RecruitingNot ApplicableNCT03747146

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

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

Sponsor

Hospital for Special Surgery, New York

Enrollment

94 participants

Start Date

Nov 16, 2018

Study Type

INTERVENTIONAL

Conditions

Anesthesia

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).

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria14

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)

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Interventions

DEVICEContinuous 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.

DEVICEAdductor 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.