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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
epidural catheter placement
Procedure/SurgeryEpidural 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
Trial outcomes
Primary outcomes
First-attempt success rate
Defined as successful epidural space identification and catheter placement in a single Tuohy needle insertion attempt, without redirecting the needle.
Secondary outcomes
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
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.
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
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
Sponsors and contacts
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