Endovenous Lidocaine and Serum Cytokines Concentration
Primary Purpose
Cholelithiasis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Lidocaine
Saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Cholelithiasis focused on measuring cholelithiasis, Cytokines, under general anesthesia
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.
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
NCT ID
NCT02363699
First Posted
February 4, 2015
Last Updated
February 9, 2015
Sponsor
Universidade Federal de Santa Maria
Collaborators
Universidade Federal de Santa Catarina
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
Learn more about this trial
Endovenous Lidocaine and Serum Cytokines Concentration
We'll reach out to this number within 24 hrs