Spinal AnesthesiaNCT06191445
Comparison of the Efficacy of Conventional Landmark, Ultrasound-Assisted, and Real-Time Ultrasound-Guided Techniques in Spinal Anesthesia for Obese Patients
A study testing Conventional Landmark Technique, Ultrasound Assisted Technique and Real-Time Ultrasound Guided Technique in people with Spinal Anesthesia and Ultrasound, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia is frequently administered using the conventional landmark technique. Ultrasound is a non-invasive and safe approach. Neuroaxial anesthesia procedures can be conducted using two different ultrasound techniques; Real-Time Ultrasound Guided (USRTG) and Ultrasound-Assisted (USAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Anesthesia, Ultrasound
- What is being tested?
- Conventional Landmark Technique, Ultrasound Assisted Technique and Real-Time Ultrasound Guided Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2024to 1 Aug 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Patients who will undergo lower extremity orthopedic surgery
- ASA I-II-III patients
- BMI 30 kg/m² and above
Who cannot join
- BMI < 30 kg/m²
- ASA IV-V patients
- Severe cardiovascular disease
- Patients with a known or suspected allergy to local anesthetics
- Contraindications of spinal anesthesia (eg, coagulopathy, puncture site infection)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bursa Uludag University Faculty of Medicine
Bursa, 16059
SELCAN AKESEN, +902242953274, selcanakesen@uludag.edu.tr
Kübra Cebeci
About this study
Official title: Does the Use of Ultrasound Increase Spinal Anesthesia Success for Obese Patients?: Evaluation of the Success of Spinal Anesthesia Administered with Real-Time Ultrasound-Guided, Ultrasound-Assisted and Conventional Landmark Techniques
Spinal anesthesia is frequently administered using the conventional landmark technique. Ultrasound is a non-invasive and safe approach. Neuroaxial anesthesia procedures can be conducted using two different ultrasound techniques; Real-Time Ultrasound Guided (USRTG) and Ultrasound-Assisted (USAS). The primary objective of this study is to compare the successes of spinal anesthesia applications using USRTG, USAS, and conventional landmark techniques on the first attempt in obese patients undergoing orthopedic surgery.
Read the detailed description
Patients included in the study will be those undergoing lower extremity orthopedic surgery, with a body mass index (BMI) 30 kg/m² and above, and classified as American Society of Anesthesiologists (ASA) class I-III. Patients will be randomized into 3 groups. In the Conventional Landmark group, spinal anesthesia will be administered using the conventional technique. In the Ultrasound-Assisted group, the spinal space will be marked with ultrasound before proceeding. For the Real-Time Ultrasound-Guided group, the spinal space and the advancement of the needle for the injection will be visualized simultaneously with ultrasound during the application of spinal anesthesia. The primary outcome is to compare the success rates on the first attempt. The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction
- Conditions
- Spinal Anesthesia, Ultrasound
- Being tested
- Conventional Landmark Technique, Ultrasound Assisted Technique, Real-Time Ultrasound Guided Technique
- Keywords
- Anesthesia, Spinal Anesthesia, Obesity, Ultrasonography
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Landmark TechniqueProcedure or surgery
The investigator will perform spinal anesthesia using the conventional landmark technique.
Ultrasound Assisted TechniqueProcedure or surgery
The investigator will perform spinal anesthesia using the ultrasound assisted technique.
Real-Time Ultrasound Guided TechniqueProcedure or surgery
The investigator will perform spinal anesthesia using the real-time ultrasound-guided technique.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Landmark Group | Active comparator | The investigator will perform spinal anesthesia using the conventional landmark technique. Receives: Procedure: Conventional Landmark Technique |
| USAS Group | Active comparator | The investigator will perform spinal anesthesia using ultrasound-assisted technique. Receives: Procedure: Ultrasound Assisted Technique |
| US-RTG Group | Active comparator | The investigator will perform spinal anesthesia using real-time ultrasound-guided technique. Receives: Procedure: Real-Time Ultrasound Guided Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rates on the first attempt.
The primary outcome is to compare the success rates on the first attempt.
Measured: Preoperatively
Secondary outcomes (1)
Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction
The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications (radicular pain, postdural puncture headache, hematoma, paresthesia) and patient satisfaction.
Needle redirection was defined as any change in needle insertion trajectory not involving complete withdrawal of the needle from the patient's skin.
Procedure time was defined as the total duration from the placement of the probe on the skin to the completion of skin marking and from the insertion of the needle into the skin to the observation of cerebrospinal fluid (CSF) outflow using the designated technique.
Patient satisfaction will be evaluated on a scale of 1 to 5 (1:extremely unsatisfied; 5:extremely satisfied).
Measured: Preoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selcan Akesen, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191445
- Sponsor's protocol ID
- UludagU-KCebeci-002
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2023
- Last updated
- 16 Oct 2024
- 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 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of Ultrasound Increase Spinal Anesthesia Success for Obese Patients?: Evaluation of the Success of Spinal Anesthesia Administered with Real-Time Ultrasound-Guided, Ultrasound-Assisted and Conventional Landmark Techniques
- ClinicalTrials.gov ID
- NCT06191445
- Acronym / sponsor ID
- UludagU-KCebeci-002
- Conditions
- Spinal Anesthesia, Ultrasound
- Keywords
- Anesthesia, Spinal Anesthesia, Obesity, Ultrasonography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 5 Jan 2024 (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.
Spinal anesthesia is frequently administered using the conventional landmark technique. Ultrasound is a non-invasive and safe approach. Neuroaxial anesthesia procedures can be conducted using two different ultrasound techniques; Real-Time Ultrasound Guided (USRTG) and Ultrasound-Assisted (USAS). The primary objective of this study is to compare the successes of spinal anesthesia applications using USRTG, USAS, and conventional landmark techniques on the first attempt in obese patients undergoing orthopedic surgery.
Detailed description
Patients included in the study will be those undergoing lower extremity orthopedic surgery, with a body mass index (BMI) 30 kg/m² and above, and classified as American Society of Anesthesiologists (ASA) class I-III. Patients will be randomized into 3 groups. In the Conventional Landmark group, spinal anesthesia will be administered using the conventional technique. In the Ultrasound-Assisted group, the spinal space will be marked with ultrasound before proceeding. For the Real-Time Ultrasound-Guided group, the spinal space and the advancement of the needle for the injection will be visualized simultaneously with ultrasound during the application of spinal anesthesia. The primary outcome is to compare the success rates on the first attempt. The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Landmark Group | Active comparator | Procedure: Conventional Landmark TechniqueThe investigator will perform spinal anesthesia using the conventional landmark technique. |
| USAS Group | Active comparator | Procedure: Ultrasound Assisted TechniqueThe investigator will perform spinal anesthesia using ultrasound-assisted technique. |
| US-RTG Group | Active comparator | Procedure: Real-Time Ultrasound Guided TechniqueThe investigator will perform spinal anesthesia using real-time ultrasound-guided technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Patients who will undergo lower extremity orthopedic surgery
- ASA I-II-III patients
- BMI 30 kg/m² and above
Key exclusion criteria (5 listed)
- BMI < 30 kg/m²
- ASA IV-V patients
- Severe cardiovascular disease
- Patients with a known or suspected allergy to local anesthetics
- Contraindications of spinal anesthesia (eg, coagulopathy, puncture site infection)
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 |
|---|---|---|
| Conventional Landmark TechniqueThe investigator will perform spinal anesthesia using the conventional landmark technique. | Procedure or surgery | Conventional Landmark Group |
| Ultrasound Assisted TechniqueThe investigator will perform spinal anesthesia using the ultrasound assisted technique. | Procedure or surgery | USAS Group |
| Real-Time Ultrasound Guided TechniqueThe investigator will perform spinal anesthesia using the real-time ultrasound-guided technique. | Procedure or surgery | US-RTG Group |
Primary outcome
Success rates on the first attempt.
Time frame: Preoperatively
The primary outcome is to compare the success rates on the first attempt.
1 secondary outcome
Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction
Time frame: Preoperatively
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 16 Oct 2024.
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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.
Bursa Uludag University Faculty of Medicine
Bursa, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Landmark Technique, Ultrasound Assisted Technique and Real-Time Ultrasound Guided Technique in people with Spinal Anesthesia and Ultrasound, run by Uludag 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 5 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 16 Oct 2024. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rates on the first attempt. (time frame: Preoperatively). 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 16 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.