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 range18 Years – 45 Years

SexFEMALE

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

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

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