NCT05981105 Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty
| NCT ID | NCT05981105 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital for Special Surgery, New York |
| Condition | Chronic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2023-06-12 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2023-06-12 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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\. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)? Participants will be: * Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter. * Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place. * Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation.
Eligibility 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
Contact & Investigator
Stavros Memtsoudis, MD/PhD
PRINCIPAL INVESTIGATOR
Hospital for Special Surgery, New York
Frequently Asked Questions
Who can join the NCT05981105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05981105 currently recruiting?
Yes, NCT05981105 is actively recruiting participants. Contact the research team at thorp@hss.edu for enrollment information.
Where is the NCT05981105 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05981105 clinical trial?
NCT05981105 is sponsored by Hospital for Special Surgery, New York. The principal investigator is Stavros Memtsoudis, MD/PhD at Hospital for Special Surgery, New York. The trial plans to enroll 64 participants.
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