Pain Clinical Trial
Official title:
Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study
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.
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