Back to resultsPECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
Primary Purpose
Breast Cancer, Breast Cancer Female, Cancer of Breast
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine
Gabapentin
Celecoxib
Acetaminophen
Midazolam
Fentanyl
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
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)
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Preoperative PECS blocks
Placebo PECS blocks
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03084536
First Posted
March 8, 2017
Last Updated
March 3, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03084536
Brief Title
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
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 7, 2017 (Actual)
Primary Completion Date
February 25, 2021 (Actual)
Study Completion Date
February 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Breast Cancer Female, Cancer of Breast
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Preoperative PECS blocks
Arm Type
Active Comparator
Arm 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
Arm Title
Placebo PECS blocks
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Other Intervention Name(s)
Bupivacaine hydrochloride
Intervention Description
-Given after general anesthesia
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
As per routine care
Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
Intervention Type
Drug
Intervention Name(s)
Celecoxib
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
-As per routine care
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
-As per routine care
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Intervention Description
-As per routine care
Primary Outcome Measure Information:
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
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
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
Secondary Outcome Measure Information:
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
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan C Guffey, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
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