ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

Obesity, Morbid Clinical Trial

Official title:

ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781388
• Other study ID #: Pro00101530
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2019
• Est. completion date: December 6, 2022

Study information

• Verified date: January 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 6, 2022
• Est. primary completion date: December 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Delivery
• Obesity, Morbid
• Spinal Anesthesia

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of successful blocks for induction (success induction)	bilateral T6 sensory level to pinprick by	10 minutes after intrathecal drug administration
Primary	Percent of successful blocks for operation (success operation)	successful initial sensory level without requiring additional epidural anesthetic	during surgery up to 90 minutes after intrathecal injection