Clinical trial NCT02363699: Endovenous Lidocaine and Serum Cytokines Concentration
Official title: Effect of Endovenous Lidocaine on Analgesia and Serum Cytokines Concentration: Randomized and Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cholelithiasis
Keywords: cholelithiasis
Cytokines
under general anesthesia
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
Collaborators: name: Universidade Federal de Santa Catarina
First posted: 2015-02-16
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* age over 18 years and
* physical status according to the American Society of Anesthesiologists (ASA) I and II

Exclusion Criteria:

* patients older than 75 years,
* patients with heart disease,
* patients with history of:

  * kidney failure,
  * liver failure,
  * psychiatric disorder,
  * chronic use of opioids or medications that could cause induction of liver enzymes (anticonvulsants).
* the presentation of adverse effects during the intervention or postoperative complications, and the conversion to open surgery.

Primary outcomes:
measure: The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
timeFrame: 24 hours
Secondary outcomes:
measure: The secondary outcome was measure of citokynes IL-1 levels
timeFrame: 24 hours.
measure: The secondary outcome was measure of citokynes IL-6 levels
timeFrame: 24 hours
measure: The secondary outcome was measure of citokynes IL-10 levels
timeFrame: 24 hours
measure: The secondary outcome was measure of citokynes TNF levels
timeFrame: 24 hours
measure: The secondary outcome was measure of citokynes IFN γ levels
timeFrame: 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of Santa Catarina
name: Juliano Ferreira, PhD
role: PRINCIPAL_INVESTIGATOR
References: