CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 45 enrolled
Drug / intervention
Bupivacainedrug
Likely dose
Bupivacaine 0.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03781388
NCT03781388Phase 4Completed
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ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients

Duke University·interventional·Posted Dec 19, 2018·Updated Apr 17, 2026

In Brief

A Phase 4 clinical trial evaluating Bupivacaine for Obesity, Morbid and 2 related conditions. Completed, enrolled 45 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Morbid, Spinal Anesthesia, Cesarean Delivery
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedDec 19, 2018
Enrollment StartMay 1, 2019
Primary CompletionDec 6, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.5 years ago

Interventions

Bupivacainedrug

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.