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Plain Bupivacaine for Infections

Phase 4
Waitlist Available
Led By Brian M Fitzgerald, MD
Research Sponsored by Brooke Army Medical Center
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 thru 72 hours
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Drug Has Already Been Approved
Pivotal Trial

Summary

Randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery.

Eligible Conditions
  • Infections
  • Bupivacaine
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~thru 72 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and thru 72 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-operative Analgesia
Secondary study objectives
Breast
Increased operative time
Length of Stay (LOS)
+5 more

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Plain BupivacaineExperimental Treatment1 Intervention
Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg)
Group II: Liposomal BupivacaineExperimental Treatment1 Intervention
Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded
Group III: Normal SalinePlacebo Group1 Intervention
Subject will receive 20ml of normal saline infiltration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Brooke Army Medical CenterLead Sponsor
128 Previous Clinical Trials
27,088 Total Patients Enrolled
2 Trials studying Infections
3,300 Patients Enrolled for Infections
Brian M Fitzgerald, MDPrincipal InvestigatorBrooke Army Medical Center
~16 spots leftby Nov 2025
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