PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
Condition: Breast Cancer; Breast Cancer Female; Cancer of Breast
MeSH terms: Breast Neoplasms; Pain, Postoperative; Mastodynia
Intervention: Bupivacaine; Gabapentin; Celecoxib; Acetaminophen; Midazolam; Fentanyl
Intervention description: -Given after general anesthesia; As per routine care
Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.; As per routine care
Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
Naproxen will be substituted for celecoxib in patients with sulfa allergies.; -As per routine care; -As per routine care; -As per routine care
Intervention MeSH terms: Acetaminophen; Celecoxib; Midazolam; Fentanyl; Gabapentin; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 134.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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.
    

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)