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New treatment option for Total Knee Arthroplasty
Official title Methadone in the Management of Post-Operative Pain in Total Knee Replacement
ClinicalTrials.gov ID: NCT07485803
What this study is testing
What is Methadone?
Methadone is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for total knee arthroplasty.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- Provision of signed and dated informed consent from
- Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
- Age 21- 75
- Unilateral total knee arthroplasty at Colorado Joint Replacement
- All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment
You likely can't join if
- Narcotic use in the past 6 weeks
- Current or previous history of drug and alcohol abuse
- Tobacco use in the previous 90 days
- Treatment with another investigational drug
- Patients that cannot receive spinal anesthesia
- Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'
See the full eligibility criteria
- Provision of signed and dated informed consent from
- Stated willingness to comply with all study procedures and availability to attend all required visits for the duration of the study.
- Age 21- 75
- Unilateral total knee arthroplasty at Colorado Joint Replacement
- All individuals will be screened for drug use (opioid use, illicit drug use) at their preoperative appointment
- 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.
- Narcotic use in the past 6 weeks
- Current or previous history of drug and alcohol abuse
- Tobacco use in the previous 90 days
- Treatment with another investigational drug
- Patients that cannot receive spinal anesthesia
- Patients that cannot receive the standardized multimodal pain medications (i.e. Tylenol, gabapentin and meloxicam)'
- Patients that are not able to go home after leaving the hospital and require a short-term rehabilitation facility
- Obstructive sleep apnea
- Morbid obesity (BMI \>40)
- Patients with liver disease.
- Significant kidney disease - stage 3 CKD or greater
- Pregnant or nursing females
- Baseline QTc \>480
- severe COPD (GOLD 3 or 4)
- home oxygen requirement
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.