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Not yet recruiting NCT07269184

Impact of Ultrasound Guidance on Central Neuraxial Block Success in Patients With Non-Palpable Vertebral Anatomy

No phase Interventional Epidural Analgesia Ultrasound Assistance

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: epidural catheter, ultrasonography, anatomic landmark, epidural cateterisation.
Who it may be relevant to
Registry conditions: Epidural Analgesia, Ultrasound Assistance. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Patients scheduled to undergo general surgery with planned epidural catheter placement will be evaluated by comparing two different techniques routinely used in anesthesia practice for catheter insertion. A total of 60 patients aged 18-60 years, classified as ASA I-III, and scheduled to undergo general surgical procedures with epidural catheter placement at Sakarya University Faculty of Medicine Training and Research Hospital will be included in the study. All patients will be classified according to the following palpation scoring system to assess the difficulty of vertebral palpation: Palpation Score: All patients will be evaluated in the sitting position, and the difficulty of palpating vertebral landmarks will be scored between 0 and 3: 0: Spinous processes and interspinous spaces are clearly identifiable 1. Spinous processes are palpable, but interspinous spaces are not clearly identifiable 2. Spinous processes are not palpable, interspinous spaces are not identifiable, but the vertebral column can be palpated either on or off the midline 3. Spinous processes and interspinous spaces are not palpable, and vertebral structures are not clearly distinguishable Patients with a palpation score of 3 will be included in the study group. Patients with a score of 0 will be included as the control group. Patients will be divided into two groups: Anatomical Landmark Group and Ultrasound Group. In the Ultrasound Group, surface marking will be performed in the operating room using ultrasonography. In the Anatomical Landmark Group, after the patient is positioned sitting in the operating room, the insertion site will be estimated by palpation of anatomical landmarks. After determining the needle entry point in both groups, epidural catheterization will be performed under sterile conditions according to our routine practice. The two groups will be compared in terms of first-attempt success rate, total procedure time, number of needle redirections, and complications occurring during the procedure.

Interventions

  • Procedure epidural catheter, ultrasonography
    In the Ultrasound Group, surface marking will be performed in the operating room using ultrasonography. In the Anatomical Landmark Group, after the patient is positioned sitting in the operating room, the insertion site will be estimated by palpation of anatomical landmarks.
  • Procedure anatomic landmark, epidural cateterisation
    In the palpation group, after the patients are brought into the operating room and positioned sitting, the needle insertion site for epidural catheter placement will be determined by manual palpation

Primary outcome measures

  • first-attempt success rate [Time frame: 3 months]

Eligibility criteria

Inclusion criteria

  • Scheduled for elective general surgery
  • Planned epidural catheterization
  • Aged 18-60 years
  • ASA physical status I-III
  • Spinous processes not palpable (class3)

Exclusion criteria

  • Contraindication to epidural catheterization
  • ASA physical status IV-V
  • Diagnosed with scoliosis
  • Presence of anatomical deformities
  • Declining to participate in the study
  • Patients for whom follow-up conditions cannot be ensured

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07269184 · 2025-SEAH-BC-EA-palpation

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗