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Epidural AnesthesiaEPİ-TECHNCT07573007

Epidural Catheter Placement Techniques by Anesthesia Residents: Success and Complications

An observational study of Epidural Anesthesia and Catheterisation, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Epidural Anesthesia, Catheterisation, Education
What is being tested?
epidural catheter placement
How many people
440 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2026to 1 Jun 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dilara Göçmen, asst prof contact

+90 216 625 4545

dilara.gocmen@marmara.edu.tr

Turkey (Türkiye)1 site

  • Marmara University Pendik Training and Research Hospital

    Istanbul, Maltepe, 34852

    dilara göçmen, Asst prof, +90 216 625 4545, dilara.gocmen@marmara.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
epidural catheter placement
Keywords
epidural catheter, loss of resistance, hanging drop, procedural training, epidural space identification
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • epidural catheter placementProcedure or surgery

    Also called neuroaxial blockade

    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.

Study groups in NCT07573007
Study groupRoleWhat they receive
Loss of Resistance (LOR) GroupPatients 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.
Receives: Procedure: epidural catheter placement
Hanging Drop (HD) GroupPatients 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.
Receives: Procedure: epidural catheter placement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First-attempt success rate

    Defined as successful epidural space identification and catheter placement in a single Tuohy needle insertion attempt, without redirecting the needle.

    Measured: Time Frame: Immediately upon procedure completion

Secondary outcomes (7)

  1. Dural puncture rate

    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

    Measured: Intraoperative

  2. Catheter Advancement Failure Rate

    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.

    Measured: intraoperative

  3. Operator-Assessed Difficulty Score

    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

    Measured: Immediately after procedure completion

  4. Intravascular catheter placement rate

    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

    Measured: intraoperative

  5. Postoperative Pain Scores

    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.

    Measured: 0, 6, 12, and 24 hours postoperatively

  6. Rate and Type of Assistance Required During Catheter Placement

    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.

    Measured: Intraoperative

  7. First-Attempt Success Rate Stratified by Resident Seniority Level

    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.

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573007
Sponsor's protocol ID
mü anesthesia
Acronym
EPİ-TECH
Status last verified
May 2026
First submitted
1 May 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Questions about this trial

What is this clinical trial studying?

An observational study of Epidural Anesthesia and Catheterisation, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dilara Göçmen, asst prof (+90 216 625 4545, dilara.gocmen@marmara.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

First-attempt success rate (time frame: Time Frame: Immediately upon procedure completion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07573007, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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