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NCT Number: NCT07573007

Epidural Catheter Placement Techniques by Anesthesia Residents: Success 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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Marmara University Pendik Training and Research Hospital

Istanbul, Maltepe, 34852, Turkey (Türkiye)

Location contact

dilara göçmen, Asst prof

CONTACT

[email protected]

+90 216 625 4545

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural catheter placement

Procedure

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: neuroaxial blockade

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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.

  6. Rate and Type of Assistance Required During Catheter Placement

    Time frame: 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilara Göçmen, asst prof

CONTACT

[email protected]

+90 216 625 4545

Sponsors and collaborators

Lead sponsor

Marmara University Pendik Training and Research Hospital

Other

Registry information

Official study title

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

Acronym: EPİ-TECH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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