How mother and baby size affects spinal anesthesia spread during cesarean
Preoperative Data and the Spinal Spread of Local Anesthetic in Cesarean Section - a Retrospective Analysis of High Hyperbaric Bupivacaine Dose Cases.
Centre of Postgraduate Medical Education · NCT07197398
This research will see if a fixed spinal anesthetic dose gives different levels of numbness in women having a cesarean depending on the mother's and baby's size.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 140 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Centre of Postgraduate Medical Education (other) |
| Locations | 1 site (Warsaw) |
| Trial ID | NCT07197398 on ClinicalTrials.gov |
What this trial studies
This observational study records maternal and fetal measurements before term cesarean deliveries performed with a standardized spinal dose of 12.5 mg hyperbaric bupivacaine. Investigators will measure the maximal sensory block level after spinal anesthesia and correlate it with maternal anthropometrics (height, weight, BMI, weight gain, abdominal circumference) and newborn size. Cases using a different dose or agent, failed spinal anesthesia, or incomplete records will be excluded. Statistical and subgroup analyses will determine whether the same ED95-based dose yields consistent block heights across body sizes.
Who should consider this trial
Good fit: Term pregnant women scheduled for cesarean under spinal anesthesia with ASA physical status <3 and BMI <40 who receive 12.5 mg hyperbaric bupivacaine are ideal candidates.
Not a fit: Patients who receive a different spinal dose or local anesthetic, have a failed spinal, have poor anesthetic records, or have BMI ≥40 are unlikely to benefit from these results.
Why it matters
Potential benefit: If successful, the findings could help tailor spinal dosing to reduce under- or over-block and improve maternal comfort and safety during cesarean.
How similar studies have performed: Previous studies have reported mixed results, with some finding links between body size and block height and others finding no clear relationship, so the question remains unresolved.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Cesarean delivery at term under spinal anesthesia * American Society of Anesthesiologists (ASA) physical status \<3 * BMI\<40 Exclusion Criteria: * Spinal anesthesia with the dose different than 12.5mg of hyperbaric bupivacaine * Local anesthetic other than hyperbaric bupivacaine used * Failed spinal anesthesia * Poor quality of anesthetic record - required data not available
Where this trial is running
Warsaw
- Centre of Postgraduate Medical Education,Department of Anesthesia and Intensive Care — Warsaw, Poland (RECRUITING)
Study contacts
- Study coordinator: Bartosz Horosz, MD,PhD
- Email: barhorosz@wp.pl
- Phone: 0048225841122
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.
Conditions: Spinal Anesthesia Evaluation, Cesarean Delivery, spinal anesthesia, cesarean section, spinal dose, spinal block level