{
    "info": {
        "nct_id": "NCT04258631",
        "official_title": "Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial",
        "inclusion_criteria": "* Elective surgery for suspected (based on consulting surgeon's opinion-imaging, laboratory [lab], pathology [path]) gynecological malignancy, enhanced recovery after surgery (ERAS) protocol\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "* Inability to read or understand English\n* Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg\n* Chronic pain syndromes such as fibromyalgia\n* Extensive surgery planned (surrogate for post-operative [postop] pain): Planned intensive care unit (ICU) admission, abdominoperineal resection, exenteration, use of intraoperative radiation (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC)\n* Contraindication to neuraxial analgesia:\n\n  * Coagulopathy\n\n    * International normalized ratio (INR) > 1.2 current or predicted after surgery (e.g. planned right hepatic resection)\n    * Thrombocytopenia. Platelets (plts) < 100\n    * Hemophiliac disease states (hemophilia, von Willebrand disease, etc.)\n    * Patients receiving antithrombotic or thrombolytic therapy are excluded according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines\n  * Localized infection at the potential site of injection\n  * Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy\n* Patients with stage 4 or 5 kidney disease (glomerular filtration rate [GFR] less than 30 ml/min per 1.73 m^2)\n* Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics\n* Current pregnancy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Elective surgery for suspected (based on consulting surgeon's opinion-imaging, laboratory [lab], pathology [path]) gynecological malignancy, enhanced recovery after surgery (ERAS) protocol",
            "criterions": [
                {
                    "exact_snippets": "Elective surgery for suspected ... gynecological malignancy",
                    "criterion": "gynecological malignancy",
                    "requirements": [
                        {
                            "requirement_type": "suspicion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "enhanced recovery after surgery (ERAS) protocol",
                    "criterion": "ERAS protocol",
                    "requirements": [
                        {
                            "requirement_type": "adherence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Inability to read or understand English",
            "criterions": [
                {
                    "exact_snippets": "Inability to read or understand English",
                    "criterion": "English language comprehension",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg",
            "criterions": [
                {
                    "exact_snippets": "Prehospitalization narcotic use ... weekly average daily oral morphine equivalent of > 20 mg",
                    "criterion": "prehospitalization narcotic use",
                    "requirements": [
                        {
                            "requirement_type": "weekly average daily oral morphine equivalent",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic pain syndromes such as fibromyalgia",
            "criterions": [
                {
                    "exact_snippets": "Chronic pain syndromes such as fibromyalgia",
                    "criterion": "chronic pain syndromes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fibromyalgia",
                    "criterion": "fibromyalgia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Extensive surgery planned (surrogate for post-operative [postop] pain): Planned intensive care unit (ICU) admission, abdominoperineal resection, exenteration, use of intraoperative radiation (IORT), hyperthermic intraperitoneal chemotherapy (HIPEC)",
            "criterions": [
                {
                    "exact_snippets": "Extensive surgery planned",
                    "criterion": "extensive surgery",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Planned intensive care unit (ICU) admission",
                    "criterion": "intensive care unit (ICU) admission",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominoperineal resection",
                    "criterion": "abdominoperineal resection",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "exenteration",
                    "criterion": "exenteration",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "use of intraoperative radiation (IORT)",
                    "criterion": "intraoperative radiation (IORT)",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hyperthermic intraperitoneal chemotherapy (HIPEC)",
                    "criterion": "hyperthermic intraperitoneal chemotherapy (HIPEC)",
                    "requirements": [
                        {
                            "requirement_type": "planned",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Contraindication to neuraxial analgesia:",
            "criterions": [
                {
                    "exact_snippets": "Contraindication to neuraxial analgesia",
                    "criterion": "neuraxial analgesia",
                    "requirements": [
                        {
                            "requirement_type": "contraindication",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coagulopathy",
            "criterions": [
                {
                    "exact_snippets": "Coagulopathy",
                    "criterion": "coagulopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* International normalized ratio (INR) > 1.2 current or predicted after surgery (e.g. planned right hepatic resection)",
            "criterions": [
                {
                    "exact_snippets": "International normalized ratio (INR) > 1.2",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "predicted after surgery",
                    "criterion": "INR",
                    "requirements": [
                        {
                            "requirement_type": "prediction",
                            "expected_value": "after surgery"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Thrombocytopenia. Platelets (plts) < 100",
            "criterions": [
                {
                    "exact_snippets": "Thrombocytopenia",
                    "criterion": "thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Platelets (plts) < 100",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 100,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemophiliac disease states (hemophilia, von Willebrand disease, etc.)",
            "criterions": [
                {
                    "exact_snippets": "Hemophiliac disease states (hemophilia, von Willebrand disease, etc.)",
                    "criterion": "hemophiliac disease states",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving antithrombotic or thrombolytic therapy are excluded according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving antithrombotic or thrombolytic therapy are excluded",
                    "criterion": "antithrombotic or thrombolytic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Localized infection at the potential site of injection",
            "criterions": [
                {
                    "exact_snippets": "Localized infection at the potential site of injection",
                    "criterion": "localized infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy",
            "criterions": [
                {
                    "exact_snippets": "Significant developmental or structural spinal abnormalities",
                    "criterion": "spinal abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "spina bifida",
                    "criterion": "spina bifida",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "tethered spinal cord",
                    "criterion": "tethered spinal cord",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "lumbar spinal fusion",
                    "criterion": "lumbar spinal fusion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active lumbar radiculopathy",
                    "criterion": "lumbar radiculopathy",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with stage 4 or 5 kidney disease (glomerular filtration rate [GFR] less than 30 ml/min per 1.73 m^2)",
            "criterions": [
                {
                    "exact_snippets": "stage 4 or 5 kidney disease",
                    "criterion": "kidney disease stage",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "4",
                                "5"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "glomerular filtration rate [GFR] less than 30 ml/min per 1.73 m^2",
                    "criterion": "glomerular filtration rate (GFR)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "ml/min per 1.73 m^2"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics",
            "criterions": [
                {
                    "exact_snippets": "Intolerance or allergy to opioids",
                    "criterion": "opioids",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Intolerance or allergy to ... acetaminophen",
                    "criterion": "acetaminophen",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Intolerance or allergy to ... amide-type local anesthetics",
                    "criterion": "amide-type local anesthetics",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "allergy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Current pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "current"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}