ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

Phase 4

Completed

• Conditions: Obesity, Morbid; Spinal Anesthesia; Cesarean Delivery
• Interventions: Drug: Bupivacaine

• Registration Number: NCT03781388
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-18
• Study First Submitted QC: 2018-12-18
• Study First Posted: 2018-12-19
• Study Start: 2019-05-01
• Primary Completion: 2022-12-06
• Study Completion: 2022-12-06
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Starting dose of Bupivacaine (9 mg)	Bupivacaine	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).
Subsequent dose	Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Percent of successful blocks for operation (success operation)	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)	10 minutes after intrathecal drug administration	bilateral T6 sensory level to pinprick by

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States