Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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)

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

134

Study ID:

NCT03084536

Recruitment Status:

Completed

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Washington University School of Medicine
Saint Louis Missouri, 63110, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

134

Study ID:

NCT03084536

Recruitment Status:

Completed

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

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