NCT02256228

Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Göteborg University · Academic / Other
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	Ropivacaine	Active Group
DRUG	Saline	Placebo Comparator

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-10-03
• Last updated: 2019-01-15

Locations

1 site across 1 country: Sweden