Wound Infiltration With Liposomal Bupivacaine With or Without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial

MC2061

This phase IV trial studies how well liposomal bupivacaine with or without hydromorphone works in improving pain control during the first 24 hours after surgery in patients with gynecological malignancies undergoing laparotomy. Liposomal bupivacaine is routinely infiltrated into the skin surrounding the abdominal incision, and is effective in providing good relief of incisional pain. Hydromorphone is also a type of pain medication that may provide better management of deep abdominal pain. It is not yet known if giving liposomal bupivacaine with or without hydromorphone will work better in improving pain in patients with gynecological malignancies during the first 24 hours after surgery.

2020-07-09

2023-05-08

2023-05-08

Completed

Early phase I

104

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 Exclusion Criteria: * Inability to read or understand English * Prehospitalization narcotic use if weekly average daily oral morphine equivalent of \> 20 mg * Chronic pain syndromes such as fibromyalgia * 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) * Contraindication to neuraxial analgesia: * Coagulopathy * International normalized ratio (INR) \> 1.2 current or predicted after surgery (e.g. planned right hepatic resection) * Thrombocytopenia. Platelets (plts) \< 100 * Hemophiliac disease states (hemophilia, von Willebrand disease, etc.) * Patients receiving antithrombotic or thrombolytic therapy are excluded according to the American Society of Regional Anesthesia and Pain Medicine (ASRA) guidelines * Localized infection at the potential site of injection * 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 * Patients with stage 4 or 5 kidney disease (glomerular filtration rate \[GFR\] less than 30 ml/min per 1.73 m\^2) * Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics * Current pregnancy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 104, 'type': 'ACTUAL'}}

2023-05-23