RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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.

Quick Facts

Study Start:2023-06-12
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05981105

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with osteoarthritis scheduled for a primary total knee arthroplasty with a participating surgeon
  2. * Age 18 to 75 years
  3. * Planned use of regional anesthesia
  4. * Ability to follow study protocol
  5. * English speaking (secondary outcomes include questionnaires validated in English only)
  6. * Patients of participating surgeons: Drs. Mayman, Jerabek, Westrich, Su, Della Valle, Alexiades
  7. * Lives within one hour of the hospital
  8. * Has a smartphone
  1. * Hepatic or renal insufficiency
  2. * Younger than 18 years old and older than 65
  3. * Patients undergoing general anesthesia
  4. * Allergy or intolerance to one of the study medications
  5. * BMI \> 40
  6. * Diabetes
  7. * ASA of III,IV
  8. * Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
  9. * PCS \> 30
  10. * Chronic opioid use (taking opioids for longer than 3 months, or daily oral morphine equivalent of \>5mg/day for one month)
  11. * Patients with severe valgus deformity or flexion contracture
  12. * Patients unable to follow home catheter instructions and unwilling to go home with an infusing catheter
  13. * Patients who have no home caregivers in the event if a catheter is to be sent home with the patient
  14. * Patients with planned stay at rehab facility

Contacts and Locations

Study Contact

Justas Lauzadis, PhD
CONTACT
212-774-2946
lauzadisj@hss.edu
Stavros Memtsoudis, MD/PhD
CONTACT
212-606-1036
memtsoudiss@hss.edu

Principal Investigator

Stavros Memtsoudis, MD/PhD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Justas Lauzadis, PhD
STUDY_DIRECTOR
Hospital for Special Surgery, New York

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Stavros Memtsoudis, MD/PhD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York
  • Justas Lauzadis, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-06-12
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2023-06-12
Study Completion Date2025-01-01

Terms related to this study

Additional Relevant MeSH Terms

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