ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

PHASE4CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

May 1, 2019

Primary Completion Date

December 6, 2022

Study Completion Date

December 6, 2022

Conditions
Obesity, MorbidSpinal AnesthesiaCesarean Delivery
Interventions
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.

Trial Locations (1)

27705

Duke University Hospital, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER