Morbid ObesityNCT05342922
The Ultrasound Guided Versus Land-mark Location Method for Performing Spinal Anesthesia in Obese Parturients
A study testing Ultrasound group and Landmark group in people with Morbid Obesity, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Ultrasound group and Landmark group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 May 2022to 24 Jan 2023
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Parturient who will receive selective cesarean delivery under spinal anesthesia
- ASA 2-3 scheduled for elective sections
- BMI≥40 kg/m2
- normal singleton pregnancy
- ≥37 weeks of gestation
Who cannot join
- Multiple gestations
- Emergency C-section
- exist contraindications of spinal anesthesia
- Local anesthetics allergy
- BMI<40 kg/m2
- history of lumbar spinal diseases and lumbar surgery
- Parturient refusal
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Comparison of Ultrasound and Anatomical Land-mark Method in Spinal Anesthesia for Elective Cesarean Section in Obese Parturients With BMI ≥ 40 kg/m2. A Randomized Controlled Trial
This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section.
The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.
Read the detailed description
Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may have difficulties in determining the poorly palpable surface landmarks in morbidly obese pregnant women.
Manual palpation technique, which is preferred in neuraxial anesthesia, may be difficult in obese pregnant women due to the difficulty in identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease number of attempts in obese parturients.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. Patient, the anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups.Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 150 ultrasound-guided neuraxial blocks.
- Conditions
- Morbid Obesity
- Being tested
- Ultrasound group, Landmark group
- Keywords
- Spinal Anesthesia, Cesarean Delivery, Ultrasound
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound groupProcedure or surgery
In the operating room, all of the patients will receive standard monitoring. Scans will be made in logiditunal parasagittal and transverse midline views with ultrasound. Needle entry sites in the L2-L3 and L3-L4 intervals will be determined as the intersection of the longiditunal and transverse lines.
When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.
Landmark groupProcedure or surgery
In the Landmark group, the injection site will be determined using the traditional method of palpating the posterior superior iliac spine.When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound group | Active comparator | Ultrasound assited technique will be used for spinal anesthesia performance. Receives: Procedure: Ultrasound group |
| Landmark group | Experimental | Land-mark assisted technique will be used for spinal anesthesia performance. Receives: Procedure: Landmark group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success rate of first puncture
Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.
Measured: 30 minute
Secondary outcomes (12)
Number of skin punctures
Skin puncture is defined as any separate skin puncture attempt.
Measured: 30 minute
Number of needle pass
Needle pass is defined as skin puncture plus number of redirection attempts
Measured: 30 minute
The procedure duration time
The duration from initiation of location marking by palpation or ultrasound to obtaining free cerebrospinal fluid flow
Measured: 30 minute
Time interval to determine needle insertion site
Time interval between the operator touches the parturient and the completion of the needle insertion point marking
Measured: 30 minute
Time taken for spinal injection
The time interval between the needle insertion to visualization of cerebrospinal spinal fluid in the spinal needle.
Measured: 30 minute
Number of puncture levels
Move to a second lumbar space after 3 needle insertion attempts
Measured: 30 minute
Patient satisfaction The procedure duration
Patients rated their satisfaction as very satisfied, satisfied, or dissatisfied immediately after the procedure.
Measured: 30 minute
incidence of complications during puncture
Incidence of radicular pain, paresthesia, and blood during spinal needle injection
Measured: 30 minute
incidence of postoperative headache
12-72 hours following spinal anesthesia due to CSF leakage
Measured: 72 hour
Incidence of hypotension
A systolic arterial pressure decrease of more than 25% from baseline or less than 90 mmHg
Measured: 2 hour
Failure rate of spinal anesthesia
Number of parturients who need additional analgesic drug or conversion to general anesthesia
Measured: 120 minute
dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ]
thoracic dermatome level of sensory block assessed by pinprick test
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start23 May 2022
- Primary completion23 Jan 2023
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betul Basaran, MD,DESA, Study director, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342922
- Sponsor's protocol ID
- 02-2022/02
- Status last verified
- Apr 2022
- First submitted
- 18 Apr 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bilge A, Basaran B. Ultrasound-assisted technique versus the conventional landmark location method in spinal anesthesia for cesarean delivery in parturients with class 3 obesity: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 1;25(1):305. doi: 10.1186/s12871-025-03176-x.
PubMed 40596815
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound and Anatomical Land-mark Method in Spinal Anesthesia for Elective Cesarean Section in Obese Parturients With BMI ≥ 40 kg/m2. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05342922
- Acronym / sponsor ID
- 02-2022/02
- Conditions
- Morbid Obesity
- Keywords
- Spinal Anesthesia, Cesarean Delivery, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 23 May 2022 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 25 Apr 2022 (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.
This study will be investigated whether an ultrasound-assisted technique is better than a classical land-mark technique to facilitate spinal anesthesia in the lateral position in morbidly obese pregnant women with BMI ≥ 40 who will undergo elective cesarean section.
The primary objective in this study is the rate of successful dural puncture at the first attempt. It was assumed that ultrasound could facilitate neuraxial blockade in grade 3 morbidly obese pregnant women according to the Who classification, whose topographic anatomy is difficult.
Detailed description
Spinal anesthesia is the most commonly used anesthesia method for elective cesarean deliveries. Anesthesiologists may have difficulties in determining the poorly palpable surface landmarks in morbidly obese pregnant women.
Manual palpation technique, which is preferred in neuraxial anesthesia, may be difficult in obese pregnant women due to the difficulty in identifying bone landmarks. Neuraxial ultrasound examination before spinal anesthesia may help spinal anesthesia performance and decrease number of attempts in obese parturients.
This study will be conducted as a single-center, prospective, randomized, double-blinded trial in a university hospital. Patients scheduled for elective cesarean will be screened for enrollment in the study. Patient, the anesthetist administering spinal anesthesia and evaluating the data were blind to the distribution of patient groups.Ultrasonographic examinations were performed by a single investigator trained in this technique who performed more than 150 ultrasound-guided neuraxial blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Allocation: Randomized Intervention Model: Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Ultrasound group | Active comparator | Procedure: Ultrasound groupUltrasound assited technique will be used for spinal anesthesia performance. |
| Landmark group | Experimental | Procedure: Landmark groupLand-mark assisted technique will be used for spinal anesthesia performance. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Parturient who will receive selective cesarean delivery under spinal anesthesia
- ASA 2-3 scheduled for elective sections
- BMI≥40 kg/m2
- normal singleton pregnancy
- ≥37 weeks of gestation
Key exclusion criteria (7 listed)
- Multiple gestations
- Emergency C-section
- exist contraindications of spinal anesthesia
- Local anesthetics allergy
- BMI<40 kg/m2
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 |
|---|---|---|
| Ultrasound groupIn the operating room, all of the patients will receive standard monitoring. Scans will be made in logiditunal parasagittal and transverse midline views with ultrasound. Needle entry sites in the L2-L3 and L3-L4 intervals will be determined as the intersection of the longiditunal and transverse lines. When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine. | Procedure or surgery | Ultrasound group |
| Landmark groupIn the Landmark group, the injection site will be determined using the traditional method of palpating the posterior superior iliac spine.When the spinal puncture operator is outside the room, Needle entry sites were marked for both groups.After skin marking, the pregnant woman will be asked to remain still and a subarachnoid puncture will be performed immediately. Spinal anesthesia will be administered with injection of intrathecal bupivacaine. | Procedure or surgery | Landmark group |
Primary outcome
The success rate of first puncture
Time frame: 30 minute
Success on a single-puncture attempt will be defined as reaching the subarachnoid space on the first insertion of the needle.
12 secondary outcomes
Number of skin punctures
Time frame: 30 minute
Number of needle pass
Time frame: 30 minute
The procedure duration time
Time frame: 30 minute
Time interval to determine needle insertion site
Time frame: 30 minute
Time taken for spinal injection
Time frame: 30 minute
Number of puncture levels
Time frame: 30 minute
Patient satisfaction The procedure duration
Time frame: 30 minute
incidence of complications during puncture
Time frame: 30 minute
incidence of postoperative headache
Time frame: 72 hour
Incidence of hypotension
Time frame: 2 hour
Failure rate of spinal anesthesia
Time frame: 120 minute
dermatome level of sensory block [ Time Frame: 10 minutes after spinal anesthetic injection ]
Time frame: 20 minute
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 25 Jan 2023.
- Derived from this study: PubMed 40596815Bilge A, Basaran B. Ultrasound-assisted technique versus the conventional landmark location method in spinal anesthesia for cesarean delivery in parturients with class 3 obesity: a randomized controlled trial. BMC Anesthesiol. 2025 Jul 1;25(1):305. doi: 10.1186/s12871-025-03176-x.
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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. This study is not recruiting at the moment.
Betul Basaran, MD,DESA study director
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound group and Landmark group in people with Morbid Obesity, run by Karaman Training and Research Hospital 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 5 inclusion and 7 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 25 Jan 2023. 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?
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?
The success rate of first puncture (time frame: 30 minute). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05342922, which also lists 1 linked publication.
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 25 Jan 2023.