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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03084536
• Collaborator: (none)
• Enrollment: 134
• Location: 1
• Arms: 2
• Actual Duration (Months): 44.6
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Breast Cancer Female; Cancer of Breast	Drug: Bupivacaine; Drug: Gabapentin; Drug: Celecoxib; Drug: Acetaminophen; Drug: Midazolam; Drug: Fentanyl	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 134 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
• Actual Study Start Date: Jun 7, 2017
• Actual Primary Completion Date: Feb 25, 2021
• Actual Study Completion Date: Feb 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Preoperative PECS blocks 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; -Given after general anesthesia; Other Names: Bupivacaine hydrochloride ; Drug: Gabapentin; As per routine care Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.; Drug: Celecoxib; 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.; Drug: Acetaminophen; -As per routine care; Drug: Midazolam; -As per routine care; Drug: Fentanyl; -As per routine care
Placebo Comparator: Placebo PECS blocks 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; As per routine care Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.; Drug: Celecoxib; 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.; Drug: Acetaminophen; -As per routine care; Drug: Midazolam; -As per routine care; Drug: Fentanyl; -As per routine care

Outcome Measures

Primary Outcome Measures

1. Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year [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.

2. Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year [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.

3. Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year [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.

Secondary Outcome Measures

1. Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure [At baseline and 1 year post-surgery]

   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.

2. Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure [At baseline and 1 year post-surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

• Principal Investigator: Ryan C Guffey, M.D., Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 26, 2019

More Information

Additional Information:

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03084536
• Other Study ID Numbers: 201703053
• First Posted: Mar 21, 2017
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Breast Neoplasms; Pain, Postoperative; Mastodynia; Acetaminophen; Celecoxib; Fentanyl; Midazolam; Gabapentin; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Preoperative PECS Blocks	Placebo PECS Blocks	Not Randomized to an Arm
Arm/Group Description	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	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.	-Participants were removed from the study prior to being randomized into an Arm.
Period Title: Overall Study
STARTED	53	54	27
COMPLETED	53	54	0
NOT COMPLETED	0	0	27

Baseline Characteristics

Arm/Group Title	Preoperative PECS Blocks	Placebo PECS Blocks	Not Randomized to an Arm	Total
Arm/Group Description	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	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.	-Participants were removed from the study prior to being randomized into an Arm.	Total of all reporting groups
Overall Participants	53	54	27	134
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	57.91	62.27	65.46	61.36
Sex: Female, Male (Count of Participants)
Female	53 100%	54 100%	27 100%	134 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	53 100%	54 100%	27 100%	134 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	1 1.9%	1 1.9%	0 0%	2 1.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	9 17%	4 7.4%	6 22.2%	19 14.2%
White	43 81.1%	49 90.7%	20 74.1%	112 83.6%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	1 3.7%	1 0.7%
Region of Enrollment (participants) [Number]
United States	53 100%	54 100%	27 100%	134 100%

Outcome Measures

1. Primary Outcome

Title	Worst Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
Description	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

Outcome Measure Data

Analysis Population Description

Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.

Arm/Group Title	Preoperative PECS Blocks	Placebo PECS Blocks
Arm/Group Description	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	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.
Measure Participants	29	32
Median (Inter-Quartile Range) [score on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative PECS Blocks, Placebo PECS Blocks
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.68
	Comments
	Method	Kruskal-Wallis
	Comments

2. Primary Outcome

Title	Average Pain as Measured by the Brief Pain Inventory (BPI) at 1 Year
Description	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

Outcome Measure Data

Analysis Population Description

Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.

Arm/Group Title	Preoperative PECS Blocks	Placebo PECS Blocks
Arm/Group Description	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	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.
Measure Participants	29	32
Median (Inter-Quartile Range) [score on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative PECS Blocks, Placebo PECS Blocks
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.67
	Comments
	Method	Kruskal-Wallis
	Comments

3. Primary Outcome

Title	Interference as Measured by the Brief Pain Inventory (BPI) at 1 Year
Description	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

Outcome Measure Data

Analysis Population Description

Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.

Arm/Group Title	Preoperative PECS Blocks	Placebo PECS Blocks
Arm/Group Description	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	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.
Measure Participants	28	32
Median (Inter-Quartile Range) [score on a scale]	0	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative PECS Blocks, Placebo PECS Blocks
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	Kruskal-Wallis
	Comments

4. Secondary Outcome

Title	Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Physical Health Summary Measure
Description	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

Outcome Measure Data

Analysis Population Description

Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.

Arm/Group Title	Preoperative PECS Blocks	Placebo PECS Blocks
Arm/Group Description	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	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.
Measure Participants	11	15
Median (Inter-Quartile Range) [score on a scale]	-3.1	-0.8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative PECS Blocks, Placebo PECS Blocks
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.44
	Comments
	Method	Kruskal-Wallis
	Comments

5. Secondary Outcome

Title	Change in Quality of Life as Measured by the Veterans RAND12 Questionnaire Mental Health Summary Measure
Description	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

Outcome Measure Data

Analysis Population Description

Due to missing 1 year follow-up Brief Pain Inventories, all enrolled participants were not evaluable or included in this outcome measure.

Arm/Group Title	Preoperative PECS Blocks	Placebo PECS Blocks
Arm/Group Description	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	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.
Measure Participants	11	15
Median (Inter-Quartile Range) [score on a scale]	0	1.9

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Preoperative PECS Blocks, Placebo PECS Blocks
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.88
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Time Frame	-Adverse events will be tracked for 2 weeks after nerve block administration or patient discharge, whichever is later, up to 3 weeks. Most patients will be discharged within 24 hours. Adverse events thought to be at least possibly related to surgery will not be collected. -All-cause mortality was collected from day of surgery through completion of follow-up, up to 1 year. The one mortality occurred during follow-up and attribution to the PECS block was deemed as unrelated.
Adverse Event Reporting Description	Participants in the Not Randomized Arm were not assess for Serious and Other Adverse Events as they did not receive any study treatment or placebo.
Arm/Group Title	Preoperative PECS Blocks		Placebo PECS Blocks		Not Randomized to an Arm
Arm/Group Description	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		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.		-Participants were removed from the study prior to being randomized into an Arm and did not receive any treatment on the study.
All Cause Mortality
	Preoperative PECS Blocks		Placebo PECS Blocks		Not Randomized to an Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/53 (1.9%)		0/54 (0%)		1/27 (3.7%)
Serious Adverse Events
	Preoperative PECS Blocks		Placebo PECS Blocks		Not Randomized to an Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/53 (0%)		0/54 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Preoperative PECS Blocks		Placebo PECS Blocks		Not Randomized to an Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/53 (9.4%)		0/54 (0%)		0/0 (NaN)
General disorders
Swelling	1/53 (1.9%)		0/54 (0%)		0/0 (NaN)
Injury, poisoning and procedural complications
Seroma	2/53 (3.8%)		0/54 (0%)		0/0 (NaN)
Vascular disorders
Hematoma	2/53 (3.8%)		0/54 (0%)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.