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

December 5, 2025 updated by: BURCUCAN, Sakarya University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasonography (U)
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.
Active Comparator: Palpation (P)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
first-attempt success rate
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sakarya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-SEAH-BC-EA-palpation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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