PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery
NCT ID: NCT03084536
Last Updated: 2024-12-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
134 participants
INTERVENTIONAL
2017-06-07
2021-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Bupivacaine
-Given after general anesthesia
Gabapentin
* As per routine care
* Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
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.
Acetaminophen
-As per routine care
Midazolam
-As per routine care
Fentanyl
-As per routine care
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.
Gabapentin
* As per routine care
* Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
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.
Acetaminophen
-As per routine care
Midazolam
-As per routine care
Fentanyl
-As per routine care
Interventions
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Bupivacaine
-Given after general anesthesia
Gabapentin
* As per routine care
* Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
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.
Acetaminophen
-As per routine care
Midazolam
-As per routine care
Fentanyl
-As per routine care
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Ryan C Guffey, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201703053
Identifier Type: -
Identifier Source: org_study_id