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Opioid Analgesic
Epidural fentanyl /spinal bupivacaine for Labor Pain
Phase 4
Waitlist Available
Led By Efrain Riveros Perez, MD
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minutes (starting from placement of labor neuraxial block)
Awards & highlights
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Drug Has Already Been Approved
Summary
This trial will compare the effect of epidural fentanyl vs. intrathecal fentanyl on the rate of fetal bradycardia in parturients during labor.
Eligible Conditions
- Labor Pain
- Obstetric Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minutes (starting from placement of labor neuraxial block)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minutes (starting from placement of labor neuraxial block)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fetal heart rate
Secondary study objectives
Blood pressure
Dermatomal level
Maternal Pain level: visual analogue scale
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Epidural fentanyl /spinal bupivacaineExperimental Treatment1 Intervention
Spinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL).
Group II: Spinal BupivacaineActive Control1 Intervention
Spinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL)
Group III: Spinal FentanylActive Control1 Intervention
Spinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL)
Group IV: Spinal Fentanyl and BupivacaineActive Control1 Intervention
Spinal combination of preservative-free 0.25% bupivacaine (0.5 mL) and fentanyl 25 mcg (0.5 mL). (Total Volume 1 mL).
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Who is running the clinical trial?
Augusta UniversityLead Sponsor
215 Previous Clinical Trials
85,132 Total Patients Enrolled
1 Trials studying Labor Pain
35 Patients Enrolled for Labor Pain
Efrain Riveros Perez, MDPrincipal Investigator - Augusta University
AU Medical Center, PPG Alternative Collections LLC
3 Previous Clinical Trials
906 Total Patients Enrolled
1 Trials studying Labor Pain
35 Patients Enrolled for Labor Pain
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Eligibility Criteria:
This trial includes the following eligibility criteria:- The mother has a high body temperature.You are allergic to certain numbing medications or fentanyl.You are experiencing rapid uterine contractions before receiving pain relief medication in your spine.You do not want to take part in the study.You are full-term in your pregnancy, meaning you have reached 37 weeks or more.A specific anesthesia method called "combined spinal-epidural" will not be used.You cannot have a specific type of anesthesia called neuraxial technique.You are experiencing itching before receiving a certain type of pain relief.You are not currently experiencing any pregnancy-related health problems.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal Bupivacaine
- Group 2: Spinal Fentanyl
- Group 3: Spinal Fentanyl and Bupivacaine
- Group 4: Epidural fentanyl /spinal bupivacaine
Awards:
This trial has 5 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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