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Local Anesthetic

Part B Group 4 for Pregnancy

Phase 4
Waitlist Available
Led By Brendan Carvalho, MBBCh, MDCH
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ASA I & II, Nulliparous and Multiparous, Spontaneous/Induced/Augmented Labor, Early active labor (cervix <5 cm (if known)), Pain (VPS) > 3, 18-45 years of age
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from initial epidural bolus to approximately 6-12 hours following delivery
Awards & highlights

Study Summary

This study is evaluating whether a new method of administering pain medication may be more effective than current methods.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from initial epidural bolus to delivery (up to approximately 16 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from initial epidural bolus to delivery (up to approximately 16 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Minimum Local Analgesic Concentration (MLAC) of the Final Participants in Each Respective Group at Study Completion
Secondary outcome measures
Labor Outcome (Spontaneous, Assisted, Cesarean)
Number of Participants Requiring Treatment for Pruritus, Nausea and Vomiting, or Hypotension
Number of Participants With Maternal Nausea/Vomiting
+4 more
Other outcome measures
Duration of Epidural Analgesia
Maternal Pruritis
Motor Weakness
+3 more

Trial Design

4Treatment groups
Active Control
Group I: Part B Group 4Active Control2 Interventions
PIEB bupivacaine and CEI sufentanil
Group II: Part B Group 3Active Control2 Interventions
CEI bupivacaine and PIEB sufentanil
Group III: Part A Group 1Active Control2 Interventions
CEI bupivacaine and CEI sufentanil
Group IV: Part A Group 2Active Control2 Interventions
PIEB bupivacaine and PIEB sufentanil

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,383 Previous Clinical Trials
17,333,874 Total Patients Enrolled
Manchester University NHS Foundation TrustOTHER_GOV
203 Previous Clinical Trials
118,339 Total Patients Enrolled
Brendan Carvalho, MBBCh, MDCHPrincipal Investigator - Stanford University
Stanford University
1 Previous Clinical Trials
160 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
Anesthesia & AnalgesiaJournal
Intermittent Epidural Bolus Compared with Continuous Epidural Infusions for Labor Analgesia
George, Ronald B., Terrence K. Allen, and Ashraf S. Habib. 2013. “Intermittent Epidural Bolus Compared with Continuous Epidural Infusions for Labor Analgesia”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e3182713b26.
Anesthesia & AnalgesiaJournal
Intermittent Epidural Bolus Compared with Continuous Epidural Infusions for Labor Analgesia
George, Ronald B., Terrence K. Allen, and Ashraf S. Habib. 2013. “Intermittent Epidural Bolus Compared with Continuous Epidural Infusions for Labor Analgesia”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e3182713b26.
clinicaltrials.govStudy
PIEB vs CEI for Labor Analgesia: An MLAC Study
Brendan Carvalho 2015. "PIEB vs CEI for Labor Analgesia: An MLAC Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02573597.
~3 spots leftby Apr 2025
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