Clinical trial NCT06691633: Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA
Official title: Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis (OA) of the Knee
Keywords: osteoarthritis
knee
total knee arthroplasty
prospective RCT
preoperative analgesia
Methadone
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized cohort analysis study
Primary purpose: BASIC_SCIENCE

Brief 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 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


Eligibility criteria: Inclusion Criteria:

1. Patient age is 21-89 at time of surgery
2. Patient is scheduled to undergo a unilateral primary TKA, secondary to osteoarthritis
3. Patient agrees to participate as a study subject and signs the Informed Consent and Research Authorization document
4. Patient is able to read and speak English.

Exclusion Criteria:

1. Patient is under the age of 21
2. Patient's primary diagnosis is not osteoarthritis
3. Patient is unable to read and speak English
4. History of liver or kidney disease,
5. Known or suspected GI obstruction
6. Hypersensitivity to methadone
7. Patients with significant respiratory depression
8. Pregnant or nursing females

Primary outcomes:
measure: Daily Opioid Use
timeFrame: 2 weeks
measure: Total opioid usage over two weeks
timeFrame: 2 weeks
measure: Visual Analogue Scale pain score
timeFrame: 2 weeks
Secondary outcomes:
measure: Hospital Length of Stay
timeFrame: Up to 2 weeks
measure: Discharge location
timeFrame: 2 weeks
measure: Two and six-week narcotic refill
timeFrame: 6 weeks
measure: Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score
timeFrame: preoperatively and 6 weeks (± 2 weeks) postoperatively
measure: ROM
timeFrame: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively
Other outcomes:
Locations:
city: Louisville
country: United States
facility: UofL Health
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Rodolfo Zamora, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.