CholelithiasisPhase 4NCT02363699
Endovenous Lidocaine and Serum Cytokines Concentration
A Phase 4 study testing Lidocaine and Saline solution in people with Cholelithiasis, run by Universidade Federal de Santa Maria.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Lidocaine and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jan 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age over 18 years and
- physical status according to the American Society of Anesthesiologists (ASA) I and II
Who cannot join
- 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.
About this study
Official title: Effect of Endovenous Lidocaine on Analgesia and Serum Cytokines Concentration: Randomized and Double-blind Trial
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.
Read the 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.
- Conditions
- Cholelithiasis
- Being tested
- Lidocaine, Saline solution
- Keywords
- cholelithiasis, Cytokines, under general anesthesia
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xilocayne, Lidocaine hydrochloride
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.
Saline solutionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Group treated with lidocaine solution Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | Group treated with saline solution Receives: Drug: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours
Secondary outcomes (5)
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.
Measured: 24 hours.
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.
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2015 (estimated)
- Study startJul 2013
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal de Santa Catarina
- Responsible party
- Principal investigator, Juliano Ferreira, Universidade Federal de Santa Maria
- Investigators
- Juliano Ferreira, PhD, Principal investigator, Federal University of Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02363699
- Sponsor's protocol ID
- LIDOCAINE X CYTOCINES
- Status last verified
- Feb 2015
- First submitted
- 4 Feb 2015
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Endovenous Lidocaine on Analgesia and Serum Cytokines Concentration: Randomized and Double-blind Trial
- ClinicalTrials.gov ID
- NCT02363699
- Acronym / sponsor ID
- LIDOCAINE X CYTOCINES
- Conditions
- Cholelithiasis
- Keywords
- cholelithiasis, Cytokines, under general anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Collaborators
- Universidade Federal de Santa Catarina
- Study start
- Jul 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 16 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: LidocaineGroup treated with lidocaine solution |
| Placebo | Placebo comparator | Drug: Saline solutionGroup treated with saline solution |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 18 years and
- physical status according to the American Society of Anesthesiologists (ASA) I and II
Key exclusion criteria (8 listed)
- patients older than 75 years,
- patients with heart disease,
- patients with history of:
- the presentation of adverse effects during the intervention or postoperative complications, and the conversion to open surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: Xilocayne, Lidocaine hydrochlorideLidocaine 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. | Drug | Lidocaine |
| Saline solutionSaline 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. | Drug | Placebo |
Primary outcome
The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores
Time frame: 24 hours
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.
5 secondary outcomes
The secondary outcome was measure of citokynes IL-1 levels
Time frame: 24 hours.
The secondary outcome was measure of citokynes IL-6 levels
Time frame: 24 hours
The secondary outcome was measure of citokynes IL-10 levels
Time frame: 24 hours
The secondary outcome was measure of citokynes TNF levels
Time frame: 24 hours
The secondary outcome was measure of citokynes IFN γ levels
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliano Ferreira, PhD principal investigator
Federal University of Santa Catarina
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine and Saline solution in people with Cholelithiasis, run by Universidade Federal de Santa Maria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was pain intensity as assessed by visual analogical scale (VAS) scores (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.