Enhanced Recovery After Surgery (ERAS) Total Knee Replacement (TKR) With a Transitional Pain Service

NCT03747146 | Recruiting FDA Device

• 1 other identifier: 2017-1858
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption during 24-48 hour period

  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 Outcomes (1)

• Opioid consumption during post-anesthesia care unit (PACU) stay

  Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours)

Study Arms (2)

Continuous Adductor Canal Catheter (ACC)

ACTIVE COMPARATOR

Patients will receive a combined spinal epidural, PAI, IPACK, and a continuous adductor canal catheter

Device: Continuous Adductor Canal Catheter (ACC)

Adductor Canal block with sham catheter

SHAM COMPARATOR

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

Interventions

Continuous Adductor Canal Catheter (ACC) DEVICE

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.

Continuous Adductor Canal Catheter (ACC)

Adductor Canal block with sham catheter DEVICE

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.

Adductor Canal block with sham catheter

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10023, United States

RECRUITING

Study Officials

• David Kim, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Birch, BS

CONTACT

212-774-7377; birchg@hss.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 20, 2018
• Study Start: November 16, 2018
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-01

Locations

US (1)