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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Opioid consumption during post-anesthesia care unit (PACU) stay [Срок оценки: Day of surgery from PACU arrival until transfer to in-patient floor (up to 48 hours)]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Hospital for Special Surgery — New York

Публикации

• Kim DH, Beathe J, Wetmore DS, Goytizolo E, Haskins SC, Swamidoss C, Reichel JF, Reisenger L, Rao P, Memtsoudis SG, Liu J. Single-injection adductor canal block with perineural dexamethasone versus continuous adductor canal catheter for total knee arthroplasty: a randomized controlled trial. Reg Anesth Pain Med. 2026 Jun 4:rapm-2026-107719. doi: 10.1136/rapm-2026-107719. Online ahead of print. PMID 42242837

Идентификаторы

NCT: NCT03747146 · 2017-1858

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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