PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

• Status: Completed
• Trial end date: 2021-02-25
• Target enrollment: 0
• Participant gender: Female

Summary

In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Treatments: Acetaminophen; Bupivacaine; Celecoxib; Fentanyl; Gabapentin; Midazolam

Criteria

Inclusion Criteria:

• Scheduled to undergo elective breast cancer surgeries at Barnes-Jewish Hospital:

• unilateral axillary dissection

• unilateral modified radical mastectomy

• mastectomy with same day unilateral reconstruction

• unilateral sentinel lymph node biopsy (SLNB)

• partial mastectomy with unilateral SLNB

• simple mastectomy with unilateral SLNB

• At least 18 years of age.

• Able to understand and willing to sign an Institutional Review Board (IRB)-approved written informed consent document.

• Enrollment in the SATISFY-SOS study (WUSTL IRB# 201203088, NCT02032030).

Exclusion Criteria:

• Planned for bilateral axillary or bilateral reconstruction surgery.

• Previous surgery on the surgical breast and/or axilla with the exception of partial mastectomy or sentinel lymph node biopsy

• Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.

• Current or past medical history of liver disease or cirrhosis with an elevated INR >1.4 or currently elevated transaminase levels.

• Known contraindications to peripheral nerve block placement.

• Pregnant or breastfeeding.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition

• Planned additional surgery to the surgical breast or axilla in the next year (exception would be minor surgery to breast but not axilla such as simple tissue expander replacement or lumpectomy)