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Набор скоро начнётся NCT07573007

Epidural Catheter Placement Techniques by Anesthesia Residents: Success and Complications

— Наблюдательное Epidural Anesthesia Catheterisation Education Postoperative Pain

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: epidural catheter placement.
Кому может быть актуально
Состояния в реестре: Epidural Anesthesia, Catheterisation, Education, Postoperative Pain. Базовые параметры: 18 лет — 80 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
Turkey (Türkiye)
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

Anesthesia Residents' Epidural Catheter Placement Techniques: A Prospective Observational Study on Success Rates and Complications

Обзор

This prospective observational study aims to evaluate the impact of epidural catheter placement techniques - loss of resistance (LOR) and hanging drop (HD) - on first-attempt success rates and procedural complications among anesthesia residents. Residents with at least two years of training will perform epidural catheterization under supervision for patients scheduled for elective surgery requiring perioperative epidural analgesia. An independent observer will record procedural details, complications, and postoperative pain scores. The study will enroll 440 patients aged 18-80 with ASA I-III classification.

Подробное описание

Epidural catheterization is a cornerstone technique in perioperative and obstetric pain management. Two established methods are commonly used to identify the epidural space: the loss of resistance (LOR) technique, using air or normal saline, and the hanging drop (HD) technique. Although both are widely employed, comparative data on their performance by residents in training are limited. This study prospectively observes which technique the resident chooses, records procedural parameters (depth of epidural space, number of attempts, level of insertion), and documents immediate complications (dural puncture, intravascular placement, paresthesia, hypotension) and postoperative outcomes (NRS scores at 0, 6, 12, and 24 hours; PDPH). Cases in which a resident is unable to complete the procedure are documented separately, including the reason for failure and subsequent management by a supervising specialist. All procedures are performed using an 18G Tuohy needle and standard catheter set. A test dose is administered to all patients following catheter placement. Data are recorded by an independent observer using a standardized data collection form.

Вмешательства

  • Процедура epidural catheter placement
    Epidural catheterization performed using an 18G Tuohy needle and standard catheter set by anesthesia residents with a minimum of two years of training, under specialist supervision. Technique selection (LOR or HD) is at the discretion of the performing resident and is not randomized.

Первичные конечные точки

  • First-attempt success rate [Срок оценки: Time Frame: Immediately upon procedure completion]
Вторичные конечные точки (7)
  • Dural puncture rate [Срок оценки: Intraoperative]
  • Catheter Advancement Failure Rate [Срок оценки: intraoperative]
  • Operator-Assessed Difficulty Score [Срок оценки: Immediately after procedure completion]
  • Intravascular catheter placement rate [Срок оценки: intraoperative]
  • Postoperative Pain Scores [Срок оценки: 0, 6, 12, and 24 hours postoperatively]
  • Rate and Type of Assistance Required During Catheter Placement [Срок оценки: Intraoperative]
  • First-Attempt Success Rate Stratified by Resident Seniority Level [Срок оценки: Intraoperative]

Критерии участия

Критерии включения

  • Age 18-80 years
  • ASA physical status I, II, or III
  • Scheduled for elective surgery requiring perioperative epidural analgesia or anesthesia (lumbar or thoracic approach)
  • Epidural catheter to be placed by a resident with ≥ 2 years of anesthesia training

Критерии исключения

  • Spinal deformity (scoliosis, kyphosis, or prior spinal surgery at the target level)
  • Coagulopathy or anticoagulant therapy precluding neuraxial blockade
  • Active infection at the insertion site or systemic infection
  • Pre-existing neurological disease affecting the spinal cord or nerve roots
  • Emergency surgery
  • History of prior failed epidural catheterization
  • Patient refusal or inability to provide written informed consent
  • Local anatomical pathology precluding safe epidural access

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Turkey (Türkiye) · 1 центр
  • Marmara University Pendik Training and Research Hospital — Istanbul

Публикации

  • 1. Hoffmann VL, Vercauteren MP, Vreugde JP, Hans GH, Coppejans HC, Adriaensen HA. Posterior epidural space depth: safety of the loss of resistance and hanging drop techniques. British Journal of Anaesthesia. 1999;83(5):807-811. 2. Günaydın B, Tan A, Doğru O, Mutlu M, Öztürk G, Güler HG. Comparison of spring-loaded, loss of resistance and hanging drop techniques in lumbar epidural blocks. Agri. 201

Идентификаторы

NCT: NCT07573007 · mü anesthesia

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗