Phase 4
N=42
ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
Obesity, Morbid · Spinal Anesthesia · Cesarean Delivery
Bottom Line
View on ClinicalTrials.gov: NCT03781388 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants With Successful Blocks for Induction (Success Induction) — 1; 3; 27; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Bupivacaine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Duke University
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Blocks for Induction (Success Induction) |
1; 3; 27; 11 | — |
| PRIMARY Number of Participants With Successful Blocks for Operation (Success Operation) |
0; 2; 21; 11 | — |
| PRIMARY ED90 (90% Effective Dose) of Intrathecal Bupivacaine for Cesarean Delivery |
11.56 | — |
Summary
The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.
Eligibility Criteria
Inclusion Criteria
- American Society of Anesthesiology (ASA) class 2 and 3
- English speaking
- Gestational age > 36 weeks
- Scheduled for cesarean delivery under combined spinal epidural anesthesia
- 18 years or older
- BMI > 50 kg/m2
Exclusion Criteria
- History of past or current intravenous drug or chronic opioid abuse
- Allergy or contraindication to any study medications
- Intrapartum cesarean delivery under epidural anesthesia
- Cesarean delivery under general anesthesia
Data sourced from ClinicalTrials.gov (NCT03781388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.