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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer, Breast Cancer Female, Cancer of Breast

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Gabapentin
* Drug: Celecoxib
* Drug: Acetaminophen
* Drug: Midazolam
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Preoperative PECS blocks<br>PECS I & II block will be administered preoperatively For unilateral surgeries, a PECS I block will be performed with 0.15mL/kg of 0.375% bupivacaine (maximum 10mL). The PECS II block will be performed with 0.3 mL/kg of the same solution (maximum 20mL). If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side with 0.2mL/kg of 0.375% bupivacaine (maximum 20mL) To ensure blind integrity, study drug syringes will be marked only study drug and subject number Perioperative analgesic will be encouraged.. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative area. All patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist | Drug: Bupivacaine<br>* -Given after general anesthesia<br>* Other names: Bupivacaine hydrochloride;Drug: Gabapentin<br>* As per routine care Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.<br>Drug: Celecoxib<br>* 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.<br>Drug: Acetaminophen<br>* -As per routine care<br>Drug: Midazolam<br>* -As per routine care<br>Drug: Fentanyl<br>* -As per routine care<br>|
| Placebo Comparator: Placebo PECS blocks<br>A sham block (normal saline) will be placed preoperatively To ensure blind integrity, study drug syringes will be marked only study drug and subject number. Perioperative analgesic regimen will be encouraged. Gabapentin 300mg, celecoxib 200mg and acetaminophen 1000mg will be administered to all patients following arrival to the preoperative holding area. On the day of surgery all patients will receive premedication of 1-2 mg midazolam IV (age < 65) and 50-100 μg fentanyl IV prior to the block placement or entry to the operating room at the discretion of the regional team or operating room anesthesiologist. | Drug: Gabapentin<br>* As per routine care Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.<br>Drug: Celecoxib<br>* 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.<br>Drug: Acetaminophen<br>* -As per routine care<br>Drug: Midazolam<br>* -As per routine care<br>Drug: Fentanyl<br>* -As per routine care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |