Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.
The aim of this study is to measure the efficacy of local anesthetics (LA) administered into the intra-peritoneal cavity compared to placebo. Our hypothesis is that the injection of local LAs intra-peritoneally would reduce post-operative pain and the inflammatory process caused by the massive release of cytokines during extensive cytoreductive surgery. The study is a controlled, parallel group, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden . Twenty mL of ropivacaine or saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen according to group randomization in order to double blind patients and all personnel involved in the study. The parameters that would be evaluated are inflammatory markers, postoperative morbidity, pain intensity, consumption of morphine, cognitive function and progression-free survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Active Group
Placebo Comparator
Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital
Gothenburg, Sweden
Inflammatory Markers
Analysis of the following inflammatory markers with Multiplex: IL(interleukin)-1β, IL-1rα, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, zBasic FGF (Fibroblast Growth Factor), Eotaxin, G-CSF (granulocyte colony stimulating factor), GM-CSF granulocyte macrophage colony stimulating factor), IFN-γ (interferon), IP-10 (immune protein), MCP-1 (monocyte chemotactic protein), MCAF (monocyte chemotactic and activating factor), MIP-1α (macrophage inflammatory protein), MIP-1β, PDGF-BB (platelet-derived growth factor), RANTES (regulated on activation, normal T cell expressed and secreted), TNF-α (tumor necrosis factor), VEGF (vascular endothelial growth factor)
Time frame: 0-48 hours postoperatively
Postoperative Morphine consumption
Total amount of Morphine consumed during the first 48 hours after surgery
Time frame: 0-48 hours postoperatively
Pain Intensity
Pain Intensity is measured with Numeric Rating Score 0-10
Time frame: 0-48 hours postoperatively
Cognitive Function
Patients will complete the following neurophysiological tests upon entering the study and within one month after surgery: Verbal Learning Test (VLT), Concept Shifting Test (CST), Letter-Digit Coding, Verbal Learning Test - Delayed Recall (VLT-D)
Time frame: 0-1 month postoperatively
Progression-free Survival
Progression-free Survival measures the length of time after treatment during which the cancer being treated does not get worse.
Time frame: 0-3 years postoperatively
Postoperative Morbidity/Complications
Measuring the numbers of Postoperative Morbidity/Complications within one month after surgery: Morbidity: * Local infections * Urinary infection (urine culture) * Pneumonia (X-ray, C-reactive protein, Fever) * Sepsis (Fever, Leucocyte count in blood, Heart Rate, Respiratory Rate) * Pleural fluid (X-ray verified) * Deep Vein Thrombosis (D-dimer, ultrasound verified) * Pulmonary embolism (Computed Tomography/ Scint-X) * Acute Myocardial Infarction (Electrocardiography, Troponin I) * Atrial fibrillation or serious arrhythmia during the first 48 hours after surgery (Electrocardiography) * Respiratory failure (prolonged mechanical ventilation) * Renal failure (Serum Creatinine, Diuresis, AKIN criteria) * Inotropic needs \> 12 hours after surgery Surgical Complications: * Intraabdominal bleeding * Leakage from anastomosis * Abdominal abscess * Paralytic ileus * Pancreatic leakage (requiring drainage)
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Time frame: 0-30 days postoperatively