Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHospital for Special Surgery, New York
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ambIT pump with catheter
Device0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.
ambIT pump with sham catheter
Devicesham catheter with no infusion
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Adductor Canal Catheter (ACC) - InterventionalExperimental treatment 1 intervention
Group B: Adductor Canal Block (ACB) - ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Opioid consumption at 24-48 hours
The cumulative opioid consumption 24-48 hours post block administration. Measured in morphine milligram equivalents per day. Although collected over a period of time, the total amount will be summed and the average will be reported.
Time frame
from 24 hours to 48 hoursSecondary outcomes
1
Opioid consumption at 72 hours, 96 hours, and 1 week
The cumulative opioid consumption 72hours, 96 hours, and 1 week post block administration. Measured in morphine milligram equivalents per day. Although collected over a period of time, the total amount will be summed and the average will be reported.
Time frame
72 hours to 1 week2
Numerical Pain Rating Score
Patients are asked to give a number between 0 and 10 that best fits their pain intensity. The scale is 0 = 'no pain at all' whereas 10 = 'the worst pain ever possible'. Measured at multiple time points: DOS, post-operative day (POD) 1, POD 2, POD 3, POD 4, POD 7, \& POD 60
Time frame
Day of surgery to post operative day (POD) 603
Physical Therapy Milestones
Collected from the physical therapy notes. This outcome will assess for time to ambulation (measured in distance traveled, stairs, time of ambulating \> 30 meters, and reaching discharge criteria).
Time frame
post operative day (POD) 1 up to POD 44
Patient Satisfaction with Pain Control
Patients are asked to report on their satisfaction with pain control on a scale of 0 to 10, with 0 = extremely dissatisfied and 10 = extremely satisfied.
Time frame
post operative day (POD) 1, 2, 4 & 60Sponsors and contacts
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Source ClinicalTrials.gov