ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients
Overview
- Phase
- Phase 4
- Intervention
- Bupivacaine
- Conditions
- Obesity, Morbid
- Sponsor
- Duke University
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Percent of successful blocks for operation (success operation)
- Status
- Completed
- Last Updated
- 15 days ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Starting dose of Bupivacaine (9.75 mg)
The starting dose of hyperbaric bupivacaine for the first patient in this study will be 9.75mg; 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).
Intervention: Bupivacaine
Subsequent dose
Intervention: Bupivacaine
Outcomes
Primary Outcomes
Percent of successful blocks for operation (success operation)
Time Frame: during surgery up to 90 minutes after intrathecal injection
successful initial sensory level without requiring additional epidural anesthetic
Percent of successful blocks for induction (success induction)
Time Frame: 10 minutes after intrathecal drug administration
bilateral T6 sensory level to pinprick by
Number of Participants With Successful Blocks for Induction (Success Induction)
Time Frame: 10 minutes after intrathecal drug administration
Bilateral T6 sensory level to pinprick
Number of Participants With Successful Blocks for Operation (Success Operation)
Time Frame: 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
Time Frame: 90 minutes