RecruitingNot ApplicableNCT05981105

Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty

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.


Sponsor

Hospital for Special Surgery, New York

Enrollment

64 participants

Start Date

Jun 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria8

  • 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 Criteria14

  • 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

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Interventions

DEVICEambIT pump with catheter

0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.

DEVICEambIT pump with sham catheter

sham catheter with no infusion


Locations(1)

Hospital for Special Surgery

New York, New York, United States

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NCT05981105


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