ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03781388
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
42.1
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
Phase 4

Study Design

Study Type:
Interventional
Anticipated 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).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
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  1. Percent of successful blocks for induction (success induction) [10 minutes after intrathecal drug administration]

    bilateral T6 sensory level to pinprick by

  2. Percent of successful blocks for operation (success operation) [during surgery up to 90 minutes after intrathecal injection]

    successful initial sensory level without requiring additional epidural anesthetic

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Duke University HospitalDurhamNorth CarolinaUnited States27705

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: Ashraf S Habib, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03781388
Other Study ID Numbers:
  • Pro00101530
First Posted:
Dec 19, 2018
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 20, 2021