Postoperative Pain and Analgesic Requirements After Preoperative Methadone for Primary TKA

University of Louisville (UOFL)

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis (OA) of the Knee

Treatments: Drug: Preoperative Oxycodone; Drug: Preoperative Methadone

Study type: Interventional

Funder types: Other

Identifiers

NCT06691633

23.0752

Details and patient eligibility

About

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

Enrollment: 150 patients

Sex: All

Ages: 21 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 2 patient groups

Methadone Group

Experimental group

Description:

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

Treatment:

Drug: Preoperative Methadone

Oxycodone Group

Active Comparator group

Description:

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

Treatment:

Drug: Preoperative Oxycodone