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Completed

NCT Number: NCT06691633

Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA

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

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Key information

Conditions

Osteoarthritis (OA) of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

21 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UofL Health

Louisville, Kentucky, 40202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Preoperative Methadone

Drug

patient receives a one-time preoperative dose of 10 mg of methadone

Preoperative Oxycodone

Drug

patient receives a one-time preoperative dose of 10 mg of oral oxycodone

Primary outcomes

  1. Daily Opioid Use

    Time frame: 2 weeks

    Daily Opioid Use as measured in MME recorded daily for the first two weeks following TKA

  2. 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

  3. 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).

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: Up to 2 weeks

    Number of days patient was an inpatient in the hospital prior to discharge date

  2. Discharge location

    Time frame: 2 weeks

    Whether patient was discharged to home or to a rehab facility

  3. Two and six-week narcotic refill

    Time frame: 6 weeks

    Whether patient was prescribed a two week and/or six-week postoperative narcotic refill

  4. Knee Injury and Osteoarthritis Outcome Score, Joint Replacement score

    Time frame: preoperatively and 6 weeks (± 2 weeks) postoperatively

    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.

  5. ROM

    Time frame: preoperatively, 2 weeks and 6 weeks (± 2 weeks) postoperatively

    active range-of-motion (ROM) as measured in degrees of extension and degrees of flexion

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Official study title

Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary Total Knee Arthroplasty, a Prospective, Randomized Study

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2024
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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