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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

Study 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 minutes (starting from placement of labor neuraxial block) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fetal heart rate

Secondary outcome measures

Blood pressure

Dermatomal level

Maternal Pain level: visual analogue scale

+2 more

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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Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor

211 Previous Clinical Trials

84,510 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

Media Library

Epidural fentanyl/spinal bupivacaine (Opioid Analgesic) Clinical Trial Eligibility Overview. Trial Name: NCT03623256 — Phase 4

Labor Pain Research Study Groups: Spinal Bupivacaine, Spinal Fentanyl, Spinal Fentanyl and Bupivacaine, Epidural fentanyl /spinal bupivacaine

Labor Pain Clinical Trial 2023: Epidural fentanyl/spinal bupivacaine Highlights & Side Effects. Trial Name: NCT03623256 — Phase 4

Epidural fentanyl/spinal bupivacaine (Opioid Analgesic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03623256 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has there been any past research conducted utilizing Epidural fentanyl and spinal bupivacaine?

"Presently, 141 clinical trials are in progress evaluating Epidural fentanyl /spinal bupivacaine with 26 studies taking place at Phase 3. Primarily conducted near Germantown, Tennessee, these investigations into Epidural fentanyl /spinal bupivacaine have spread to 204 distinct sites across the globe."

Answered by AI

What medical conditions have been addressed with Epidural fentanyl /spinal bupivacaine?

"Epidural fentanyl/spinal bupivacaine is commonly administered to treat pemphigus, in addition to acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

Is the research team actively recruiting participants for this experiment?

"This clinical trial is currently recruiting participants, as per information provided on the website of clinicaltrials.gov. The study was first released on October 28th 2019 and has undergone its most recent update July 21st 2021."

Answered by AI

How many participants are accepted for the current clinical trial?

"Affirmative. Clinicaltrials.gov denotes that the study, initially unveiled on October 28th 2019, requires 558 subjects from 1 clinical trial centre and is actively recruiting participants."

Answered by AI

Is the blend of epidural fentanyl and spinal bupivacaine sanctioned by the Food & Drug Administration?

"The safety of epidural fentanyl and spinal bupivacaine is rated highly, receiving a score of 3. This treatment being in Phase 4 signifies that it has been approved by the relevant authorities after multiple rounds of data collection and analysis."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia

Efrain Riveros Perez, MD 2019. "Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03623256.

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