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Идёт набор NCT06784882

Continuous Versus Single Injection Adductor Canal Blocks for Outpatient Total Knee Arthroplasty

Фаза IV С лечением Acute Postoperative Pain Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: continuous peripheral nerve block with OnQ pump, single injection nerve block.
Кому может быть актуально
Состояния в реестре: Acute Postoperative Pain, Surgery. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

A Pilot Randomized Controlled Trial Assessing Pain and Opioid Outcomes Among Patients Undergoing Total Knee Arthroplasty Receiving 5-Day Outpatient Adductor Canal Continuous Versus Single Injection Blocks

Обзор

This is a single-center pilot study to determine if an adductor canal continuous nerve block is superior to single injection nerve block following total knee arthroplasty. Investigators will randomize participants to either continuous nerve block or single injection nerve block for the adductor canal preoperatively. They will assess differences in pain (measured in numeric rating scale), opioid consumption, and physical therapy milestones from postoperative day 0 to 7.

Подробное описание

Adductor canal blocks are standard care for postoperative analgesia following total knee arthroplasty. Adductor canal blocks involve depositing local anesthetic (ropivacaine) around the saphenous nerve at the location of the adductor canal on the ipsilateral thigh. At UCSD, the standard care is to perform single injection adductor canal blocks for research participants undergoing total knee arthroplasty prior to surgery in the preoperative waiting area.

Participants will be randomized to either: (1) single injection with ropivacaine (0.5%) of the adductor canal block AND a 5-day continuous perineural infusion of ropivacaine (0.2%) (experimental group); versus (2) single injection with ropivacaine (0.5%) of the adductor canal block and no continuous nerve block added.

Вмешательства

  • Устройство continuous peripheral nerve block with OnQ pump
    For continuous nerve blocks, the infusion pump that will be used are OnQ pumps (Avanos, Alpharetta, GA) and pre-filled with ropivacaine 0.2% and provided by UCSD's Investigational Drug Services.
  • Препарат single injection nerve block
    An adductor canal single injection nerve block will be performed per standard of care. The adductor canal will be identified by ultrasound in the short-axis view. The distal aspect of the femoral triangle (and beginning of the adductor canal) will be identified distal to the mid-thigh in the ipsilateral limb. Using ultrasound guidance, a standard Tuohy block needle will be advanced through a skin wheal of lidocaine until its tip is in the hypoechoic area immediately distal saphenous nerve adjace

Первичные конечные точки

  • analgesic effect of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine. [Срок оценки: 7 days]
  • opioid consumption of 5-day continuous nerve block of the adductor canal relative to a single inection nerve block with ropivacaine. [Срок оценки: 7 days]
Вторичные конечные точки (4)
  • physical and emotional functioning of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine [Срок оценки: 7 days]
  • improvement in physical therapy milestones of 5-day continuous nerve blocks relative to a single injection nerve blocks with ropivacaine [Срок оценки: 30 days]
  • 30-day pain score measured in Numeric Rating Scale [Срок оценки: 30 days]
  • 30-day postoperative opioid consumption [Срок оценки: 30 days]

Критерии участия

Критерии включения

  • Adult participants of at least 18 years of age
  • Undergoing a primary, unilateral, total knee arthroplasty
  • Planned single-injection adductor canal nerve block
  • Weight > 50 kg (to minimize the risk of local anesthetic toxicity)

Критерии исключения

  • chronic opioid or tramadol use: daily oxycodone equivalents > 20 mg for > 4 weeks
  • neuro-muscular deficit of the surgical limb
  • moderate pain (NRS > 3) in an anatomic location other than the surgical site
  • planned hospital admission following surgery
  • history of opioid misuse
  • those who lack capacity to complete informed consent
  • inability to contact the investigators during the treatment period, and vice versa (e.g., lack of telephone access)
  • incarceration
  • pregnancy
  • allergy to amide local anesthetics

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • University of California, San Diego — La Jolla

Публикации

  • Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the America PMID 26827847

Идентификаторы

NCT: NCT06784882 · 811228

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗