Comparing ultrasound and landmark methods for spinal anesthesia in super obese pregnant women
Comparison of Ultrasound and Anatomical Landmark Method in Spinal Anesthesia for Elective Cesarean Section in Super Obese Parturients With BMI ≥ 50 kg/m2. A Randomized Controlled Trial
This study tests whether using ultrasound to give spinal anesthesia works better than the traditional method for super obese pregnant women having cesarean sections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Karaman Training and Research Hospital Academic / other |
| Locations | 1 site (Karaman) |
| Trial ID | NCT06410820 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of an ultrasound-assisted technique versus a traditional landmark method for administering spinal anesthesia in super obese pregnant women with a BMI of 50 or higher who are undergoing elective cesarean sections. The primary goal is to determine the success rate of the dural puncture on the first attempt. The study will be conducted at a single university hospital, where trained anesthetists will perform the procedures while remaining blinded to the group assignments. The research aims to improve the accuracy and efficiency of spinal anesthesia in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women with a BMI of 50 or higher scheduled for elective cesarean delivery under spinal anesthesia.
Not a fit: Patients who may not benefit from this study include those with a BMI below 50, multiple gestations, or contraindications to spinal anesthesia.
Why it matters
Potential benefit: If successful, this study could enhance the success rate of spinal anesthesia in super obese parturients, leading to safer and more effective cesarean deliveries.
How similar studies have performed: While the use of ultrasound in spinal anesthesia is gaining traction, this specific approach in super obese parturients is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Parturient who will receive selective cesarean delivery under spinal anesthesia * ASA 3 scheduled for elective sections * BMI≥50 kg/m2 * Normal singleton pregnancy * 37 weeks of gestation Exclusion Criteria: * Multiple gestations * Emergency C-section * Exist contraindications of spinal anesthesia * Local anesthetics allergy * BMI\<50 kg/m2 * History of lumbar spinal diseases and lumbar surgery * Parturient refusal
Where this trial is running
Karaman
- Karaman Training and Research Hospital — Karaman, Turkey (Recruiting)
Study contacts
- Principal investigator: Ayşegül Bilge, MD — Karaman TRH
- Study coordinator: Betul Basaran, MD,DESA
- Email: betulbasaran1@yahoo.com
- Phone: +903382263000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.