{
"info": {
"nct_id": "NCT02838173",
"official_title": "Serratus Plane Block for the Prevention of Chronic Pain After Breast Cancer Surgery",
"inclusion_criteria": "* Women scheduled for elective breast neoplasm surgery\n* Of ASA classification 1, 2 or 3\n* Patients who provide written informed consent\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Minor patients\n* Patients refusing to sign the consent\n* Patients included in another protocol within 3 months\n* Pregnant or lactating patients\n* Patients with history of allergy to local anesthetics (Ropivacaine)\n* Patients with contraindication to regional anesthesia (coagulopathy, local infection ...)\n* Patients with history of prior breast surgery (excluding diagnostic biopsy)\n* Patients with history of chronic pain\n* Patients with a history of psychiatric disorder",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
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"criterions": [
{
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"criterion": "gender",
"requirement": {
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"expected_value": "female"
}
},
{
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"criterion": "surgery type",
"requirement": {
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"expected_value": "elective breast neoplasm surgery"
}
}
]
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"logical_structure": {
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"requirement": {
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{
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"requirement": {
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}
}
]
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "ASA classification",
"requirement": {
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"expected_value": [
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"2",
"3"
]
}
}
]
},
"logical_structure": {
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"criterion": "ASA classification",
"requirement": {
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"expected_value": [
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"2",
"3"
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},
{
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"criterion": "informed consent",
"requirement": {
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"expected_value": true
}
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"logical_structure": {
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"requirement": {
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"expected_value": true
}
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]
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{
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"expected_value": "healthy"
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}
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}
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{
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{
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"criterion": "gender",
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}
}
]
},
"logical_structure": {
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"criterion": "gender",
"requirement": {
"requirement_type": "expected_value",
"expected_value": "female"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
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},
"logical_structure": {
"and_criteria": [
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"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
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"expected_value": {
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"value": 18,
"unit": "Years"
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],
"exclusion_lines": [
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"criterions": [
{
"exact_snippets": "Minor patients",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
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"operator": "<",
"value": 18,
"unit": "years"
}
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"logical_structure": {
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"criterion": "age",
"requirement": {
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"expected_value": {
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"value": 18,
"unit": "years"
}
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}
}
}
}
},
{
"identified_line": {
"line": "* Patients refusing to sign the consent",
"criterions": [
{
"exact_snippets": "refusing to sign the consent",
"criterion": "consent form",
"requirement": {
"requirement_type": "signed",
"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "consent form",
"requirement": {
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"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patients included in another protocol within 3 months",
"criterions": [
{
"exact_snippets": "Patients included in another protocol within 3 months",
"criterion": "inclusion in another protocol",
"requirement": {
"requirement_type": "time frame",
"expected_value": {
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"value": 3,
"unit": "months"
}
}
}
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},
"logical_structure": {
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"criterion": "inclusion in another protocol",
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"value": 3,
"unit": "months"
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}
}
}
},
{
"identified_line": {
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"criterions": [
{
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"criterion": "contraindication to regional anesthesia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "coagulopathy",
"criterion": "coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "local infection",
"criterion": "local infection",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "contraindication to regional anesthesia",
"criterion": "contraindication to regional anesthesia",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
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"exact_snippets": "coagulopathy",
"criterion": "coagulopathy",
"requirement": {
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"expected_value": false
}
}
]
},
{
"and_criteria": [
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"criterion": "local infection",
"requirement": {
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"expected_value": false
}
}
]
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [
{
"identified_line": {
"line": "* Pregnant or lactating patients",
"criterions": [
{
"exact_snippets": "Pregnant",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
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"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "lactating",
"criterion": "lactation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
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"criterions": [
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"criterion": "allergy to local anesthetics",
"requirement": {
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"expected_value": false
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}
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"logical_structure": {
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"expected_value": true
}
}
]
}
},
{
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"criterions": [
{
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"criterion": "prior breast surgery",
"requirement": {
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"expected_value": true
}
},
{
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"criterion": "diagnostic biopsy",
"requirement": {
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"expected_value": false
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
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}
},
{
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"requirement": {
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"expected_value": true
}
}
]
},
"logical_structure": {
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"criterion": "failed",
"requirement": {
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"expected_value": "failed"
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},
{
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"expected_value": true
}
}
]
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"logical_structure": {
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"requirement": {
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"expected_value": "failed"
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],
"failed_miscellaneous": []
}