Pain
Conditions
Keywords
Analgesia, Local infiltration analgesia, Pain, relief, Pain, Postoperative, Intra-peritoneal analgesia, Ropivacaine, Saline, Therapeutic Uses, Analgesics, Non-Narcotic, Analgesics, Opioids, Morphine, Pain, Postoperative Complications, Physiological Effects of Drugs, Anesthetics, Local, Anesthetic, Cytoreductive, Surgery, Cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGRopivacaine
Active Group
DRUGSaline
Placebo Comparator
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
\- Patients with widespread malignant intra-abdominal ovary cancer stadium III-IV and are operated by extensive resection of intra-abdominal viscera as well as the parietal peritoneum (cytoreductive surgery, CRS)
Exclusion criteria
* Body mass index \> 35 * American Society of Anesthesiologists classification \> 3 * Renal dysfunction * Allergic to acetylsalicylic acid * Unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Markers | 0-48 hours postoperatively | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Morphine consumption | 0-48 hours postoperatively | Total amount of Morphine consumed during the first 48 hours after surgery |
| Pain Intensity | 0-48 hours postoperatively | Pain Intensity is measured with Numeric Rating Score 0-10 |
| Cognitive Function | 0-1 month postoperatively | 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) |
| Progression-free Survival | 0-3 years postoperatively | Progression-free Survival measures the length of time after treatment during which the cancer being treated does not get worse. |
| Postoperative Morbidity/Complications | 0-30 days postoperatively | 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) |
Countries
Sweden
Outcome results
None listed