Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone Group | Experimental | Participant receives a one-time preoperative dose of 10 mg of methadone |
|
| Oxycodone Group | Active Comparator | participant receives a one-time preoperative dose of 10 mg of oral oxycodone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative Methadone | Drug | patient receives a one-time preoperative dose of 10 mg of methadone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Opioid Use | Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA | 2 weeks |
| Total opioid usage over two weeks | total daily opioid usage (as measured in MME) during the first 14 days following TKA | 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). | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Number of days patient was an inpatient in the hospital prior to discharge date | Up to 2 weeks |
| Discharge location | Whether patient was discharged to home or to a rehab facility |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rodolfo Zamora, MD | University of Louisville | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UofL Health | Louisville | Kentucky | 40202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15501692 | Background | 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. | |
| 9783723 | Background | Ebert 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. |
Not provided
Not provided
Will not share IPD if it is not a requirement
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Prospective, randomized cohort analysis study
Not provided
Not provided
Clinical staff other than the anesthesia providers
| Preoperative Oxycodone | Drug | patient receives a one-time preoperative dose of 10 mg of oral oxycodone |
|
| 2 weeks |
| Two and six-week narcotic refill | Whether patient was prescribed a two week and/or six-week postoperative narcotic refill | 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. | preoperatively and 6 weeks (± 2 weeks) postoperatively |
| ROM | active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion | preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively |
| 19309064 | Background | Duellman 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. |
| 10215686 | Background | Davis 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. |
| 1609941 | Background | Chui 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. |
| 19844772 | Background | Bourne 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. |
| 25271179 | Background | Bahreini 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. |
| 26708043 | Background | Aasvang 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. |