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Local Anesthetic

Liposomal bupivacaine for Mastectomy

Phase 2
Waitlist Available
Led By Eleni Tousimis, MD
Research Sponsored by Georgetown University
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 1 week
Awards & highlights

Study Summary

This trial is testing whether liposomal bupivacaine is more effective than standard bupivacaine or no local anesthetic in reducing postoperative pain after breast surgery. Patients will be randomly assigned to one of three groups: injection of liposomal bupivacaine, injection of standard bupivacaine, or no injection of local anesthetic. All patients will be able to receive IV and oral narcotic medications in the postoperative period on an as-needed basis.

Eligible Conditions
  • Mastectomy
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postop pain and satisfaction scores
The Number of adverse events
Secondary outcome measures
Overall narcotic use
Time from recovery to discharge
Time in recovery

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Liposomal bupivacaineExperimental Treatment1 Intervention
If a patient is randomized to the LB arm, at the appropriate time, under a surgeon's direction, 266 mg of (liposomal bupivacaine) LB in 20 cc of solution was expanded with various amounts of normal saline to cover the appropriate surgical field. Our routine expansion for a bilateral mastectomy is to add 80 mL of saline to 20 mL (266 mg) of LB. In our practice,we use an 18-gauge needle to inject the medication in a "field-effect" encompassing all 4 quadrants of the chest muscles (pectoralis and serratus) followed by injecting around the edges of the skin incision and drain site. This occurs prior to dissection of the pectoralis muscle and implant or tissue expander placement.
Group II: Standard bupivacaineActive Control1 Intervention
Patients randomized to the SB arm will receive weight-based dosing of bupivacaine, administered in the same manner as the LB arm.
Group III: PlaceboPlacebo Group1 Intervention
Patients who are in the placebo arm will have a similar volume of saline injected into the operative site.
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?

Georgetown UniversityLead Sponsor
343 Previous Clinical Trials
136,402 Total Patients Enrolled
1 Trials studying Mastectomy
261 Patients Enrolled for Mastectomy
Eleni Tousimis, MDPrincipal InvestigatorMedStar Georgetown University Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo
2019. "Post-Mastectomy Analgesia Using Exparel (Liposomal) Versus Standard Bupivacaine or Placebo". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03504865.
All > Exparel
~17 spots leftby Apr 2025
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