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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: George Birch, BS
  • Phone Number: 212-774-7377
  • Email: birchg@hss.edu

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Continuous Adductor Canal Catheter (ACC)
Patients will receive a combined spinal epidural, PAI, IPACK, and a continuous adductor canal catheter
Device: Continuous Adductor Canal Catheter (ACC)
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.
Device: Adductor Canal block with 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital for Special Surgery, New York

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 16, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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