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Набор скоро начнётся NCT07661628

Clinical Characteristics of Prilocaine for Spinal Anesthesia in Ambulatory Surgery: Clinical Profile and Efficacy

Наблюдательное Healthy

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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Healthy. 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
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Introduction: Hyperbaric prilocaine is widely used internationally for outpatient orthopedic and perineal surgery because of its favorable recovery profile compared with other intermediate-acting local anesthetics, such as bupivacaine, and its lower incidence of transient neurologic symptoms compared with lidocaine. Recently approved for intrathecal use in Chile, prilocaine offers advantages including shorter onset time, faster motor recovery, and earlier return of bladder function. Objective: To describe the clinical use of intrathecal prilocaine in outpatient knee arthroscopy, including the characteristics of sensory and motor block, incidence of anesthesia-related complications, and hospital readmissions. The study hypothesizes that prilocaine enables rapid postoperative recovery, early ambulation, and a low incidence of complications such as urinary retention, nausea and vomiting, and hypotension. Methods: Following institutional ethics committee approval and written informed consent, a prospective descriptive study will be conducted in 50 ASA physical status I-II patients undergoing ambulatory knee arthroscopy. Spinal anesthesia will be performed using 40 mg of 2% prilocaine under standard monitoring, with supplemental oxygen and midazolam sedation. Surgical type and duration will be recorded. Outcomes will include sensory and motor block duration, time to ambulation, time to first voiding, time to discharge, and the occurrence of complications such as urinary retention, nausea and vomiting, and hypotension during recovery. As this is a convenience sample, no formal sample size calculation has been performed. Data will be analyzed descriptively and reported as means and standard deviations, without inferential statistical testing.

Подробное описание

Introduction

The increasing number of surgical conditions managed in the outpatient setting has become a reality in contemporary clinical practice. Knee arthroscopy for meniscal pathology is a common orthopedic procedure of short duration that requires early postoperative discharge. In this ambulatory setting, spinal anesthesia plays an important role by providing adequate surgical anesthesia while maintaining a limited duration of action, thereby reducing recovery room stay and facilitating safe and efficient patient discharge.

Prilocaine is a local anesthetic widely used worldwide in ambulatory surgery, particularly for orthopedic and perineal procedures. It offers several advantages over other intermediate-acting local anesthetics, such as bupivacaine, and is associated with a lower incidence of transient neurologic symptoms compared with lidocaine.

Until recently, hyperbaric prilocaine had not been available in our country for intrathecal administration. Its use has now been approved by the Chilean Public Health Institute (ISP) (approval attached). Hyperbaric prilocaine has a favorable profile for ambulatory patients, including a shorter onset time, faster motor recovery, and a shorter time to first voiding.

Objective

The aim of this project is to describe the local use of intrathecal prilocaine, including the clinical characteristics of sensory and motor block, the incidence of anesthesia-related complications, and potential readmissions following outpatient knee arthroscopy.

Hypothesis: The use of prilocaine in short-duration outpatient knee arthroscopy facilitates early discharge from the recovery unit, allows rapid postoperative ambulation following spinal anesthesia, and is associated with a low incidence of complications such as urinary retention, postoperative nausea and vomiting, and hypotension, as reported in studies from other countries.

Research Question: What is the clinical performance of prilocaine in short-duration outpatient knee arthroscopy and what are the associated patient outcomes?

Materials and Methods

Following approval by the Institutional Ethics Committee of the Faculty of Medicine, Pontificia Universidad Católica de Chile (Santiago, Chile), and after obtaining written informed consent, a prospective study will be conducted in 50 ASA physical status I-II patients scheduled for outpatient knee arthroscopy. This sample represents a convenience cohort selected for descriptive purposes.

In the operating room, a peripheral intravenous catheter (18-20 G) will be inserted for the administration of fluids and medications. Spinal anesthesia will be performed using 40 mg of 2% prilocaine under standard monitoring, including continuous electrocardiography, noninvasive blood pressure monitoring, and pulse oximetry. Supplemental oxygen will be administered via Campbell mask, and sedation will be provided with 1-2 mg of midazolam.

The type and duration of surgery will be recorded. Anesthetic outcomes will include the duration of sensory and motor block, time to ambulation, time to first voiding, and time to discharge. In addition, complications occurring during the recovery period, including urinary retention, postoperative nausea and vomiting, and hypotension, will be documented.

No formal sample size calculation was performed, as the study will include a convenience sample of 50 patients.

A descriptive analysis will be conducted, with continuous variables reported as means and standard deviations. No inferential statistical tests will be performed.

Первичные конечные точки

  • Sensory block [Срок оценки: From spinal anesthesia to discharge (4 hours)]
  • motor block [Срок оценки: From spinal to discharge (4 hours)]
Вторичные конечные точки (2)
  • Time to walk [Срок оценки: From spinal anesthesia to discharge (4 hours)]
  • Time to discharge [Срок оценки: From spinal anesthesia to discharge (4 hours)]

Критерии участия

Критерии включения

  • outpatient knee arthroscopic surgery

Критерии исключения

  • pediatric patients
  • hospitalized patients

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Ambrosoli AL, Di Carlo S, Crespi A, Severgnini P, Fedele LL, Cofini V, Necozione S, Musella G. Safety and effectiveness of prilocaine for spinal anesthesia in day surgery setting: a retrospective study on a sample of 3291 patients. J Anesth Analg Crit Care. 2023 Oct 20;3(1):40. doi: 10.1186/s44158-023-00122-6. PMID 37864260

Идентификаторы

NCT: NCT07661628 · 250926001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗