Epidural Catheter Placement Techniques by Anesthesia Residents: Success and Complications (EPİ-TECH)
1 de mayo de 2026 actualizado por: dilara gocmen, Marmara University Pendik Training and Research Hospital
Anesthesia Residents' Epidural Catheter Placement Techniques: A Prospective Observational Study on Success Rates and Complications
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.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Estimado)
Inscripción
440
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: dilara göçmen, Asst prof
- Número de teléfono: +90 216 625 4545
- Correo electrónico: dilara.gocmen@marmara.edu.tr
Ubicaciones de estudio
-
-
Maltepe
-
Istanbul, Maltepe, Turquía (Türkiye), 34852
- Marmara University Pendik Training and Research Hospital
-
Contacto:
- dilara göçmen, Asst prof
- Número de teléfono: +90 216 625 4545
- Correo electrónico: dilara.gocmen@marmara.edu.tr
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
Adult patients scheduled for elective/emergency surgery with planned perioperative epidural analgesia or anesthesia at Marmara University Pendik Training and Research Hospital, Department of Anesthesiology and Reanimation.
Descripción
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Número de grupos/cohortes
2
Cohortes e Intervenciones
Grupo / CohorteGrupo / Cohorte |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Loss of Resistance (LOR) Group
Patients in whom the epidural space is identified using the loss of resistance technique.
The attending resident uses a syringe filled with air or normal saline attached to the Tuohy needle hub and advances until resistance disappears upon entering the epidural space.
|
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.
Otros nombres:
|
|
Hanging Drop (HD) Group
Patients in whom the epidural space is identified using the hanging drop technique.
A drop of normal saline is placed at the Tuohy needle hub and observed to be aspirated inward by the negative epidural pressure as the needle tip traverses the ligamentum flavum.
|
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
First-attempt success rate
Periodo de tiempo: Time Frame: Immediately upon procedure completion
|
Defined as successful epidural space identification and catheter placement in a single Tuohy needle insertion attempt, without redirecting the needle.
|
Time Frame: Immediately upon procedure completion
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dural puncture rate
Periodo de tiempo: Intraoperative
|
Inadvertent dural puncture defined as free flow of cerebrospinal fluid through the Tuohy needle or epidural catheter, confirmed by visual inspection.
Recorded as yes/no by the independent observer at the time of the procedure
|
Intraoperative
|
|
Catheter Advancement Failure Rate
Periodo de tiempo: intraoperative
|
Inability to thread the epidural catheter beyond 3 cm into the epidural space despite confirmed needle placement, necessitating needle repositioning or procedure abandonment.
Recorded as yes/no by the independent observer.
|
intraoperative
|
|
Operator-Assessed Difficulty Score
Periodo de tiempo: Immediately after procedure completion
|
The performing resident rates the overall technical difficulty of the procedure immediately upon completion using a 5-point Likert scale: 1 = very easy, 2 = easy, 3 = moderate, 4 = difficult, 5 = very difficult.
Recorded on the standardized data collection form
|
Immediately after procedure completion
|
|
Intravascular catheter placement rate
Periodo de tiempo: intraoperative
|
Unintentional intravascular placement defined as aspiration of blood through the epidural catheter prior to test dose administration.
Recorded as yes/no by the independent observer immediately following catheter advancement
|
intraoperative
|
|
Postoperative Pain Scores
Periodo de tiempo: 0, 6, 12, and 24 hours postoperatively
|
Pain intensity assessed using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst imaginable pain.
Recorded at four time points: immediately upon arrival to the recovery unit (0 hours), and at 6, 12, and 24 hours postoperatively by the independent observer.
|
0, 6, 12, and 24 hours postoperatively
|
|
Rate and Type of Assistance Required During Catheter Placement
Periodo de tiempo: Intraoperative
|
The level of assistance received by the performing resident is recorded in three categories: (1) No assistance - procedure completed independently; (2) Verbal guidance only - supervising specialist provides verbal instructions without physical intervention; (3) Physical assistance - supervising specialist takes over needle or catheter manipulation partially or completely.
Recorded by the independent observer at the time of the procedure.
|
Intraoperative
|
|
First-Attempt Success Rate Stratified by Resident Seniority Level
Periodo de tiempo: Intraoperative
|
First-attempt success rates are compared across three seniority strata defined by duration of anesthesia training: junior residents (2-3 years), intermediate residents (3-4 years), and senior residents (4 years and above).
Seniority is determined by the total duration of anesthesia specialty training at the time of the procedure.
|
Intraoperative
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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. 2012;24(1):13-18. 3. Azizov S, Okcu M, Goksu H. Could the Hanging Drop Technique Be an Alternative Method to Loss of Resistance in Cervical Epidural Injections? Pain Physician. 2025;28:217-221. 4. Tran DQH, González AP, Bernucci F, Finlayson RJ. Confirmation of Loss-of-Resistance for Epidural Analgesia. Regional Anesthesia and Pain Medicine. 2015;40(2):166-173. 5. Yoshida K, Tanaka S, Watanabe K. Hanging-Drop Technique Is More Suitable for Epidural Space Confirmation in Patients With Subcutaneous Emphysema After Traumatic Multiple Rib Fractures. Journal of Cardiothoracic and Vascular Anesthesia. 2023;37(12). 6. Konrad C, Schüpfer G, Wietlisbach M, Gerber H. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesthesia & Analgesia. 1998;86(3):635-639. 7. De Oliveira GS, Glassenberg R, Chang R, Fitzgerald P, McCarthy R. Virtual airway simulation to improve dexterity among novices performing fibreoptic intubation. Anaesthesia. 2013;68(10):1053-1058. 8. Kopacz DJ, Neal JM, Pollock JE. The regional anesthesia learning curve. Regional Anesthesia. 1996;21(3):182-190. 9. Naik VN, Devito I, Halpern SH. Cusum analysis is a useful tool to assess resident proficiency at epidural anesthesia. Canadian Journal of Anesthesia. 2004;51(7):703-708.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
1 de mayo de 2026
Finalización primaria (Estimado)
Finalización primaria
1 de mayo de 2027
Finalización del estudio (Estimado)
Finalización del estudio
1 de junio de 2027
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
1 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
1 de mayo de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
7 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
7 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
1 de mayo de 2026
Última verificación
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- mü anesthesia
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .