Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)

[
  {
    "op": "replace",
    "path": "/protocolSection/identificationModule/briefTitle",
    "value": "Paravertebral Block (PVC) Versus Pectoral Nerve Block (PEC)"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/statusVerifiedDate",
    "value": "2022-12"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/overallStatus",
    "value": "TERMINATED"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/startDateStruct/date",
    "value": "2017-03-09"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
    "value": "2019-05-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/primaryCompletionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/date",
    "value": "2019-05-21"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/completionDateStruct/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2023-01-04"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2023-01-06"
  },
  {
    "op": "add",
    "path": "/protocolSection/statusModule/whyStopped",
    "value": "Standards of care changed at the institution so that PEC procedures were no longer common or preferred as a method of pain control for breast surgery."
  },
  {
    "op": "replace",
    "path": "/protocolSection/descriptionModule/briefSummary",
    "value": "The purpose of this study is to compare two standard methods of pain control management used at Spectrum Health for patients undergoing breast surgery.\nThe two methods being compared are the paravertebral block (PVB) and the pectoral nerve block (PEC).\nPostoperative pain control is essential following any major operative procedure.\nA variety of methods have been used to ensure adequate pain control, each with its own advantages and risks.\nIncreasingly, attention has focused on regional methods of analgesia, which may allow for reduction in systemic narcotic use and their associated complications.\nProposed benefits of regional analgesia and a resultant reduction in narcotic use include decreased risk of cancer progression, decreased length of stay, and decreased risk of ileus."
  },
  {
    "op": "replace",
    "path": "/protocolSection/conditionsModule/keywords/2",
    "value": "Pectoral Nerve Block"
  },
  {
    "op": "add",
    "path": "/protocolSection/designModule/designInfo/interventionModelDescription",
    "value": "Participants are randomized to one of two interventional arms (paravertebral block versus pectoral nerve block)."
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/count",
    "value": 102
  },
  {
    "op": "replace",
    "path": "/protocolSection/designModule/enrollmentInfo/type",
    "value": "ACTUAL"
  },
  {
    "op": "replace",
    "path": "/protocolSection/outcomesModule/secondaryOutcomes/0/measure",
    "value": "Pain control measured by length of operation"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ul><li>Female patients ≥ 18 years of age</li><li>Total mastectomy or partial mastectomy with or without reconstruction OR planned lumpectomy.</li><li>Patient determined by their surgeon as medically able to receive a regional block for post-operative analgesia</li><li>Patient agrees to participate in the study and signs informed consent</li></ul><p>Exclusion Criteria:</p><ul><li>Neoadjuvant radiation therapy</li><li>Stage IV cancer</li><li>Previous breast surgery (excluding percutaneous biopsies of all types)</li><li>History of either PVB or PEC procedures</li><li>Planned general anesthesia use during surgery</li><li>Allergies to ropivacaine, midazolam, fentanyl, or propofol</li><li>Pregnant women</li><li>Prisoners</li><li>Adults unable to consent</li><li>Non-English-speaking patients</li></ul>"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/status"
  },
  {
    "op": "remove",
    "path": "/protocolSection/contactsLocationsModule/locations/0/contacts"
  }
]