Obesity (Body Mass Index >30 kg/m2)NCT06987240
Landmark vs Ultrasound For Combined Spinal Epidural
A study testing Ultrasonography-guided combined spinal epidural anesthesia application and Combined spinal epidural anesthesia with Landmark in people with Obesity (Body Mass Index >30 kg/m2) and Ultrasonography, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
A comparison of two different methods used in routine anesthesia practices will be made for the insertion of a catheter that will be placed at the waist for anesthesia in obese patients who will undergo orthopedic surgery. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Obesity (Body Mass Index >30 kg/m2), Ultrasonography, Combined Spinal Epidural Anesthesia
- What is being tested?
- Ultrasonography-guided combined spinal epidural anesthesia application and Combined spinal epidural anesthesia with Landmark
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA II-III
- BMI>30
- Elective orthopedic lower extremity surgery
- Combined spinal epidural anesthesia (CSEA)
Who cannot join
- Patients with CSEA contraindication
- ASA IV-V
- Diagnosed with scoliosis
- Patients with anatomical disorders
- Patients who did not agree to participate in the study
- Patients for whom follow-up conditions could not be met
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sakarya University Hospital
Sakarya, Adapazarı, 54100
About this study
Official title: Comparison Of Ultrasound-Assisted Combined Spinal Epidural Procedure With Anatomical Landmark Method In Obese Patients Undergoing Lower Extremity Surgery
A comparison of two different methods used in routine anesthesia practices will be made for the insertion of a catheter that will be placed at the waist for anesthesia in obese patients who will undergo orthopedic surgery.
60 obese patients aged 40-80, ASA II-III, BMI>30, who are planned to undergo elective orthopedic lower extremity surgery by placing a combined spinal epidural catheter at Sakarya University Medical Faculty Education and Research Hospital will be included in the study.
Read more
General anesthesia or regional anesthesia techniques are routinely used in lower extremity surgery in our clinic. When placing a combined spinal epidural catheter, the entry site is determined by looking at anatomical landmarks or using ultrasound.
Patients will be divided into two different groups as Anatomical Marking or Ultrasound.
Patients in the Ultrasound group will be taken to the block room in our operating room before the operation and a location marking will be performed with Ultrasound in the block room.
Patients in the Anatomical Marking group will be brought to a sitting position in the operating room in the operating room and a location marking will be performed by hand examination.
After determining the needle entry site, patients in both groups will undergo the Combined spinal epidural catheter placement procedure, which is performed routinely under sterile conditions, and the success rate at the first attempt, total success rates, number of needle redirections, and complications during the procedure will be compared.
- Conditions
- Obesity (Body Mass Index >30 kg/m2), Ultrasonography, Combined Spinal Epidural Anesthesia
- Being tested
- Ultrasonography-guided combined spinal epidural anesthesia application, Combined spinal epidural anesthesia with Landmark
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography-guided combined spinal epidural anesthesia applicationProcedure or surgery
patients with BMI>30
Combined spinal epidural anesthesia with LandmarkProcedure or surgery
Patients with BMI>30
| Study group | Role | What they receive |
|---|---|---|
| ultrasonography (USG) | Active comparator | In this group, patients will first be marked with ultrasonography and the time required for this procedure will be recorded. Then, the needle will be inserted from the marked area. When performing the combined spinal epidural procedure, the number of needle insertions, the number of directions will be recorded and the time from needle insertion to needle exit will be recorded. Receives: Procedure: Ultrasonography-guided combined spinal epidural anesthesia application |
| Landmark (L) | Placebo comparator | Patients in this group will be marked according to anatomical landmarks. The time from needle entry to exit and the number of needle entries and directions will be recorded. Receives: Procedure: Combined spinal epidural anesthesia with Landmark |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
FIRST TRY SUCCESS; will be defined as FINDING THE EPIDURAL SPACING WITHOUT REMOVING THE NEEDLE FROM THE SKIN.
Measured: up to 20 weeks
Secondary outcomes (3)
Number of needle insertions
Number of referrals after needle intervention
Measured: up to 20 weeks
Time to determine the needle insert
Duration of determination of the needle insertion site by ultrasonography or anatomical landmarks
Measured: up to 20 weeks
Total procedure time
Procedure time: The time from the entry of the Tuohy needle through the skin to the completion of the procedure, placement of the catheter and withdrawal of the needle
Measured: up to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 May 2025
- Primary completion1 Aug 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity (Body Mass Index >30 kg/m2)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987240
- Sponsor's protocol ID
- 2025-SEAH-BC-KSEA
- Status last verified
- Nov 2025
- First submitted
- 22 Apr 2025
- Last updated
- 28 Nov 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 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Ultrasound-Assisted Combined Spinal Epidural Procedure With Anatomical Landmark Method In Obese Patients Undergoing Lower Extremity Surgery
- ClinicalTrials.gov ID
- NCT06987240
- Acronym / sponsor ID
- 2025-SEAH-BC-KSEA
- Conditions
- Obesity (Body Mass Index >30 kg/m2), Ultrasonography, Combined Spinal Epidural Anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 23 May 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.
A comparison of two different methods used in routine anesthesia practices will be made for the insertion of a catheter that will be placed at the waist for anesthesia in obese patients who will undergo orthopedic surgery.
60 obese patients aged 40-80, ASA II-III, BMI>30, who are planned to undergo elective orthopedic lower extremity surgery by placing a combined spinal epidural catheter at Sakarya University Medical Faculty Education and Research Hospital will be included in the study.
General anesthesia or regional anesthesia techniques are routinely used in lower extremity surgery in our clinic. When placing a combined spinal epidural catheter, the entry site is determined by looking at anatomical landmarks or using ultrasound.
Patients will be divided into two different groups as Anatomical Marking or Ultrasound.
Patients in the Ultrasound group will be taken to the block room in our operating room before the operation and a location marking will be performed with Ultrasound in the block room.
Patients in the Anatomical Marking group will be brought to a sitting position in the operating room in the operating room and a location marking will be performed by hand examination.
After determining the needle entry site, patients in both groups will undergo the Combined spinal epidural catheter placement procedure, which is performed routinely under sterile conditions, and the success rate at the first attempt, total success rates, number of needle redirections, and complications during the procedure will be compared.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasonography (USG) | Active comparator | Procedure: Ultrasonography-guided combined spinal epidural anesthesia applicationIn this group, patients will first be marked with ultrasonography and the time required for this procedure will be recorded. Then, the needle will be inserted from the marked area. When performing the combined spinal epidural procedure, the number of needle insertions, the number of directions will be recorded and the time from needle insertion to needle exit will be recorded. |
| Landmark (L) | Placebo comparator | Procedure: Combined spinal epidural anesthesia with LandmarkPatients in this group will be marked according to anatomical landmarks. The time from needle entry to exit and the number of needle entries and directions will be recorded. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA II-III
- BMI>30
- Elective orthopedic lower extremity surgery
- Combined spinal epidural anesthesia (CSEA)
Key exclusion criteria (6 listed)
- Patients with CSEA contraindication
- ASA IV-V
- Diagnosed with scoliosis
- Patients with anatomical disorders
- Patients who did not agree 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 |
|---|---|---|
| Ultrasonography-guided combined spinal epidural anesthesia applicationpatients with BMI>30 | Procedure or surgery | ultrasonography (USG) |
| Combined spinal epidural anesthesia with LandmarkPatients with BMI>30 | Procedure or surgery | Landmark (L) |
Primary outcome
First attempt success rate
Time frame: up to 20 weeks
FIRST TRY SUCCESS; will be defined as FINDING THE EPIDURAL SPACING WITHOUT REMOVING THE NEEDLE FROM THE SKIN.
3 secondary outcomes
Number of needle insertions
Time frame: up to 20 weeks
Time to determine the needle insert
Time frame: up to 20 weeks
Total procedure time
Time frame: up to 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
Related trials for Obesity (Body Mass Index >30 kg/m2)
Active, not recruiting
Effects of a High-protein Diet and Resistance Training on Fat-mass Loss Maintenance
Obesity (Body Mass Index >30 kg/m2)
Active, not recruiting
Virtual Reality Training on Balance, Postural Stability, Mobility and Quality of Life in Obese Patients
Obesity/Therapy, Obesity (Body Mass Index >30 kg/m2)
Active, not recruitingObservational study
A Consumer Health Study Evaluating the Impact of Pivit on Weight Loss and Appetite in Overweight Individuals
Obesity &Amp;Amp;Amp; Overweight, Obesity (Body Mass Index &Amp;Amp;Amp;Amp;gt;30 kg/m2)
RecruitingPhase 3
Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI)
Obesity and Cardiovascular Risk, Insulin Resistance
Not yet recruitingPhase 4
PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder
Attention Deficit Hyperactivity Disorder (ADHD), Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2)
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography-guided combined spinal epidural anesthesia application and Combined spinal epidural anesthesia with Landmark in people with Obesity (Body Mass Index >30 kg/m2) and Ultrasonography, run by Sakarya University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: up to 20 weeks). 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 28 Nov 2025.