Trial Outcomes & Findings for ED90 for Hyperbaric Bupivacaine in Super Obese Parturients (NCT NCT03781388)
NCT ID: NCT03781388
Last Updated: 2026-04-17
Results Overview
Bilateral T6 sensory level to pinprick
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
45 participants
Primary outcome timeframe
10 minutes after intrathecal drug administration
Results posted on
2026-04-17
Participant Flow
Three participants were excluded: one had an inadvertent dural puncture, one underwent a trial of labor, and one had a planned vertical skin incision.
Participant milestones
| Measure |
Bupivacaine - 9.75 mg
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.
|
Bupivacaine - 10.5 mg
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.
|
Bupivacaine - 11.25 mg
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.
|
Bupivacaine - 12 mg
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
27
|
11
|
|
Overall Study
COMPLETED
|
1
|
3
|
27
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
Baseline characteristics by cohort
| Measure |
Bupivacaine - 9.75 mg
n=1 Participants
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.
|
Bupivacaine - 10.5 mg
n=3 Participants
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.
|
Bupivacaine - 11.25 mg
n=27 Participants
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.
|
Bupivacaine - 12 mg
n=11 Participants
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.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
27 Participants
n=130 Participants
|
11 Participants
n=392 Participants
|
42 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
27 Participants
n=130 Participants
|
11 Participants
n=392 Participants
|
42 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=130 Participants
|
1 Participants
n=132 Participants
|
14 Participants
n=130 Participants
|
7 Participants
n=392 Participants
|
23 Participants
n=65 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=130 Participants
|
2 Participants
n=132 Participants
|
13 Participants
n=130 Participants
|
4 Participants
n=392 Participants
|
19 Participants
n=65 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=130 Participants
|
0 Participants
n=132 Participants
|
0 Participants
n=130 Participants
|
0 Participants
n=392 Participants
|
0 Participants
n=65 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=130 Participants
|
3 Participants
n=132 Participants
|
27 Participants
n=130 Participants
|
11 Participants
n=392 Participants
|
42 Participants
n=65 Participants
|
PRIMARY outcome
Timeframe: 10 minutes after intrathecal drug administrationPopulation: All participants who received an optimized dose of Bupivacaine and completed the study.
Bilateral T6 sensory level to pinprick
Outcome measures
| Measure |
Bupivacaine - 9.75 mg
n=1 Participants
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.
|
Bupivacaine - 10.5 mg
n=3 Participants
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.
|
Bupivacaine - 11.25 mg
n=27 Participants
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.
|
Bupivacaine - 12 mg
n=11 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Successful Blocks for Induction (Success Induction)
|
1 Participants
|
3 Participants
|
27 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: during surgery up to 90 minutes after intrathecal injectionPopulation: All participants who received an optimized dose of Bupivacaine and completed the study.
Successful initial sensory level without requiring additional epidural anesthetic
Outcome measures
| Measure |
Bupivacaine - 9.75 mg
n=1 Participants
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.
|
Bupivacaine - 10.5 mg
n=3 Participants
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.
|
Bupivacaine - 11.25 mg
n=27 Participants
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.
|
Bupivacaine - 12 mg
n=11 Participants
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.
|
|---|---|---|---|---|
|
Number of Participants With Successful Blocks for Operation (Success Operation)
|
0 Participants
|
2 Participants
|
21 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 90 minutesPopulation: All participants who received an optimized dose of Bupivacaine and completed the study. It was necessary to combine the dosage groups to determine the ED90 of intrathecal bupivacaine for Cesarean delivery.
Outcome measures
| Measure |
Bupivacaine - 9.75 mg
n=42 Participants
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.
|
Bupivacaine - 10.5 mg
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.
|
Bupivacaine - 11.25 mg
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.
|
Bupivacaine - 12 mg
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.
|
|---|---|---|---|---|
|
ED90 (90% Effective Dose) of Intrathecal Bupivacaine for Cesarean Delivery
|
11.56 mg
Interval 11.16 to 11.99
|
—
|
—
|
—
|
Adverse Events
Bupivacaine - 9.75 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine - 10.5 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine - 11.25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine - 12 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place