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Local Anesthetic

Bupivacaine for Spinal Anesthesia

Phase 4
Waitlist Available
Led By Ashraf S Habib, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 minutes after intrathecal drug administration
Awards & highlights

Study Summary

This trial is testing how much bupivacaine is needed for a safe and effective spinal block in obese patients having c-sections.

Eligible Conditions
  • Spinal Anesthesia
  • C-Section
  • Obesity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 minutes after intrathecal drug administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 minutes after intrathecal drug administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of successful blocks for induction (success induction)
Percent of successful blocks for operation (success operation)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Subsequent doseExperimental Treatment1 Intervention
Group II: Starting dose of Bupivacaine (9 mg)Experimental Treatment1 Intervention
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,461 Total Patients Enrolled
Ashraf S Habib, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
281 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
ED90 for Hyperbaric Bupivacaine in Super Obese Parturients
2019. "ED90 for Hyperbaric Bupivacaine in Super Obese Parturients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03781388.
~8 spots leftby Apr 2025
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