Intravenous Lidocaine and ImmunityPhase 4NCT03410836
Impact of Intravenous Lidocaine During Colorectal Surgery on Pain and Immune Functions
A Phase 4 study testing intravenous lidocaine (IVL) in people with Intravenous Lidocaine and Immunity, run by Ciusss de L'Est de l'Île de Montréal at 1 site in Canada.
Trial summary
This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravenous Lidocaine and Immunity
- What is being tested?
- intravenous lidocaine (IVL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 29 Apr 2019to Jun 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA status I, II or III
- Patients older than 18 years
- Colonic surgery
- Classical management of ERAS program patients in our center
Who cannot join
- Arrhythmia, abnormal electrocardiographic , antiarrhythmic therapy
- Immunosuppressive treatments, corticosteroids or long-term NSAIDs (multiple weekly doses) or during preoperative 48 hours
- conversion intraoperative of a laparoscopic surgical technique to a laparotomy technique
- Pregnant women
- Inability to complete the questions related to this study
- Inability to use hydromorphone postoperative PCA
Show all 10Show fewer
- Intolerance or allergy to lidocaine, hydromorphone or any other drug that is included in the protocol for perioperative management
- Unexpected events leading to the exclusion:
- Difficult unplanned intubation
- Surgical complication requiring aggressive haemodynamic support (vasopressors, inotropes, transfusion)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est de l'Ile de Montréal
Montreal, Quebec, H1T2M4
Philippe Richebe, MD, PhD, 514-743-6558, philippe.richebe@umontreal.ca
About this study
Official title: Impact of Intraoperative Intravenous Lidocaine Administered During Laparoscopic Colorectal Surgery on Remifentanil Consumption, Postoperative Pain and Immune Cell Activity: A Pilot Study
This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.
Read the detailed description
Hypothesis: We hypothesize that the intravenous lidocaine (IVL) versus placebo administered during laparoscopic colorectal surgery will allow for: a reduction in intraoperative remifentanil consumption, an improvement in patients' early rehabilitation after surgery, and an enhancement of the immune profile of our patients through an increase in the balance Th1/Th2 and cellular immunity.
Background: so far, IVL was shown to have several properties: analgesic, anti-inflammatory, and anti-hyperalgesic. Its effects on rehabilitation and pain are still controversial except for abdominal surgery. To date, no study evaluated the impact of IVL in colorectal surgery on intraoperative consumption of remifentanil. Postoperative immune suppression is multifactorial and depends on the surgical traumatism, but also on the doses of opioids given during anesthesia. No study evaluated in colorectal surgery the impact of IVL on postoperative cellular immunity and on the risk of cancer recurrence.
Specific Objectives: primary objective: to reduce by 30% the consumption of remifentanil in the IVL group versus the placebo group; secondary objectives: to evaluate the quality of recovery from anesthesia in the OR (awakening and extubation time), in the PACU and on the wards (pain scores, opioid consumption with patient controlled analgesia (PCA), postoperative nausea and vomiting (PONV), transit recovery time, time in PACU and time in hospital), and to evaluate the postoperative inflammatory parameters and adaptative immune functions (Th1/Th2) until postoperative 48h.
Methods: 60 adult patients ASA 1-3 scheduled for elective laparoscopic colorectal surgery will be included in this randomized controlled trial. Randomisation will be into group Control (C) and Lidocaine (IVL). Anesthesia and monitoring will be standardized and accompanied with the monitoring of the depth of anesthesia (BISpectral index, Medtronic) and the depth of analgesia (NoL index, Medasense LTD, recorded on an observational manner). IVL group will blindly be administered intravenous 1.5 mg/kg lidocaine bolus and then 1.5 mg/kg/h until the end of the surgery as previously described. C group will receive the same amount (ml) of placebo. Statistics: a preliminary analysis (idem group C) showed that the total amount of remifentanil given for this type of surgery was 2481+/-985 mcg (duration 141+/-30Min). Considering that we wish to reduce by 30% the remifentanil consumption in the group IVL, the number of patients to be included per group is 30 (alpha 0.05 and beta 20%).
Significance/Importance: this study will evaluate the impact of IVL on intraoperative consumption of remifentanil but also on immune functions after surgery in order to reduce the risk of cancer recurrence. If this study brings positive results, this will lead to a significant change in clinical practice of anesthesia. This is a pilot study on the immune functions, but this might bring very strong results to ask for future grants on the impact of IVL on cancer recurrence.
Study Design: Prospective, randomized controlled study. Subject Population: Adult patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia.
Sample Size: 60 patients will be evaluated in this study. Study Duration: 1 year. Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
- Conditions
- Intravenous Lidocaine and Immunity
- Being tested
- intravenous lidocaine (IVL), Placebo
- Keywords
- lidocaine, colorectal cancer, laparoscopy surgery, anesthesia, inflammation, cytokine, post-operative immunosuppression
- Medical subject headings
- Colorectal Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous lidocaine (IVL)Drug
lidocaine 2% will be used for induction (1 syringe of 5 ml, administered dose of 1.5 mg / kg) and for intra-operative infusion (1 syringe of 30 ml, infusion dose of 1.5 mg / kg / h). Lidocaine syringes and placebo will be prepared on a blinded manner so that the investigating anesthesiologist in charge of the patient in the operating room, as well as the respiratory therapist and the recovery room nurse and the floors do not know what the patient received during the anesthesia (whether IVL or placebo).
PlaceboOther
Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).
| Study group | Role | What they receive |
|---|---|---|
| intravenous lidocaine (IVL) | Experimental | Will receive during the colorectal surgery under General Anesthesia intravenous lidocaine bolus 1.5mg/kg at the beginning of anesthesia (induction) and 1.5mg/kg/h until the end of anesthesia. Receives: Drug: intravenous lidocaine (IVL) |
| Placebo | Placebo comparator | Will receive the same volume of normal saline for the entire duration of anesthesia. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg.
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine group compared with the control group.
Measured: Intra-operative, 5 hours
Secondary outcomes (12)
Evaluation of the number of remifentanil boluses given intraoperatively (n)
Evaluation of the number of remifentanil boluses given intraoperatively, based on the intraoperative NOL index from T0 which is the time of the incision
Measured: T0 to end of surgery, 5 hours
Assessment of total consumption of inhaled anesthetic desflurane in ml
The Dräger Perseus A500 that we have in each anesthesia room offers the opportunity to get the ml of halogenous gas consumed precisely, and our electronic extraction database will allow to have this data in ml per second and the total at the end of surgery
Measured: intra-operative
Evaluation of time for extubation
Evaluation of time for extubation after surgery in the operating room
Measured: post-operative 1 hour
Evaluation of the hydromorphone dose in mg used in the post-operative care unit (PACU) titration
Evaluation of the hydromorphone dose in mg used as post-operative titration immediately in the recovery room (PACU) to obtain NRS pain scores < 3/10
Measured: in recovery room, 3 hours
Evaluation of the nausea and vomiting scores, 0 to 3 scale
Evaluation of the nausea and vomiting scores (0 to 3) for the first 48 hours
Measured: 48 hours
Evaluation of the length of stay in the recovery room based on the Aldrete scores (Score from 0 to 9)
Evaluation of the length of stay in the recovery room based on the Aldrete scores (time to be ready to leave the recovery room)
Measured: in recovery room, 3 hours
total hydromorphone consumption (mg) after PACU, on wards
total hydromorphone consumption (mg given by Patient Controlled Analgesia) on wards for 48 hours
Measured: 48 hours
Evaluation of the satisfaction of the patient scale 0 to 100 (%)
Evaluation of the satisfaction of the patient as for the management of his pain for 48 hours
Measured: 48 hours postoperatively
Assessment of total hospital duration of stay in hours
Assessment of total hospital stay in hours
Measured: 7 days postoperatively
Evaluation of the time in hours required for the emission of a first gas in hours
Evaluation of the time in hours required for the emission of a first gas, a sign of resumption of normal intestinal function
Measured: 5 days postoperatively
Assessment of rehabilitation scores and cognitive functions
Assessment of rehabilitation scores and cognitive functions at 48h after surgery
Measured: 2 days
Assessment of cytokines in plasma
Assessment of inflammation parameters by blood sample for 48 hours
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2018
- Study start29 Apr 2019
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravenous Lidocaine and ImmunityStudies 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
- Parallel groups
- Model description
- Two groups of patients. Randomization into the treatment group or placebo group according to a randomization list for a total number of patients of 60.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciusss de L'Est de l'Île de Montréal
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation of Anesthesia and Resuscitation of Quebec
- Responsible party
- Principal investigator, Philippe Richebe, Ciusss de L'Est de l'Île de Montréal
- Investigators
- Philippe Richebé, MD, PhD, Principal investigator, CIUSSS Est de l'ile de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03410836
- Sponsor's protocol ID
- 2017-1066
- Status last verified
- Oct 2023
- First submitted
- 19 Jan 2018
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intraoperative Intravenous Lidocaine Administered During Laparoscopic Colorectal Surgery on Remifentanil Consumption, Postoperative Pain and Immune Cell Activity: A Pilot Study
- ClinicalTrials.gov ID
- NCT03410836
- Acronym / sponsor ID
- 2017-1066
- Conditions
- Intravenous Lidocaine and Immunity
- Keywords
- lidocaine, colorectal cancer, laparoscopy surgery, anesthesia, inflammation, cytokine, post-operative immunosuppression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ciusss de L'Est de l'Île de MontréalUniversity, hospital or other
- Collaborators
- Foundation of Anesthesia and Resuscitation of Quebec
- Study start
- 29 Apr 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 Jan 2018 (actual)
- 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.
This study evaluates the impact of intraoperative intravenous lidocaine administered during laparoscopic colorectal surgery on the intraoperative remifentanil consumption as well as postoperative pain and opioid requirements. It will evaluate immune cell activity for 48hours after surgical stress and general anesthesia with or without intravenous lidocaine.
Detailed description
Hypothesis: We hypothesize that the intravenous lidocaine (IVL) versus placebo administered during laparoscopic colorectal surgery will allow for: a reduction in intraoperative remifentanil consumption, an improvement in patients' early rehabilitation after surgery, and an enhancement of the immune profile of our patients through an increase in the balance Th1/Th2 and cellular immunity.
Background: so far, IVL was shown to have several properties: analgesic, anti-inflammatory, and anti-hyperalgesic. Its effects on rehabilitation and pain are still controversial except for abdominal surgery. To date, no study evaluated the impact of IVL in colorectal surgery on intraoperative consumption of remifentanil. Postoperative immune suppression is multifactorial and depends on the surgical traumatism, but also on the doses of opioids given during anesthesia. No study evaluated in colorectal surgery the impact of IVL on postoperative cellular immunity and on the risk of cancer recurrence.
Specific Objectives: primary objective: to reduce by 30% the consumption of remifentanil in the IVL group versus the placebo group; secondary objectives: to evaluate the quality of recovery from anesthesia in the OR (awakening and extubation time), in the PACU and on the wards (pain scores, opioid consumption with patient controlled analgesia (PCA), postoperative nausea and vomiting (PONV), transit recovery time, time in PACU and time in hospital), and to evaluate the postoperative inflammatory parameters and adaptative immune functions (Th1/Th2) until postoperative 48h.
Methods: 60 adult patients ASA 1-3 scheduled for elective laparoscopic colorectal surgery will be included in this randomized controlled trial. Randomisation will be into group Control (C) and Lidocaine (IVL). Anesthesia and monitoring will be standardized and accompanied with the monitoring of the depth of anesthesia (BISpectral index, Medtronic) and the depth of analgesia (NoL index, Medasense LTD, recorded on an observational manner). IVL group will blindly be administered intravenous 1.5 mg/kg lidocaine bolus and then 1.5 mg/kg/h until the end of the surgery as previously described. C group will receive the same amount (ml) of placebo. Statistics: a preliminary analysis (idem group C) showed that the total amount of remifentanil given for this type of surgery was 2481+/-985 mcg (duration 141+/-30Min). Considering that we wish to reduce by 30% the remifentanil consumption in the group IVL, the number of patients to be included per group is 30 (alpha 0.05 and beta 20%).
Significance/Importance: this study will evaluate the impact of IVL on intraoperative consumption of remifentanil but also on immune functions after surgery in order to reduce the risk of cancer recurrence. If this study brings positive results, this will lead to a significant change in clinical practice of anesthesia. This is a pilot study on the immune functions, but this might bring very strong results to ask for future grants on the impact of IVL on cancer recurrence.
Study Design: Prospective, randomized controlled study. Subject Population: Adult patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia.
Sample Size: 60 patients will be evaluated in this study. Study Duration: 1 year. Study Center: Maisonneuve-Rosemont Hospital, CIUSSS de l'Est de l'Ile de Montreal, Montreal, Quebec, Canada.
Adverse Events: None expected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Two groups of patients. Randomization into the treatment group or placebo group according to a randomization list for a total number of patients of 60.
| Arm | Type | Receives |
|---|---|---|
| intravenous lidocaine (IVL) | Experimental | Drug: intravenous lidocaine (IVL)Will receive during the colorectal surgery under General Anesthesia intravenous lidocaine bolus 1.5mg/kg at the beginning of anesthesia (induction) and 1.5mg/kg/h until the end of anesthesia. |
| Placebo | Placebo comparator | Other: PlaceboWill receive the same volume of normal saline for the entire duration of anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA status I, II or III
- Patients older than 18 years
- Colonic surgery
- Classical management of ERAS program patients in our center
Key exclusion criteria (10 listed)
- Arrhythmia, abnormal electrocardiographic , antiarrhythmic therapy
- Immunosuppressive treatments, corticosteroids or long-term NSAIDs (multiple weekly doses) or during preoperative 48 hours
- conversion intraoperative of a laparoscopic surgical technique to a laparotomy technique
- Pregnant women
- Inability to complete the questions related to this study
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 lidocaine (IVL)lidocaine 2% will be used for induction (1 syringe of 5 ml, administered dose of 1.5 mg / kg) and for intra-operative infusion (1 syringe of 30 ml, infusion dose of 1.5 mg / kg / h). Lidocaine syringes and placebo will be prepared on a blinded manner so that the investigating anesthesiologist in charge of the patient in the operating room, as well as the respiratory therapist and the recovery room nurse and the floors do not know what the patient received during the anesthesia (whether IVL or placebo). | Drug | intravenous lidocaine (IVL) |
| PlaceboGroup Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL). | Other | Placebo |
Primary outcome
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg.
Time frame: Intra-operative, 5 hours
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine group compared with the control group.
12 secondary outcomes
Evaluation of the number of remifentanil boluses given intraoperatively (n)
Time frame: T0 to end of surgery, 5 hours
Assessment of total consumption of inhaled anesthetic desflurane in ml
Time frame: intra-operative
Evaluation of time for extubation
Time frame: post-operative 1 hour
Evaluation of the hydromorphone dose in mg used in the post-operative care unit (PACU) titration
Time frame: in recovery room, 3 hours
Evaluation of the nausea and vomiting scores, 0 to 3 scale
Time frame: 48 hours
Evaluation of the length of stay in the recovery room based on the Aldrete scores (Score from 0 to 9)
Time frame: in recovery room, 3 hours
total hydromorphone consumption (mg) after PACU, on wards
Time frame: 48 hours
Evaluation of the satisfaction of the patient scale 0 to 100 (%)
Time frame: 48 hours postoperatively
Assessment of total hospital duration of stay in hours
Time frame: 7 days postoperatively
Evaluation of the time in hours required for the emission of a first gas in hours
Time frame: 5 days postoperatively
Assessment of rehabilitation scores and cognitive functions
Time frame: 2 days
Assessment of cytokines in plasma
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Intravenous Lidocaine and Immunity
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.
Philippe Richebé, MD, PhD principal investigator
CIUSSS Est de l'ile de Montreal
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 (IVL) in people with Intravenous Lidocaine and Immunity, run by Ciusss de L'Est de l'Île de Montréal 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 4 inclusion and 10 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 18 Oct 2023. 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 Philippe Richebé, MD PhD (514-743-6558, philippe.richebe@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of total intraoperative remifentanil consumption by 30% in the intravenous lidocaine ("IVL") group compared with the control group ("C"). Total consumption of remifentanil in mcg. (time frame: Intra-operative, 5 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 18 Oct 2023.