New treatment option for Chronic Pain
Official title Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT05981105
What this study is testing
- What it's testing
- The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is: 1\.
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
- Age 18 to 75 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
You likely can't join if
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 65
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI \> 40
- Diabetes
See the full eligibility criteria
- Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
- Age 18 to 75 years
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
- Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle, Alexiades
- Lives within one hour of the hospital
- Has a smartphone
- Hepatic or renal insufficiency
- Younger than 18 years old and older than 65
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI \> 40
- Diabetes
- ASA of III,IV
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- PCS \> 30
- Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)
- Patients with severe valgus deformity or flexion contracture
- Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter
- Patients who have no home caregivers in the event if a catheter is to be sent home with the patient
- Patients with planned stay at rehab facility
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, 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 study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, 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.