Epidural Catheter Placement Techniques by Anesthesia Residents: Success and Complications (EPİ-TECH)
1 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Estimé)
440
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: dilara göçmen, Asst prof
- Numéro de téléphone: +90 216 625 4545
- E-mail: dilara.gocmen@marmara.edu.tr
Lieux d'étude
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Maltepe
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Istanbul, Maltepe, Turquie (Türkiye), 34852
- Marmara University Pendik Training and Research Hospital
-
Contact:
- dilara göçmen, Asst prof
- Numéro de téléphone: +90 216 625 4545
- E-mail: dilara.gocmen@marmara.edu.tr
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Méthode d'échantillonnage
Échantillon de probabilité
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
Autres noms:
|
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
First-attempt success rate
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dural puncture rate
Délai: 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
Délai: 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
Délai: 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
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Immediately after procedure completion
|
|
Intravascular catheter placement rate
Délai: intraoperative
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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
|
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Postoperative Pain Scores
Délai: 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.
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0, 6, 12, and 24 hours postoperatively
|
|
Rate and Type of Assistance Required During Catheter Placement
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 mai 2026
Achèvement primaire (Estimé)
1 mai 2027
Achèvement de l'étude (Estimé)
1 juin 2027
Dates d'inscription aux études
Première soumission
1 mai 2026
Première soumission répondant aux critères de contrôle qualité
1 mai 2026
Première publication (Réel)
7 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
7 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- mü anesthesia
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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