{
"info": {
"nct_id": "NCT06252662",
"official_title": "Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in an Erector Spinae Plane Block for Mastectomies in Cancer Patients: a Randomized Control Trial",
"inclusion_criteria": "* Patients requiring any variation of mastectomy with or without axillary lymph node dissection.\n* Patient agrees to a peripheral nerve block.\n* Patient agrees to be a study participant.\n* APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical/surgical history.\n* Surgeon agrees with the block plan by APS.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* Patient declines a peripheral nerve block.\n* Patient declines to be a study participant.\n* APS team believes a peripheral nerve block is not clinically indicated.\n* Surgeon does not want a peripheral nerve block.\n* Patient has allergy to local anesthestic.\n* Patient has an active infection at the site of the peripheral nerve block.\n* Patient with pre-existing neural deficits along the distribution of the block.\n* Patient with coagulopathy.\n* Patient taking antithrombotic drugs outside the ASRA guidelines.\n* Patients weight is less that 50 kg due to concerns for local anesthetic toxicity syndrome.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patient agrees to a peripheral nerve block.",
"criterions": [
{
"exact_snippets": "Patient agrees to a peripheral nerve block.",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "consent",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient agrees to a peripheral nerve block.",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "consent",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patient agrees to be a study participant.",
"criterions": [
{
"exact_snippets": "Patient agrees to be a study participant.",
"criterion": "study participation agreement",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient agrees to be a study participant.",
"criterion": "study participation agreement",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical/surgical history.",
"criterions": [
{
"exact_snippets": "peripheral nerve block would be appropriate for the patient",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "appropriateness",
"expected_value": true
}
},
{
"exact_snippets": "reviewing medical/surgical history",
"criterion": "medical/surgical history",
"requirement": {
"requirement_type": "review",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "peripheral nerve block would be appropriate for the patient",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "appropriateness",
"expected_value": true
}
},
{
"exact_snippets": "reviewing medical/surgical history",
"criterion": "medical/surgical history",
"requirement": {
"requirement_type": "review",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Surgeon agrees with the block plan by APS.",
"criterions": [
{
"exact_snippets": "Surgeon agrees with the block plan by APS.",
"criterion": "surgeon agreement",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgeon agrees with the block plan by APS.",
"criterion": "surgeon agreement",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"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"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
}
}
],
"exclusion_lines": [
{
"identified_line": {
"line": "* Patient declines a peripheral nerve block.",
"criterions": [
{
"exact_snippets": "Patient declines a peripheral nerve block.",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "consent",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient declines a peripheral nerve block.",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "consent",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Patient declines to be a study participant.",
"criterions": [
{
"exact_snippets": "Patient declines to be a study participant.",
"criterion": "study participation consent",
"requirement": {
"requirement_type": "consent",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient declines to be a study participant.",
"criterion": "study participation consent",
"requirement": {
"requirement_type": "consent",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* APS team believes a peripheral nerve block is not clinically indicated.",
"criterions": [
{
"exact_snippets": "peripheral nerve block is not clinically indicated",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "clinical indication",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "peripheral nerve block is not clinically indicated",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "clinical indication",
"expected_value": false
}
},
{
"exact_snippets": "APS team believes",
"criterion": "APS team belief",
"requirement": {
"requirement_type": "belief",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Surgeon does not want a peripheral nerve block.",
"criterions": [
{
"exact_snippets": "Surgeon does not want a peripheral nerve block.",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "preference",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Surgeon does not want a peripheral nerve block.",
"criterion": "peripheral nerve block",
"requirement": {
"requirement_type": "preference",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Patient has allergy to local anesthestic.",
"criterions": [
{
"exact_snippets": "allergy to local anesthestic",
"criterion": "allergy to local anesthestic",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "allergy to local anesthestic",
"criterion": "allergy to local anesthestic",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patient has an active infection at the site of the peripheral nerve block.",
"criterions": [
{
"exact_snippets": "active infection at the site of the peripheral nerve block",
"criterion": "infection at the site of the peripheral nerve block",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "active infection at the site of the peripheral nerve block",
"criterion": "infection at the site of the peripheral nerve block",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patient with pre-existing neural deficits along the distribution of the block.",
"criterions": [
{
"exact_snippets": "pre-existing neural deficits",
"criterion": "neural deficits",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "along the distribution of the block",
"criterion": "distribution of the block",
"requirement": {
"requirement_type": "location",
"expected_value": "along the distribution of the block"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "pre-existing neural deficits",
"criterion": "neural deficits",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "along the distribution of the block",
"criterion": "distribution of the block",
"requirement": {
"requirement_type": "location",
"expected_value": "along the distribution of the block"
}
}
]
}
},
{
"identified_line": {
"line": "* Patient with coagulopathy.",
"criterions": [
{
"exact_snippets": "Patient with coagulopathy",
"criterion": "coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patient with coagulopathy",
"criterion": "coagulopathy",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Patient taking antithrombotic drugs outside the ASRA guidelines.",
"criterions": [
{
"exact_snippets": "Patient taking antithrombotic drugs outside the ASRA guidelines.",
"criterion": "antithrombotic drug use",
"requirement": {
"requirement_type": "compliance",
"expected_value": "outside ASRA guidelines"
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patient taking antithrombotic drugs outside the ASRA guidelines.",
"criterion": "antithrombotic drug use",
"requirement": {
"requirement_type": "compliance",
"expected_value": "outside ASRA guidelines"
}
}
}
},
{
"identified_line": {
"line": "* Patients weight is less that 50 kg due to concerns for local anesthetic toxicity syndrome.",
"criterions": [
{
"exact_snippets": "Patients weight is less that 50 kg",
"criterion": "weight",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "kg"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients weight is less that 50 kg",
"criterion": "weight",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<",
"value": 50,
"unit": "kg"
}
}
}
]
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients requiring any variation of mastectomy with or without axillary lymph node dissection.",
"criterions": [
{
"exact_snippets": "Patients requiring any variation of mastectomy",
"criterion": "mastectomy",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "with or without axillary lymph node dissection",
"criterion": "axillary lymph node dissection",
"requirement": {
"requirement_type": "necessity",
"expected_value": [
"with",
"without"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients requiring any variation of mastectomy",
"criterion": "mastectomy",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"or_criteria": [
{
"exact_snippets": "with or without axillary lymph node dissection",
"criterion": "axillary lymph node dissection",
"requirement": {
"requirement_type": "necessity",
"expected_value": "with"
}
},
{
"exact_snippets": "with or without axillary lymph node dissection",
"criterion": "axillary lymph node dissection",
"requirement": {
"requirement_type": "necessity",
"expected_value": "without"
}
}
]
}
]
}
]
}
}
],
"failed_exclusion": [],
"failed_miscellaneous": []
}