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

NCT07269184 | Not Yet Recruiting

• 1 other identifier: 2025-SEAH-BC-EA-palpation
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Spinous processes are palpable, but interspinous spaces are not clearly identifiable
2. 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. 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.

Conditions

Epidural Analgesia; Ultrasound Assistance

Keywords

epidural; ultrasound; non-palpable spinous processes

Outcome Measures

Primary Outcomes (1)

• first-attempt success rate

  3 months

Study Arms (2)

Ultrasonography (U)

ACTIVE COMPARATOR

Procedure: epidural catheter, ultrasonography

Palpation (P)

ACTIVE COMPARATOR

Procedure: anatomic landmark, epidural cateterisation

Interventions

epidural catheter, ultrasonography PROCEDURE

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.

Ultrasonography (U)

anatomic landmark, epidural cateterisation PROCEDURE

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

Palpation (P)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asist. Doctor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11