Cesarean Delivery, Obesity, Morbid, Spinal Anesthesia
Conditions
Keywords
Bupivacaine ED90, Cesarean Delivery, Obesity, Spinal Anesthesia
Brief 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.
Interventions
DRUGBupivacaine
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.
Sponsors
Duke University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Blinded study drugs will be prepared by an anesthesia provider not involved in the study. The anesthesia provider providing care to the patient will be blinded to the dosage of the hyperbaric bupivacaine. In order to preserve the blinding of the provider, the total volume of study drug will be maintained at a constant of 2.05mL. The difference in total volume based on the variation of hyperbaric bupivacaine dosing will be replaced with preservative free normal saline.
Intervention model description
The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9mg; the dose for the subsequent subject will be based on the response of the preceding subject as per the Narayana Rule, a modification of the biased-coin design (BCD) up-down sequential method (UDM).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Blocks for Induction (Success Induction) | 10 minutes after intrathecal drug administration | Bilateral T6 sensory level to pinprick |
| Number of Participants With Successful Blocks for Operation (Success Operation) | during surgery up to 90 minutes after intrathecal injection | Successful initial sensory level without requiring additional epidural anesthetic |
| ED90 (90% Effective Dose) of Intrathecal Bupivacaine for Cesarean Delivery | 90 minutes | — |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAshraf S Habib, MD
Duke University
Participant flow
Pre-assignment details
Three participants were excluded: one had an inadvertent dural puncture, one underwent a trial of labor, and one had a planned vertical skin incision.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 3 | 0 / 27 | 0 / 11 |
| other Total, other adverse events | 0 / 1 | 0 / 3 | 0 / 27 | 0 / 11 |
| serious Total, serious adverse events | 0 / 1 | 0 / 3 | 0 / 27 | 0 / 11 |
Outcome results
None listed