NCT03781388

ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity, Morbid
• Spinal Anesthesia
• Cesarean Delivery

Interventions

Type	Name	Description
DRUG	Bupivacaine	Determination of the dose will rely on the outcomes of the preceding 7 patients receiving the same dose, as the number of previous patients to consider is a function of the target dose. Among all patients who received a certain dose, a proportion of successful outcomes will be determined (P(d)); if P(d) \<0.90, and at least one of the previous 7 patients who received the same dose had an unsatisfactory outcome, the next patient will receive a pre-determined increment of 0.75 mg of bupivacaine. Alternatively, if P(d) 0.90 and the previous 7 patients who received the same dose had successful outcomes, the next patient will receive a pre-determined decrement of 0.75mg of bupivacaine. Otherwise, the dose will remain the same.

Timeline

• Start date: 2019-05-01
• Primary completion: 2022-12-06
• Completion: 2022-12-06
• First posted: 2018-12-19
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study