The Use of Pecs Blocks in Combination With Exparel in Breast Reconstruction Surgery

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This project intends to more thoroughly investigate the direct influence of Pecs blocks in the administration of Exparel, a non-opioid analgesic, in breast reconstruction surgery. The hypothesis is that this analgesic delivery method will significantly reduce negative outcomes such as post-operative pain, opioid use, and nausea while increasing positive outcomes such as post-operative physical activity.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwestern University
• Collaborator: Pacira Pharmaceuticals, Inc
• Treatments: Bupivacaine; Lidocaine

Criteria

Inclusion Criteria:

1. Subjects greater than 18 years of age.

2. Subject who are undergoing implant-based, tissue expander breast reconstruction surgery.

Exclusion Criteria:

1. Subjects undergoing flap breast reconstruction.

2. Subjects who are undergoing direct-to-implant surgery.

3. Subjects who have previously undergone radiation therapy.

4. Medical or psychiatric condition that may increase the risk associated with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.

5. Subjects who are pregnant at the date of surgery.