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Bupivacaine for Local Anesthesia
Phase 2
Waitlist Available
Led By Nisha Lakhi, MD
Research Sponsored by Richmond University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All scheduled Cesarean deliveries with intrathecal or epidural anesthesia
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This study will investigate the effect of three types of wound infiltration on post Cesarean opioid analgesia consumption when used in conjunction with an opioid free postoperative analgesia pathway.
Eligible Conditions
- Local Anesthesia
- Opioid Use Disorder
- Postoperative Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total number of opioid free Cesarean deliveries
Secondary outcome measures
Breast feeding capacity
Complications from procedures
Postoperative hospital stay
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Bupivacaine and DexmedetomidineExperimental Treatment2 Interventions
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine and 1.5 mcg/kg of dexmedetomidine will be diluted with normal saline to make 25 mL of solution .
Group II: BupivacaineExperimental Treatment1 Intervention
Wound Infiltration with 20 mL (150mg) of 0.75% bupivacaine diluted with 5 mL of normal saline to give a 25 mL
Group III: PlaceboPlacebo Group1 Intervention
Wound infiltration with a placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Dexmedetomidine
FDA approved
Find a Location
Who is running the clinical trial?
Richmond University Medical CenterLead Sponsor
4 Previous Clinical Trials
1,382 Total Patients Enrolled
Nisha Lakhi, MDPrincipal InvestigatorRichmond University Medical Center
2 Previous Clinical Trials
1,282 Total Patients Enrolled
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