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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
134
-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.
Washington University School of Medicine
St Louis, Missouri, United States
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.
Time frame: At 1 year
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.
Time frame: At 1 year
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.
Time frame: At 1 year
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.
Time frame: At baseline and 1 year post-surgery
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-As per routine care
-As per routine care
-As per routine care
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.
Time frame: At baseline and 1 year post-surgery