Spots Global Cancer Trial Database for Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery
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Trial Identification
Brief Title: Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery
Official Title: Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study
Study ID: NCT02256228
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Dept. of Gynecological Surgery and Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, , Sweden
Contact Details
Name: Sven-Egron Thorn, MD PhD
Affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
Role: PRINCIPAL_INVESTIGATOR
Name: Anil Gupta, MD PhD
Affiliation: Dept. of Anesthesia and Intensive Care, Orebro University Hospital, Orebro, Sweden
Role: STUDY_CHAIR
Name: Sven-Erik Ricksten, MD PhD
Affiliation: Dept. of Anesthesia and Intensive Care, Sahlgrenska University Hospital, Goteborg, Sweden
Role: STUDY_CHAIR
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