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Local Anesthetic
Local Anesthesia for Vaginal Lacerations
Phase 4
Recruiting
Led By Fatima Estrada, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Ongoing functioning epidural throughout the laceration repair
>= 18 years old
Must not have
Women who underwent an operative vaginal delivery and whose vaginal delivery was complicated by a postpartum hemorrhage
Complaints of non-functional epidural
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 hours after perineal laceration
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to compare the use of local anesthesia during perineal laceration repair for women who already have epidural analgesia. The study hypothesizes that adding a locally injected anal
Who is the study for?
This trial is for healthy women over 18 who've had a single baby delivered vaginally, resulting in a second-degree perineal tear. They must speak English or Spanish and be able to consent for themselves. It's not specified who can't join.
What is being tested?
The study tests if injecting bupivacaine with epinephrine reduces pain better than a fake (saline) injection after epidural anesthesia wears off post-vaginal delivery. Women are randomly assigned to either the real drug or sham treatment without knowing which one they receive.
What are the potential side effects?
Possible side effects of bupivacaine with epinephrine may include temporary numbness beyond the target area, increased heart rate, nervousness, restlessness, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My epidural is working during my laceration repair.
Select...
I am 18 years old or older.
Select...
I can make my own medical decisions.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a vaginal delivery with surgery and experienced heavy bleeding afterward.
Select...
I am experiencing issues with my epidural.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately and 24 hours after perineal laceration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately and 24 hours after perineal laceration
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maternal Satisfaction
Pain score after injection at perineal laceration
Time to first analgesic
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Local Anesthesia armExperimental Treatment2 Interventions
Bupivicaine and Epinephrine
Group II: Normal saline sham armPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
2013
Completed Phase 4
~1530
Epinephrine
2014
Completed Phase 4
~3890
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
458 Previous Clinical Trials
588,514 Total Patients Enrolled
Fatima Estrada, MDPrincipal InvestigatorMontefiore Medical Center