Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02363699
Status:
COMPLETED
Last Update Posted:
2015-02-16
First Post:
2015-02-04
Brief Title:
Endovenous Lidocaine and Serum Cytokines Concentration
Sponsor:
Universidade Federal de Santa Maria
Organization:
Universidade Federal de Santa Maria
Study Overview
Official Title:
Effect of Endovenous Lidocaine on Analgesia and Serum Cytokines Concentration Randomized and Double-blind Trial
Status:
COMPLETED
Status Verified Date:
2015-02
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:
None
Brief Summary:
Ineffective treatment of postoperative pain may cause organic damage and chronic pain Nevertheless opioids the leading drugs used for this purpose present side effects that sometimes restrict their usability In a multimodal context new postoperative analgesia techniques have been developed focusing in the reduction of opioid use and their adverse effects as well as postoperative chronic pain prevention In this background continuous intravenous infusion of lidocaine during perioperative period has shown to be promising This trial aimed to compare postoperative analgesia opioid consumption duration of ileus and length of hospital stay and IL-1 IL-6 IL-10 α TNF and γ IFN levels in patients undergoing to laparoscopic cholecystectomies who received intravenous lidocaine in comparison to a control group Intravenous lidocaine in the perioperative period of laparoscopic cholecystectomies was not able to reduce postoperative pain opioid consumption and duration of ileus or length of hospital stay However its anti-inflammatory effect was evidenced by the significant changes in the studied cytokines
Detailed Description:
Forty-four patients undergoing laparoscopic cholecystectomy under general anesthesia were randomly allocated in two groups The first group received intravenous lidocaine infusion during the procedure until one hour postoperatively meanwhile the second group received intravenous saline for the same period of time The intervention was double-blind In the postoperative period both groups received dipyrone and morphine PCA Pain was assessed by Visual Numeric Scale VNS at rest and when coughing at 1st 2nd 4th 12th e 24th hour after the end of the surgery Blood samples for cytokines measurement were taken at the end of procedure and 24 hours later The total morphine PCA demand the time for the first flatus and the length of hospital stay were also recorded and compared
Study Oversight
Has Oversight DMC:
None
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?:
None