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Local Anesthetic

Ropivacaine and Bupivacaine for Labor Pain

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 from placement of epidural to delivery, up to 32 hours
Awards & highlights

Study Summary

This trial is comparing two ways of numbing pain during labor, to see if one is better than the other.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from placement of epidural to delivery, up to 32 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and from placement of epidural to delivery, up to 32 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
Block quality as defined by a composite of five components
Secondary outcome measures
Duration of the second stage of labor
Incidence of motor block
Maternal adverse events
+5 more

Trial Design

2Treatment groups
Active Control
Group I: Dural Puncture EpiduralActive Control1 Intervention
A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.
Group II: Combined Spinal EpiduralActive Control2 Interventions
10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,969 Total Patients Enrolled
2 Trials studying Labor Pain
320 Patients Enrolled for Labor Pain
Ashraf S Habib, MDPrincipal InvestigatorDuke University Hospital
4 Previous Clinical Trials
226 Total Patients Enrolled

Media Library

Bupivacaine 0.25% Injectable Solution (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05068661 — Phase 4
Labor Pain Research Study Groups: Dural Puncture Epidural, Combined Spinal Epidural
Labor Pain Clinical Trial 2023: Bupivacaine 0.25% Injectable Solution Highlights & Side Effects. Trial Name: NCT05068661 — Phase 4
Bupivacaine 0.25% Injectable Solution (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05068661 — Phase 4

Frequently Asked Questions

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

What health issues can Dural Puncture Epidural offer relief for?

"Dural Puncture Epidural can be applied to remedy conditions such as permphigus, acute nonspecific tenosynovitis, and anesthesia-related issues."

Answered by AI

Does the inclusion criteria for this medical research project extend to octogenarians?

"The research protocol for this medical trial necessitates that potential participants are aged 18 to 45 years old. Conversely, there are 31 studies suitable for minors and 170 studies dedicated to seniors."

Answered by AI

Are there any additional reports concerning the outcomes of Dural Puncture Epidural trials?

"Presently, 197 active clinical trials are being conducted for Dural Puncture Epidural with 38 of these studies in the Phase 3 stage. These experiments span 279 various locations around the world; Germantown, Tennessee is a notable centre that hosts numerous research projects regarding this subject matter."

Answered by AI

How many individuals are participating in this research endeavor?

"Affirmative. Clinicaltrials.gov lists this medical trial as actively seeking participants, with 100 patients needed from a single centre since its initial posting on November 21st 2021 and last update of January 14th 2022."

Answered by AI

Does the FDA endorse Dural Puncture Epidural as an approved method of treatment?

"Due to the fact that Dural Puncture Epidural has already been approved, our team at Power rated its safety with a score of 3."

Answered by AI

Is it possible for me to take part in this experiment?

"In order to be eligible for this clinical trial, patients must suffer from labor pains and fall between 18-45 years of age. At the moment, 100 potential candidates are being recruited."

Answered by AI

Is enrollment in this clinical research still available for participants?

"According to clinicaltrials.gov the medical trial is actively enlisting volunteers, having first been posted on November 21st 2021 and amended most recently on January 14th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Comparing Effectiveness of CSE Versus DPE for Labor Analgesia
2021. "Comparing Effectiveness of CSE Versus DPE for Labor Analgesia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05068661.
~29 spots leftby Apr 2025
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