Clinical trial NCT03084536: PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
Official title: PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Breast Cancer Female
Cancer of Breast
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 134
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Primary outcomes:
measure: Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
timeFrame: At 1 year
measure: Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
timeFrame: At 1 year
measure: Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year
timeFrame: At 1 year
Secondary outcomes:
measure: Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure
timeFrame: At baseline and 1 year post-surgery
measure: Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure
timeFrame: At baseline and 1 year post-surgery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Ryan C Guffey, M.D.
role: PRINCIPAL_INVESTIGATOR
References: