia. J Pharmacol Exp Ther. 1999 May;289(2):1048-53.
PubMed 10215686Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51. doi: 10.1177/0310057X9202000109.
PubMed 1609941Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
PubMed 19844772Bahreini M, Jalili M, Moradi-Lakeh M. A comparison of three self-report pain scales in adults with acute pain. J Emerg Med. 2015 Jan;48(1):10-8. doi: 10.1016/j.jemermed.2014.07.039. Epub 2014 Sep 27.
PubMed 25271179Aasvang EK, Lunn TH, Hansen TB, Kristensen PW, Solgaard S, Kehlet H. Chronic pre-operative opioid use and acute pain after fast-track total knee arthroplasty. Acta Anaesthesiol Scand. 2016 Apr;60(4):529-36. doi: 10.1111/aas.12667. Epub 2015 Dec 28.
PubMed 26708043
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT06691633
- Acronym / sponsor ID
- 23.0752
- Conditions
- Osteoarthritis (OA) of the Knee
- Keywords
- osteoarthritis, knee, total knee arthroplasty, prospective RCT, preoperative analgesia, Methadone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 24 Sep 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 15 Nov 2024 (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.
The goal of this prospective, randomized study is to compare the outcomes of two cohorts of patients undergoing primary Total Knee Arthroplasty (TKA) and to determine whether a single dose of methadone administered preoperatively is effective at reducing postoperative opioid usage and postoperative pain versus a control group of patients receiving standard intraoperative opioids only for primary TKA.
The main questions it aims to answer are:
- What is the efficacy of a single preoperative dose of methadone in reducing opioid consumption and postoperative pain in primary total knee arthroplasty?
- Will the study results demonstrate the effectiveness and safety of a single preoperative dose of methadone (10 mg) in primary total knee arthroplasty in reducing postoperative opioid usage while maintaining a similar or better level of pain control when compared to a standard pain control regimen? Researchers will compare Methadone to a standard pain control regimen (Oxycodone) to see if Methadone is equivalent or more effective at reducing opioid consumption and postoperative pain in primary total knee arthroplasty
Participants will:
- be randomized into one of two groups
- undergo a primary TKA
- complete a tracking sheet documenting daily pain medicine usage and VAS pain level for the first 14 days following the TKA
- return to office at 2 weeks and 6 weeks postop for follow-up
- complete additional questionnaires at 2 weeks and 6 weeks postop
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized cohort analysis study
| Arm | Type | Receives |
|---|---|---|
| Methadone Group | Experimental | Drug: Preoperative MethadoneParticipant receives a one-time preoperative dose of 10 mg of methadone |
| Oxycodone Group | Active comparator | Drug: Preoperative Oxycodoneparticipant receives a one-time preoperative dose of 10 mg of oral oxycodone |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient age is 21-89 at time of surgery
- Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
- Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
- Patient is able to read and speak English.
Key exclusion criteria (8 listed)
- Patient is under the age of 21
- Patient's primary diagnosis is not osteoarthritis
- Patient is unable to read and speak English
- History of liver or kidney disease,
- Known or suspected GI obstruction
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 |
|---|---|---|
| Preoperative Methadonepatient receives a one-time preoperative dose of 10 mg of methadone | Drug | Methadone Group |
| Preoperative Oxycodonepatient receives a one-time preoperative dose of 10 mg of oral oxycodone | Drug | Oxycodone Group |
Primary outcome
Daily Opioid Use
Time frame: 2 weeks
Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA
Total opioid usage over two weeks
Time frame: 2 weeks
total daily opioid usage (as measured in MME) during the first 14 days following TKA
Visual Analogue Scale pain score
Time frame: 2 weeks
Visual Analogue Scale knee pain score (minimum value: 0, maximum value: 10). Higher scores equate to a worse outcome (a score of zero = pain free).
5 secondary outcomes
Hospital Length of Stay
Time frame: Up to 2 weeks
Discharge location
Time frame: 2 weeks
Two and six-week narcotic refill
Time frame: 6 weeks
Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score
Time frame: preoperatively and 6 weeks (± 2 weeks) postoperatively
ROM
Time frame: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively
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 15 Nov 2024.
- Background: PubMed 15501692Ferrari A, Coccia CP, Bertolini A, Sternieri E. Methadone--metabolism, pharmacokinetics and interactions. Pharmacol Res. 2004 Dec;50(6):551-9. doi: 10.1016/j.phrs.2004.05.002.
- Background: PubMed 9783723Ebert B, Thorkildsen C, Andersen S, Christrup LL, Hjeds H. Opioid analgesics as noncompetitive N-methyl-D-aspartate (NMDA) antagonists. Biochem Pharmacol. 1998 Sep 1;56(5):553-9. doi: 10.1016/s0006-2952(98)00088-4.
- Background: PubMed 19309064Duellman TJ, Gaffigan C, Milbrandt JC, Allan DG. Multi-modal, pre-emptive analgesia decreases the length of hospital stay following total joint arthroplasty. Orthopedics. 2009 Mar;32(3):167.
- Background: PubMed 10215686Davis AM, Inturrisi CE. d-Methadone blocks morphine tolerance and N-methyl-D-aspartate-induced hyperalgesia. J Pharmacol Exp Ther. 1999 May;289(2):1048-53.
- Background: PubMed 1609941Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51. doi: 10.1177/0310057X9202000109.
- Background: PubMed 19844772Bourne RB, Chesworth BM, Davis AM, Mahomed NN, Charron KD. Patient satisfaction after total knee arthroplasty: who is satisfied and who is not? Clin Orthop Relat Res. 2010 Jan;468(1):57-63. doi: 10.1007/s11999-009-1119-9.
- Background: PubMed 25271179Bahreini M, Jalili M, Moradi-Lakeh M. A comparison of three self-report pain scales in adults with acute pain. J Emerg Med. 2015 Jan;48(1):10-8. doi: 10.1016/j.jemermed.2014.07.039. Epub 2014 Sep 27.
- Background: PubMed 26708043Aasvang EK, Lunn TH, Hansen TB, Kristensen PW, Solgaard S, Kehlet H. Chronic pre-operative opioid use and acute pain after fast-track total knee arthroplasty. Acta Anaesthesiol Scand. 2016 Apr;60(4):529-36. doi: 10.1111/aas.12667. Epub 2015 Dec 28.
- Individual participant dataSharing planned: No. Will not share IPD if it is not a requirement
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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.
Rodolfo Zamora, MD study chair
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preoperative Methadone and Preoperative Oxycodone in people with Osteoarthritis (OA) of the Knee, run by University of Louisville 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 4 inclusion and 8 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 15 Nov 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Daily Opioid Use (time frame: 2 weeks). The study lists 3 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 NCT06691633, which also lists 8 linked publications.
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 15 Nov 2024.