Epidural Catheter Placement Techniques by Anesthesia Residents: Success and Complications

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorMarmara University Pendik Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • epidural catheter placement

    Procedure/Surgery

    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.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: Loss of Resistance (LOR) Group1 intervention
Group B: Hanging Drop (HD) Group1 intervention

Trial outcomes

Primary outcomes

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.

Time frame
Time Frame: Immediately upon procedure completion

Secondary outcomes

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

Time frame
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.

Time frame
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

Time frame
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

Time frame
intraoperative

Other outcomes

Sponsors and contacts

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