Идёт набор NCT07348614

Flex Appeal: Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia

Фаза IV С лечением Knee Stiffness After Total Knee Arthroplasty

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: Spinal Anesthesia, General Anesthesia, Propofol, Chloroprocaine.
Кому может быть актуально: Состояния в реестре: Knee Stiffness After Total Knee Arthroplasty. Базовые параметры: 18 лет — 75 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: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Flex Appeal: A Prospective Randomized Controlled Trial Evaluating the Efficacy of Anesthetic Techniques for Manipulation of Knees Under Anesthesia (MUA)

Обзор

The purpose of this study is to determine if changing the type of anesthesia improves the outcomes of manipulation and pain control after the procedure. The study will compare a spinal anesthesia with a general anesthesia, to see if there is a better outcome from either anesthesia type.

Вмешательства

Процедура Spinal Anesthesia
Administration of spinal anesthesia for knee manipulation.
Процедура General Anesthesia
Administration of general anesthesia for knee manipulation.
Препарат Propofol
Patients undergoing general anesthesia will receive an induction dose of propofol that will be titrated to effect, and airway support as needed until the patient is appropriately anesthetized for the procedure as determined by the anesthesia and surgical care teams.
Препарат Chloroprocaine
Patients undergoing spinal anesthesia will receive a spinal injection under standard aseptic technique, with 45mg chloroprocaine.

Первичные конечные точки

Change in degrees of motion of the affected knee [Срок оценки: At time of procedure completion]

Вторичные конечные точки (2)

Change in pain [Срок оценки: Baseline, 24 hours, 48 hours, 72 hours post-procedure]
Opioid use in PACU [Срок оценки: Day 3]

Критерии участия

Inclusion:

Patients ≥18 years presenting for a manipulation of knee joint under anesthesia.
ASA Classification I - III.
English speaking patients.

Exclusion:

ASA 4 or 5
Daily chronic opioid use (over 3 months of continuous opioid use).
Inability to communicate pain scores or need for analgesia.
Infection at the site of block placement
Age under 18 years old or greater than 75 years old
Pregnant women (as determined by point-of-care serum bHCG)
Intolerance/allergy to local anesthetics
Weight <50 kg
Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
BMI >50 kg/m2.
Allergy or contraindication to local anesthetics or any component of the multimodal analgesic regimen

(NSAIDs and acetaminophen)