- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03747146
Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service (EKAT-TeleTPS)
April 23, 2026 updated by: Hospital for Special Surgery, New York
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-blind Controlled Trial
A comparison of two anesthetic techniques for total knee replacements: (1) Peri-Articular Injection (PAI), local infiltration between the popliteal artery and capsule of the knee block (IPACK) and single-shot adductor canal block (ACB) vs. (2) PAI, IPACK and continuous adductor canal block catheter (ACC).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Patients will be randomized to one of two groups: one group will receive a PAI, IPACK and single-shot adductor canal block; one group will receive PAI, IPACK and continuous adductor canal block catheter.
Study Type
Interventional
Enrollment (Estimated)
94
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: George Birch, BS
- Phone Number: 212-774-7377
- Email: birchg@hss.edu
Study Locations
-
-
New York
-
New York, New York, United States, 10023
- Recruiting
- Hospital for Special Surgery
-
Principal Investigator:
- David Kim, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 61 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
- Planned use of regional anesthesia
- Ability to follow study protocol
- English speaking (secondary outcomes include questionnaires validated in English only)
- Lives within one hour of the hospital
- Has a smart phone
Exclusion Criteria:
- Hepatic or renal insufficiency
- Younger than 18 years old or older than 65 years ol
- Patients undergoing general anesthesia
- Allergy or intolerance to one of the study medications
- BMI >40
- Diabetes
- American Society of Anesthesiologists (ASA) status III or IV
- Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
- Patients with chronic pain (from a referral to chronic pain service) or a pain catastrophizing scale (PCS >30)
- 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 that a catheter is to be sent home with the patient
- Patients with planned stay at rehab facility (to avoid medical device being tampered with at the rehab facility)
- Non-English speakers (secondary outcomes include questionnaires validated in English only)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Continuous Adductor Canal Catheter (ACC)
Patients will receive a combined spinal epidural, PAI, IPACK, and a continuous adductor canal catheter
|
At the end of the case or in the PACU, a pseudo sham catheter will be affixed mid-thigh to the skin using dermabond, steri-strips, and a chg tegaderm dressing.
The catheter will be connected to the disposable pump filled with sterile saline (400 cc) and the flow rate will be set to 0. The pump will be enclosed in a carrier bag provided by the company.
To ensure blinding, the carrier bag will be taped to prevent the patient from accessing it.
|
|
Sham Comparator: Adductor Canal block with sham catheter
Patients will receive a combined spinal epidural, PAI, IPACK, and an adductor canal block.
The patient will also receive a sham catheter.
|
Adductor canal block (ACB) will be administered.
At the end of the case or in the PACU, a catheter will be inserted and affixed mid-thigh to the skin using dermabond, steri-strips, and a chg tegaderm dressing.
The catheter will be connected to the disposable pump filled with sterile saline (400 cc) and the flow rate will be set to 0. The pump will be enclosed in a carrier bag provided by the company.
To ensure blinding, the carrier bag will be taped to prevent the patient from accessing it.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption during 24-48 hour period
Time Frame: Post-operative day 1-2 (24-48 hours post spinal induction)
|
Patients will be asked to report their opioid consumption during the 24-48 hour time period after spinal induction.
This data will be converted to morphine milligram equivalents (mme).
|
Post-operative day 1-2 (24-48 hours post spinal induction)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption during post-anesthesia care unit (PACU) stay
Time Frame: Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours)
|
Patients will be asked to report their opioid consumption during their stay in the post-anesthesia care unit.
This data will be converted to morphine milligram equivalents (mme).
|
Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Kim, MD, Hospital for Special Surgery, New York
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 16, 2018
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
November 6, 2018
First Submitted That Met QC Criteria
November 16, 2018
First Posted (Actual)
November 20, 2018
Study Record Updates
Last Update Posted (Actual)
April 28, 2026
Last Update Submitted That Met QC Criteria
April 23, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- 2017-1858
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.