Improving pain management after total knee surgery
Expanding the Peri-operative Surgical Home Model: ERAS TKR With a Transitional Pain Service (TeleTPS) - Continuous Adductor Canal Catheter Versus Adductor Canal Block for Total Knee Arthroplasty, a Randomized Double-blinded Controlled Trial.
This study is testing whether a special pain management device can help people who have had knee surgery use less opioid medication and feel less pain as they recover.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital for Special Surgery, New York Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05981105 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of an adductor canal catheter (ACC) compared to a sham catheter in reducing opioid consumption and managing pain in patients undergoing total knee arthroplasty. Participants will be randomly assigned to receive either the ACC or a sham catheter and will use a mobile application to communicate with their pain management team. The study will track opioid use and pain levels for up to six months post-surgery, focusing on the potential benefits of extended analgesia and early rehabilitation. The goal is to determine if continuous analgesia can reduce rebound pain and improve recovery outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with osteoarthritis scheduled for total knee arthroplasty who can follow the study protocol and live within one hour of the hospital.
Not a fit: Patients with chronic opioid use, severe comorbidities, or those undergoing general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid use and improve pain management for patients after knee surgery.
How similar studies have performed: Other studies have shown promise in using regional anesthesia techniques to improve pain management and reduce opioid consumption, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * 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
Where this trial is running
New York, New York
- Hospital for Special Surgery — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Stavros Memtsoudis, MD/PhD — Hospital for Special Surgery, New York
- Study coordinator: Pa Thor, PhD
- Email: thorp@hss.edu
- Phone: 646-797-8535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.