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ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03781388
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Spinal Anesthesia Cesarean Delivery Drug: Bupivacaine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 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).
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: Blinded study drugs will be prepared by an anesthesia provider not involved in the study. The anesthesia provider providing care to the patient will be blinded to the dosage of the hyperbaric bupivacaine. In order to preserve the blinding of the provider, the total volume of study drug will be maintained at a constant of 2mL. The difference in total volume based on the variation of hyperbaric bupivacaine dosing will be replaced with preservative free normal saline.
Primary Purpose: Treatment
Official Title: ED90 for Hyperbaric Bupivacaine in Spinal Anesthesia for Cesarean Delivery in Super Obese Parturients
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Starting dose of Bupivacaine (9 mg)
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).
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.

Experimental: Subsequent dose 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.




Primary Outcome Measures :
  1. Percent of successful blocks for induction (success induction) [ Time Frame: 10 minutes after intrathecal drug administration ]
    bilateral T6 sensory level to pinprick by

  2. Percent of 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781388


Contacts
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Contact: Ashraf S Habib, MD 9196682024 ashraf.habib@duke.edu
Contact: Emily Z Barney, BS 9709031869 emily.barney@duke.edu

Locations
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United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27705
Contact: Ashraf S Habib, MD    919-668-2024    ashraf.habib@duke.edu   
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Ashraf S Habib, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03781388    
Other Study ID Numbers: Pro00101530
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Bupivacaine ED90
Cesarean Delivery
Obesity
Spinal Anesthesia
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents