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The goal of this study is to determine whether one dose of IV methadone given right before surgery will help patients' pain management after a total knee replacement and reduce the amount of pain medications taken in the weeks after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone | Experimental | Patient will receive one perioperative dose of IV methadone prior to their surgical procedure in addition to standard of care medications. |
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| No medication | No Intervention | Patient will receive only the standard of care medications for their procedure. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Subjects randomized to receive methadone will be given one dose of methadone 0.15mg/kg intravenously dosed based on ideal body weight administered by the anesthesia team prior to surgical incision |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid use for 48 hours post-operatively | Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption. | 48 hours after TKA procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Defense and Veterans Pain Scale | Using the Defense and Veterans Pain Scale, patients will rate their pain ranging from 0 (no pain) to 10 (severe pain) | 2 weeks after TKA procedure |
| Opioid-Related Symptom Distress Scale (ORSDS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Makenna Hemmerle | Contact | 303-260-2951 | makenna.hemmerle@adventhealth.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AdventHealth Porter | Recruiting | Denver | Colorado | 80210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21173206 | Background | Kharasch ED. Intraoperative methadone: rediscovery, reappraisal, and reinvigoration? Anesth Analg. 2011 Jan;112(1):13-6. doi: 10.1213/ANE.0b013e3181fec9a3. No abstract available. | |
| 29847382 | Background | Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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Research staff
4-point scale that evaluates 12 symptoms in 3 symptom categories including frequency, severity, and bothersomeness. The ORSDS may be used to calculate a symptom-specific score, which is the average of the 3 symptom distress dimensions and range from 0 to 4. The composite ORSDS score is the mean of all 12 symptom-specific scores. Composite ORSDS scores range from 0 to 4.
| At baseline and 2 weeks after TKA procedure |
| Pittsburgh Sleep Quality Index | Patients will complete survey to monitor sleeping habits | At baseline and 2 weeks after TKA procedure |
| Total opioid usage over 2 weeks post-operatively | Opioid use will be calculated using morphine milligram equivalents (MME). Patients will keep a log to track opioid consumption. | 2 weeks after TKA procedure |
| Knee Society Score | This survey includes alignment, instability, joint range of motion, and symptoms. A higher score indicates good alignment, range of motion, and minimal symptoms of pain. A lower score indicates poor knee alignment, potential issues in range of motion, and the likely experience of symptoms of pain. | At baseline |
| KOOS-12 Knee Survey | This survey is used to evaluate knee pain, function and quality of life. The total score ranges from 0 to 100, where higher scores indicate better outcomes. | At baseline |
| Veterans Rand 12-Item Health Survey (VR-12) | This survey assesses overall health-related quality of life across physical and mental domains. It generates two summary scores-Physical Component Summary (PCS) and Mental Component Summary (MCS)-to provide a standardized evaluation of a patient's functional health and well-being. | At baseline |
| 37638083 | Background | Friesgaard KD, Brix LD, Kristensen CB, Rian O, Nikolajsen L. Clinical effectiveness and safety of intraoperative methadone in patients undergoing laparoscopic hysterectomy: a randomised, blinded clinical trial. BJA Open. 2023 Aug 5;7:100219. doi: 10.1016/j.bjao.2023.100219. eCollection 2023 Sep. |
| 25911660 | Background | Morris BJ, Mir HR. The opioid epidemic: impact on orthopaedic surgery. J Am Acad Orthop Surg. 2015 May;23(5):267-71. doi: 10.5435/JAAOS-D-14-00163. |
| 25694266 | Background | Menendez ME, Ring D, Bateman BT. Preoperative Opioid Misuse is Associated With Increased Morbidity and Mortality After Elective Orthopaedic Surgery. Clin Orthop Relat Res. 2015 Jul;473(7):2402-12. doi: 10.1007/s11999-015-4173-5. Epub 2015 Feb 19. |
| 28887020 | Background | Cancienne JM, Patel KJ, Browne JA, Werner BC. Narcotic Use and Total Knee Arthroplasty. J Arthroplasty. 2018 Jan;33(1):113-118. doi: 10.1016/j.arth.2017.08.006. Epub 2017 Aug 17. |
| 33036845 | Background | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |