← Back to Search

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

All Individual Drugs Already Approved

Approved for 10 Other Conditions

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

Breast Cancer
Mastectomy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postop pain and satisfaction scores

The Number of adverse events

Secondary study objectives

Overall narcotic use

Time from recovery to discharge

Time in recovery

Awards & Highlights

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

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

Do I qualify?Apply below to find out