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

Part of paid clinical trials in New York, New York.

Sponsor
Hospital for Special Surgery, New York
Study ID
NCT05981105
Status
Recruiting
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Conditions

  • Adductor Canal Block
  • Chronic Pain
  • Opioid Use
  • Total Knee Arthroplasty

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ambIT pump with catheter — DEVICE
    0.2% ropivacaine will be infused through a catheter pump at a rate of 10 ml/hr, 600 ml reservoir.
  • ambIT pump with sham catheter — DEVICE
    sham catheter with no infusion

Study Details

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.

Key Dates

Start date
Jun 12, 2023
Status verified
Jul 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Adductor Canal Catheter (ACC) - Interventional
    Patients will received the an adductor canal catheter that continuously infuses numbing medication to their operative leg for 50 hours post-surgery. Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.
  • Sham Comparator: Adductor Canal Block (ACB) - Control
    Patients will received the a sham adductor canal catheter that is attached to their operative leg for 50 hours post-surgery. Patients will also communicate with their pain doctor via the Diagnotes application while the catheter is in place.

Primary Outcome Measure

Opioid consumption at 24-48 hours [ Time Frame: from 24 hours to 48 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital for Special SurgeryNew YorkNew York10021
Justas Lauzadis, PhD
[email protected]
212-774-2946
Pa Thor, PhD
646-797-8535

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