- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07573007
Epidural Catheter Placement Techniques by Anesthesia Residents: Success and Complications (EPİ-TECH)
May 1, 2026 updated by: 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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Estimated)
440
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: dilara göçmen, Asst prof
- Phone Number: +90 216 625 4545
- Email: dilara.gocmen@marmara.edu.tr
Study Locations
-
-
Maltepe
-
Istanbul, Maltepe, Turkey (Türkiye), 34852
- Marmara University Pendik Training and Research Hospital
-
Contact:
- dilara göçmen, Asst prof
- Phone Number: +90 216 625 4545
- Email: dilara.gocmen@marmara.edu.tr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
Other Names:
|
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
First-attempt success rate
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dural puncture rate
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Intraoperative
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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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Study Registration Dates
First Submitted
May 1, 2026
First Submitted That Met QC Criteria
May 1, 2026
First Posted (Actual)
May 7, 2026
Study Record Updates
Last Update Posted (Actual)
May 7, 2026
Last Update Submitted That Met QC Criteria
May 1, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- mü anesthesia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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