CompletedPhase 4

ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

United States45 participantsStarted 2019-05-01

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Successful Blocks for Induction (Success Induction)

Timeframe: 10 minutes after intrathecal drug administration

Number of Participants With Successful Blocks for Operation (Success Operation)

Timeframe: during surgery up to 90 minutes after intrathecal injection

ED90 (90% Effective Dose) of Intrathecal Bupivacaine for Cesarean Delivery

Timeframe: 90 minutes

Trial details

NCT IDNCT03781388

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-06

Results submitted2023-10-16

View on ClinicalTrials.gov More Obesity, Morbid trials