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

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ClinicalTrials.gov Identifier: NCT03084536
Recruitment Status : Recruiting
First Posted : March 21, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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 : June 7, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Bupivacaine

Arm Intervention/treatment
Active Comparator: Preoperative PECS blocks
  • PECS I & II block will be administered preoperatively
  • For unilateral surgeries, PECS I block will be performed bupivacaine. The PECS II block will be performed with the same solution. If there is a contralateral surgery (simple mastectomy) a PECS II block will also be performed on the other side.
  • To ensure blind integrity, study drug syringes will be marked only "study drug" and subject number
  • Perioperative analgesic will be standardized. 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 Name: 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 standardized for research subjects. 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




Primary Outcome Measures :
  1. Change in persistent postoperative pain compared with multimodal analgesia as measured by the Brief Pain Inventory (BPI) [ Time Frame: Up to 12 months post surgery ]
    • BPI scores will be compared between groups by Mann Whitney U and adjusted for known confounders and baseline pain by rank ANCOVA regression.
    • Administered baseline, 2 weeks post-op, 6 months post-op, and 12 months post-op
    • Modified BPI baseline: 10 questions regarding current pain felt, medications taken for pain, pain relief, and how pain has affected daily living
    • Follow-up BPI: 12 questions regarding current pain felt, medications taken for pain, pain relief, and how pain has affected daily living


Secondary Outcome Measures :
  1. Postoperative quality of life as measured by the Veterans RAND12 questionnaire [ Time Frame: 12 months post surgery ]
    • Change in the 1 year VR12 score from baseline results will be compared between study groups by Mann Whitney U and adjusted for known confounders using ANCOVA regression analysis.
    • 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 and a "Mental Health Summary Measure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo elective breast cancer surgery involving the axilla or mastectomy with same day reconstruction at Barnes-Jewish Hospital.
  • 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 surgery.
  • Previous surgery other than lumpectomy or sentinel lymph node biopsy on the surgical breast or axilla.
  • Pre-existing pain in the axilla affecting the ability to use extremity for activities of daily living or requiring medication for treatment.
  • Pre-existing liver disease: elevated INR >1.4 or elevated transaminase levels, or patient medical history of cirrhosis, or liver disease.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084536


Contacts
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Contact: Ryan C Guffey, M.D. (314) 286-2883 rguffey@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ryan C Guffey, M.D.    314-286-2883    rguffey@wustl.edu   
Principal Investigator: Ryan C Guffey, M.D.         
Sub-Investigator: Mitchell E Fingerman, M.D.         
Sub-Investigator: Erin Gibbons, M.D.         
Sub-Investigator: Susan Ironstone, M.D.         
Sub-Investigator: Arbi Ben Abdallah         
Sub-Investigator: Rebecca L Aft, M.D.         
Sub-Investigator: Amy E Cyr, M.D.         
Sub-Investigator: Julie A Margenthaler, M.D.         
Sub-Investigator: Simon Haroutounian, Ph.D., MSC         
Sub-Investigator: Michael S Avidan, MBBCH         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ryan C Guffey, M.D. Washington University School of Medicine

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03084536     History of Changes
Other Study ID Numbers: 201703053
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Breast Neoplasms
Pain, Postoperative
Mastodynia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Fentanyl
Midazolam
Gabapentin
Acetaminophen
Celecoxib
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General