Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2026-01-01 @ 5:00 AM
Study NCT ID:
NCT02256228
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2014-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery
Sponsor:
Göteborg University
Organization:
Study Overview
Official Title:
Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study
Status:
COMPLETED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IPLA
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.
The parameters that would be evaluated are inflammatory markers, postoperative morbidity, pain intensity, consumption of morphine, cognitive function and progression-free survival.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: