Recruiting

Methadone

Sponsor:

AdventHealth

Code:

NCT07485803

Conditions

Total Knee Arthroplasty

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Methadone

Study Details

Brief summary:

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.

Conditions

Total Knee Arthroplasty

Study ID

NCT07485803

Start date

Jun 1, 2026

Status verified date

Mar, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Provision of signed and dated informed consent from
2. Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
3. Age 21- 75
4. Unilateral total knee arthroplasty at Colorado Joint Replacement
5. All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment
6. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation.

Exclusion Criteria:

1. Narcotic use in the past 6 weeks
2. Current or previous history of drug and alcohol abuse
3. Tobacco use in the previous 90 days
4. Treatment with another investigational drug
5. Patients that cannot receive spinal anesthesia
6. Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'
7. Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility
8. Obstructive sleep apnea
9. Morbid obesity (BMI >40)
10. Patients with liver disease.
11. Significant kidney disease - stage 3 CKD or greater
12. Pregnant or nursing females
13. Baseline QTc >480
14. severe COPD (GOLD 3 or 4)
15. home oxygen requirement

Study Design

Enrollment

192 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Methadone

Patient will receive one perioperative dose of IV methadone prior to their surgical procedure in addition to standard of care medications.

no intervention: No medication

Patient will receive only the standard of care medications for their procedure.

Interventions

Methadone

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

Primary outcome measure

  • Opioid use for 48 hours post-operatively [ Time Frame: 48 hours after TKA procedure ]

Central Contacts and Locations

Central contacts

Locations

AdventHealth Porter

Recruiting

Denver, Colorado, United States, 80210

Contacts

More Information

Sponsor

AdventHealth

Last update posted

Jun 22, 2026

Last verified

Mar, 2026

Keywords

  • pain management
  • TKA
  • methadone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AdventHealth on 2026-06-22.