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Local Anesthetic

2 ml Bupivacaine for Low Blood Pressure (ET-50-Fent Trial)

Phase 2
Waitlist Available
Led By Albert Moore, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients 18 years or older, presenting for scheduled cesarean delivery to the C7 birthing centre.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one hour
Awards & highlights

ET-50-Fent Trial Summary

Hypotension is extremely common after induction of spinal anesthesia for cesarean delivery. Anesthetic blockade of the sympathetic outflow of the spinal cord causes vasodilation, and is one cause of this hypotension. The higher the spread of the blockade will result in a higher incidence of hypotension. Injected hyperbaric medication has about 15 minutes to spread within the intrathecal space before it will be taken up by the nerve roots. The time that a patient remains in one position after medication injection will affect the spread of the resultant anesthetic block. A patient who is left sitting for a longer period of time after injection of hyperbaric medication will have a lower level of block than someone who is placed supine immediately. In this study, the investigators wish to use up down sequential analysis to determine the time period a patient should remain seated after intrathecal injection of hyperbaric bupivacaine and fentanyl that will result in a 50% rate of hypotension.

Eligible Conditions
  • Low Blood Pressure
  • Pregnancy

ET-50-Fent Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

ET-50-Fent Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sitting time to avoid hypotension
Secondary outcome measures
Pain occurence

ET-50-Fent Trial Design

2Treatment groups
Active Control
Group I: 2 ml BupivacaineActive Control1 Intervention
2 ml Bupivacaine with 15 micrograms of fentanyl
Group II: 1.5 ml BupivacaineActive Control1 Intervention
1.5 ml Bupivacaine with 15 micrograms of fentanyl

Find a Location

Who is running the clinical trial?

McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
442 Previous Clinical Trials
159,134 Total Patients Enrolled
Albert Moore, MDPrincipal InvestigatorMcGill
4 Previous Clinical Trials
280 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~3 spots leftby Apr 2025