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Clinical Trial 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.


Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02363699
Study type Interventional
Source Universidade Federal de Santa Maria
Contact
Status Completed
Phase Phase 4
Start date July 2013
Completion date January 2014

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