Recruiting

ERAS TKR

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT03747146

Conditions

Anesthesia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Continuous Adductor Canal Catheter (ACC)

Adductor Canal block with sham catheter

Study Details

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

Study ID

NCT03747146

Start date

Nov 16, 2018

Status verified date

Jan, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Continuous Adductor Canal Catheter (ACC)

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

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.

Interventions

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.

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.

Primary outcome measure

  • Opioid consumption during 24-48 hour period [ Time Frame: Post-operative day 1-2 (24-48 hours post spinal induction) ]

Central Contacts and Locations

Central contacts

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10023

Principal Investigator:

David Kim, MD

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Apr 28, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-04-28.