ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

Duke University

Status and phase: Completed; Phase 4

Conditions: Spinal Anesthesia; Cesarean Delivery; Obesity, Morbid

Treatments: Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03781388

Pro00101530

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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45 participants in 2 patient groups

Starting dose of Bupivacaine (9 mg)

Experimental group

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).

Treatment:

Drug: Bupivacaine

Subsequent dose

Experimental group

Treatment:

Drug: Bupivacaine