Colorectal CancerPhase 4NCT01841294
NK Activity Modulation Induced by Intravenous Lidocaine During Colorectal Laparoscopic Surgery
A Phase 4 study testing Intravenous Lidocaine and Normal saline infusion in people with Colorectal Cancer, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
Trial summary
Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Intravenous Lidocaine and Normal saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Dec 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted for resection of colorectal cancer under laparoscopic surgery
- American Society of Anesthesiologists class I-III.
- The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.
Who cannot join
- Subjects allergic to any of the study drugs.
- BMI > 35 kg/m2.
- Severe renal or hepatic failure.
- Pregnancy.
- Emergent procedure.
- Heart failure NYHA > III.
Show all 14Show fewer
- Systolic blood pressure < 90 mmHg.
- Advanced heart block (unless patient has a pacemaker).
- Unstable angina and/or myocardial infarction within past 6 weeks.
- FEV1 ≤ 0.8 L.
- Oxygen-dependent patient.
- Electrocardiographic abnormalities
- Treatment with immunosupressive drugs, corticosteroids, NSAIDS, antiarythmic
- Morphine intolerance or allergy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hôpital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Nadia godin, 1 514 252 3400 ext. 3153, ngodin.hmr@ssss.gouv.qc.ca
About this study
Official title: NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery
Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread.
A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics.
Read more
Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well.
The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.
- Conditions
- Colorectal Cancer
- Being tested
- Intravenous Lidocaine, Normal saline infusion
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous LidocaineDrug
Also called Chlorydrate de Lidocaine 2%
Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
Normal saline infusionDrug
Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Lidocaine | Experimental | Patients undergoing laparoscopic surgery for resection of colorectal cancer will benefit of an infusion of intravenous lidocaine from the induction of anesthesia untill one hour after PACU admission Receives: Drug: Intravenous Lidocaine |
| Placebo | Placebo comparator | Infusion of normal saline form the induction of anaesthesia untill one hour after PACU admission Receives: Drug: Normal saline infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosage of NKs activity after surgery
Dosage of NKs activity after surgery
Measured: compare the activity of NK cells on day 1 and day 3 after surgery
Secondary outcomes (7)
Pain scores
From the PACU to the 3rd day after surgery
Measured: pain scores from the PACU to the 3rd day after surgery
Morphine consumption
Morphine consumption from the PACU to the 3rd day after surgery
Measured: From the PACU to the 3rd day after surgery
Ileus time
time to get flattus after surgery
Measured: Day 1 and Day 3 after surgery
Surgical complications
Infections, leakage, abcess
Measured: Within 3 days after surgery
Fentanyl dose
Cumulative dose of fentanyl needed for the surgery
Measured: Operative time
Nausea and vomiting
Nausea and vomiting from the PACU to the 3rd day after surgery
Measured: From the PACU to the 3rd day after surgery
Major adverses events
Hypotension, heart rythm blocks, tachycarida, bradycardia
Measured: Start of the surgery untill one hour after PACU ad;ission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2013 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maisonneuve-Rosemont Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis-Philippe Fortier, Maisonneuve-Rosemont Hospital
- Investigators
- Louis-Philippe Fortier, M.D., Principal investigator, Maisonneuve-Rosemont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841294
- Sponsor's protocol ID
- 11077
- Status last verified
- Jan 2012
- First submitted
- 27 Feb 2013
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NK Activity Modulation by Intravenous Lidocaine During Laparoscopic Colorectal Surgery
- ClinicalTrials.gov ID
- NCT01841294
- Acronym / sponsor ID
- 11077
- Conditions
- Colorectal Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Maisonneuve-Rosemont HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Apr 2013 (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.
Surgical resection is the best treatment option for colorectal cancer. Despite this radical approach, recurrences within five years are still common. Several authors have proposed that the immunosuppressive state surrounding the perioperative period was a key element of cancer cells spread.
A particular subtype of T lymphocytes, the Natural Killer cells (NKs), is the main actor of the innate immune system. Several factors of the perioperative period can reduce activity of NKs such as stress, pain, opioids and general anaesthetics.
Lidocaine is a local anaesthetic that has been widely used intravenously for abdominal surgeries. Intravenous lidocaine has been shown to reduce pain scores, morphine consumption, ileus time and length of stay in major colorectal surgeries. It reduced markers of systemic inflammation as well.
The authors hypothesize that the use of intravenous lidocaine during laparoscopic surgeries for colorectal cancer resection will preserve NKs activity.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Lidocaine | Experimental | Drug: Intravenous LidocainePatients undergoing laparoscopic surgery for resection of colorectal cancer will benefit of an infusion of intravenous lidocaine from the induction of anesthesia untill one hour after PACU admission |
| Placebo | Placebo comparator | Drug: Normal saline infusionInfusion of normal saline form the induction of anaesthesia untill one hour after PACU admission |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients admitted for resection of colorectal cancer under laparoscopic surgery
- American Society of Anesthesiologists class I-III.
- The subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent.
Key exclusion criteria (14 listed)
- Subjects allergic to any of the study drugs.
- BMI > 35 kg/m2.
- Severe renal or hepatic failure.
- Pregnancy.
- Emergent procedure.
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 |
|---|---|---|
| Intravenous LidocaineAlso: Chlorydrate de Lidocaine 2%Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h | Drug | Intravenous Lidocaine |
| Normal saline infusionNormal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h | Drug | Placebo |
Primary outcome
Dosage of NKs activity after surgery
Time frame: compare the activity of NK cells on day 1 and day 3 after surgery
Dosage of NKs activity after surgery
7 secondary outcomes
Pain scores
Time frame: pain scores from the PACU to the 3rd day after surgery
Morphine consumption
Time frame: From the PACU to the 3rd day after surgery
Ileus time
Time frame: Day 1 and Day 3 after surgery
Surgical complications
Time frame: Within 3 days after surgery
Fentanyl dose
Time frame: Operative time
Nausea and vomiting
Time frame: From the PACU to the 3rd day after surgery
Major adverses events
Time frame: Start of the surgery untill one hour after PACU ad;ission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
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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.
Louis-Philippe Fortier, M.D. principal investigator
Maisonneuve-Rosemont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Lidocaine and Normal saline infusion in people with Colorectal Cancer, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.
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 3 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 26 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact louis-Philippe Fortier, M.D. (1 514 252 3400, fortierlp@mac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosage of NKs activity after surgery (time frame: compare the activity of NK cells on day 1 and day 3 after surgery). 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 26 Apr 2013.