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Prospective Cases for Infections

Phase 4
Waitlist Available
Led By Michelle Palazzo, MD
Research Sponsored by Christine M. Kleinert Institute for Hand and Microsurgery
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 120 minutes post-operation
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

The authors will conduct this study to analyze the effectiveness of peri-operative intercostal nerve blocks (ICNBs) in reducing acute postoperative pain after reconstructive breast surgery and mammoplasty and how it affects the length of hospital stay.

Eligible Conditions
  • Infections
  • Length of Stay
  • Postoperative Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes post-operation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes post-operation 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 pain
Secondary study objectives
Length of Hospital Stay

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Prospective CasesExperimental Treatment1 Intervention
These cases will be recruited prospectively, and receive the intercostal nerve block(s) on operated site(s). Peri-operative injections of 30 ml of 0.25% Bupivacaine each, injected over the 4th, 5th, and 6th ribs on the operated site(s).
Group II: Retrospective ControlsActive Control1 Intervention
Controls will be gathered retrospectively from chart reviews where patient did not receive a intercostal nerve blocker bilaterally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Christine M. Kleinert Institute for Hand and MicrosurgeryLead Sponsor
10 Previous Clinical Trials
925 Total Patients Enrolled
Baptist HealthUNKNOWN
Jewish Hospital and St. Mary's HealthcareOTHER
4 Previous Clinical Trials
909 Total Patients Enrolled
~8 spots leftby Nov 2025
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