Height-based bupivacaine dosing versus a fixed dose for spinal anesthesia during cesarean delivery
Official title: Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study
Run by University Hospital, Caen · NCT05233462 · Data updated 2026-11-12
This trial will test whether giving bupivacaine based on a woman’s height, rather than a standard fixed dose, reduces episodes of low blood pressure during spinal anesthesia for scheduled cesarean sections.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 250 (estimated) |
| Sponsor | University Hospital, Caen Academic / other |
| Locations | 1 site (Caen) |
| Status | Recruiting |
| Started | February 23, 2022 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | July 25, 2025 |
| Trial ID | NCT05233462 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women at term (>35 weeks) who are scheduled for an elective cesarean section and eligible for spinal (intrathecal) anesthesia may qualify for this comparison.
✕Probably not a fit
Women undergoing emergency cesarean, those with pre-eclampsia/eclampsia, on antihypertensive therapy during pregnancy, or with contraindications to spinal anesthesia are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind trial at Caen University Hospital comparing two intrathecal bupivacaine dosing strategies for elective cesarean delivery. One group receives a standardized 10 mg bupivacaine dose with morphine 100 mcg and sufentanil 3 mcg, and the other receives a height-calculated dose (0.05 mg per cm) with the same opioids. The primary outcome is the rate of maternal hypotension, defined as a ≥20% drop in systolic arterial pressure; secondary outcomes include anesthesia efficacy, failure rates, and interventions required to treat hypotension. Eligible participants are term pregnant women (>35 weeks) scheduled for cesarean under spinal anesthesia without contraindications or hypertensive medication use during pregnancy.
Why it matters
Potential benefit: If successful, the height-based dosing approach could lower the frequency and severity of maternal hypotension and related interventions during spinal anesthesia for cesarean delivery.
How similar studies have gone: Some smaller and observational reports suggest lower intrathecal bupivacaine doses can reduce hypotension, but a well-designed randomized, double-blind comparison has been lacking until now.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * scheduled cesarean section with intrathecal anesthesia * term pregnancy \> 35 weeks * signed informed consent Exclusion Criteria: * unscheduled or emergent cesarean section * any contra indication to intrathecal anesthesia * any antihypertensive drug prescribed to control arterial pressure during pregnancy * pre-eclampsia and eclampsia * history of Marfan or Ehlers Danlos disease
Where it's running
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Caen University Hospital
Caen, France Recruiting
Study contacts
- Study coordinator: jean-luc hanouz, M.D, Ph.D
- Email: hanouz-jl@chu-caen.fr
- Phone: 02 31 06 47 36
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.