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Completed

NCT Number: NCT03781388

ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

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.

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Key information

Conditions

Obesity, Morbid Body Weight Cesarean Delivery Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Anesthesia

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Hospital

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

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.

Primary outcomes

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

    Time frame: 10 minutes after intrathecal drug administration

    Bilateral T6 sensory level to pinprick

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

    Time frame: during surgery up to 90 minutes after intrathecal injection

    Successful initial sensory level without requiring additional epidural anesthetic

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

    Time frame: 90 minutes

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2018
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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