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Endovenous Lidocaine and Serum Cytokines Concentration

Primary Purpose

Cholelithiasis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lidocaine
Saline solution
Sponsored by
Universidade Federal de Santa Maria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring cholelithiasis, Cytokines, under general anesthesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Lidocaine

    Placebo

    Arm Description

    Group treated with lidocaine solution

    Group treated with saline solution

    Outcomes

    Primary Outcome Measures

    The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.

    Secondary Outcome Measures

    The secondary outcome was measure of citokynes IL-1 levels
    A blood sample was collected by the author or by the anesthetist of the procedure to measure IL-1, IL-6, IL-10, TNF α and IFN γ levels immediately at the end of the surgery and 24 hours after. The difference of these markers between the two groups also featured secondary outcome. The samples were centrifuged and the serum was separated in Eppendorfs and then frozen at - 70 Celsius degrees, for posterior simultaneous analysis. The biochemical responsible for this analysis also did not have contact with the group to which participants belonged.
    The secondary outcome was measure of citokynes IL-6 levels
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    The secondary outcome was measure of citokynes IL-10 levels
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    The secondary outcome was measure of citokynes TNF levels
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    The secondary outcome was measure of citokynes IFN γ levels
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.

    Full Information

    First Posted
    February 4, 2015
    Last Updated
    February 9, 2015
    Sponsor
    Universidade Federal de Santa Maria
    Collaborators
    Universidade Federal de Santa Catarina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02363699
    Brief Title
    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

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2013 (undefined)
    Primary Completion Date
    November 2013 (Actual)
    Study Completion Date
    January 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade Federal de Santa Maria
    Collaborators
    Universidade Federal de Santa Catarina

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cholelithiasis
    Keywords
    cholelithiasis, Cytokines, under general anesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Lidocaine
    Arm Type
    Active Comparator
    Arm Description
    Group treated with lidocaine solution
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Group treated with saline solution
    Intervention Type
    Drug
    Intervention Name(s)
    Lidocaine
    Other Intervention Name(s)
    Xilocayne, Lidocaine hydrochloride
    Intervention Description
    Lidocaine was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure. Solution of 0,3% lidocaine was used, so that the infusion rate was equal to the weight of the patient.
    Intervention Type
    Drug
    Intervention Name(s)
    Saline solution
    Intervention Description
    Saline solution was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure.
    Primary Outcome Measure Information:
    Title
    The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
    Description
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    The secondary outcome was measure of citokynes IL-1 levels
    Description
    A blood sample was collected by the author or by the anesthetist of the procedure to measure IL-1, IL-6, IL-10, TNF α and IFN γ levels immediately at the end of the surgery and 24 hours after. The difference of these markers between the two groups also featured secondary outcome. The samples were centrifuged and the serum was separated in Eppendorfs and then frozen at - 70 Celsius degrees, for posterior simultaneous analysis. The biochemical responsible for this analysis also did not have contact with the group to which participants belonged.
    Time Frame
    24 hours.
    Title
    The secondary outcome was measure of citokynes IL-6 levels
    Description
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    Time Frame
    24 hours
    Title
    The secondary outcome was measure of citokynes IL-10 levels
    Description
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    Time Frame
    24 hours
    Title
    The secondary outcome was measure of citokynes TNF levels
    Description
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    Time Frame
    24 hours
    Title
    The secondary outcome was measure of citokynes IFN γ levels
    Description
    The primary endpoint was the effect of lidocaine on postoperative pain within the first 24 hours. Three interns who participante of the study applied VNS to measure the intensity of pain at rest and when coughing 1, 2, 4, 12 and 24 hours after surgery.
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Juliano Ferreira, PhD
    Organizational Affiliation
    Federal University of Santa Catarina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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