Breast Cancer Clinical Trial
Official title:
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
Verified date | March 2022 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 134 |
Est. completion date | February 25, 2021 |
Est. primary completion date | February 25, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year | The participant is asked to rate their pain by circling the one number that best describes their pain at its worst in the past week.
0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain. |
At 1 year | |
Primary | Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year | The participant is asked to rate their pain by circling the one number that best describes their pain on the average.
0=no pain and 10 = pain as bad as they can imagine. The higher number indicates worse pain. |
At 1 year | |
Primary | Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year | The participant is asked circle the one number that describes how much, during the past week pain has interfered with general activity, mood, walking ability, normal work (includes both work outside the home and housework), relations with other people, sleep, and enjoyment of life.
0=does not interference and 10 = completely interferes. The higher number indicates more interference from pain. The scores for each subsection will be averaged. |
At 1 year | |
Secondary | Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure | The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
The higher the score the better quality of life. Scores are standardized to a mean of 50 with a range of -0.809-70.71. |
At baseline and 1 year post-surgery | |
Secondary | Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure | The 12 items in the questionnaire correspond to eight principal physical and mental health domains including general health perceptions; physical functioning; role limitations due to physical and emotional problems; bodily pain; energy-fatigue, social functioning and mental health. The 12 items are summarized into two scores, a Physical Health Summary Measure (PCS) and a Mental Health Summary Measure (MCS).
The higher the score the better quality of life. Scores are standardized to a mean of 50 with a range of -1.465-77.09. |
At baseline and 1 year post-surgery |
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