Epidural AnalgesiaNCT07269184
Impact of Ultrasound Guidance on Central Neuraxial Block Success in Patients With Non-Palpable Vertebral Anatomy
A study testing epidural catheter, ultrasonography and anatomic landmark, epidural cateterisation in people with Epidural Analgesia and Ultrasound Assistance, run by Sakarya University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epidural Analgesia, Ultrasound Assistance
- What is being tested?
- epidural catheter, ultrasonography and anatomic landmark, epidural cateterisation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Scheduled for elective general surgery
- Planned epidural catheterization
- Aged 18-60 years
- ASA physical status I-III
- Spinous processes not palpable (class3)
Who cannot join
- 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
About this study
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:
Read more
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
- Spinous processes are palpable, but interspinous spaces are not clearly identifiable
- Spinous processes are not palpable, interspinous spaces are not identifiable, but the vertebral column can be palpated either on or off the midline
- 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.
- Conditions
- Epidural Analgesia, Ultrasound Assistance
- Being tested
- epidural catheter, ultrasonography, anatomic landmark, epidural cateterisation
- Keywords
- epidural, ultrasound, non-palpable spinous processes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheter, ultrasonographyProcedure or surgery
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.
anatomic landmark, epidural cateterisationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Ultrasonography (U) | Active comparator | Not described Receives: Procedure: epidural catheter, ultrasonography |
| Palpation (P) | Active comparator | Not described Receives: Procedure: anatomic landmark, epidural cateterisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
first-attempt success rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural AnalgesiaStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, BURCUCAN, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269184
- Sponsor's protocol ID
- 2025-SEAH-BC-EA-palpation
- Status last verified
- Nov 2025
- First submitted
- 25 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound Guidance on Central Neuraxial Block Success in Patients With Non-Palpable Vertebral Anatomy
- ClinicalTrials.gov ID
- NCT07269184
- Acronym / sponsor ID
- 2025-SEAH-BC-EA-palpation
- Conditions
- Epidural Analgesia, Ultrasound Assistance
- Keywords
- epidural, ultrasound, non-palpable spinous processes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Spinous processes are palpable, but interspinous spaces are not clearly identifiable
- Spinous processes are not palpable, interspinous spaces are not identifiable, but the vertebral column can be palpated either on or off the midline
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasonography (U) | Active comparator | Procedure: epidural catheter, ultrasonography |
| Palpation (P) | Active comparator | Procedure: anatomic landmark, epidural cateterisation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Scheduled for elective general surgery
- Planned epidural catheterization
- Aged 18-60 years
- ASA physical status I-III
- Spinous processes not palpable (class3)
Key exclusion criteria (6 listed)
- Contraindication to epidural catheterization
- ASA physical status IV-V
- Diagnosed with scoliosis
- Presence of anatomical deformities
- Declining to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epidural catheter, ultrasonographyIn 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 or surgery | Ultrasonography (U) |
| anatomic landmark, epidural cateterisationIn 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 | Procedure or surgery | Palpation (P) |
Primary outcome
first-attempt success rate
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing epidural catheter, ultrasonography and anatomic landmark, epidural cateterisation in people with Epidural Analgesia and Ultrasound Assistance, run by Sakarya University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
first-attempt success rate (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.