Colon CancerPhase 2NCT01155440
Bowel Function After Laparoscopic Colon Surgery: Effect of IV Lidocaine
A Phase 2 study testing Lidocaine and Thoracic epidural block in people with Colon Cancer and Inflammatory Bowel Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- What is being tested?
- Lidocaine and Thoracic epidural block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Oct 2011
- Phase
- Phase 2
- 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
- scheduled to undergo laparoscopic colorectal resection
Who cannot join
- patients who have trouble to understand, read or communicate either in French or in English
- dementia
- patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
- patients suffering from severe cardiac or respiratory disease (status ASA IV
- patients suffering from metastatic carcinoma
- patients who have a history of chemoradiation within the six months preceding surgery
Show all 9Show fewer
- allergy to lidocaine
- morbid obesity
- patients with chronic opioid use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine
Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.
Read the detailed description
The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection.
The study focuses on patients with colorectal disease, which receive the laparoscopic (assisted) surgical approach.
It is hypothesized that in those patients receiving perioperative and post-operative intravenous lidocaine, bowel function recovery will be faster, probably as a result of a significant opioid sparing, less pain and attenuated inflammatory response.
- Conditions
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- Being tested
- Lidocaine, Thoracic epidural block
- Keywords
- 60 patients scheduled to have a colorectal surgery, recruit at Montreal General Hospital
- Medical subject headings
- Colonic Neoplasms, Inflammatory Bowel Diseases, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Xylocaine
1% Lidocaine 1mg/kg/hr IV drip x 48hr
Thoracic epidural blockProcedure or surgery
Also called Thoracic Epidural analgesia
0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
| Study group | Role | What they receive |
|---|---|---|
| LIDOCAINE group | Experimental | Beside general anesthesia, patients will receive intravenous lidocaine bolus 1.5 mg/kg just prior induction and an infusion of lidocaine 2mg/kg/h will be started and maintained during the whole surgical procedure. Entering the recovery room, this infusion will be decreased at the rate of 1mg/kg/hour for the 48 first hours Receives: Drug: Lidocaine |
| Epidural group | Active comparator | Beside general anesthesia, patient will receive epidural freezing medication for 48 hours. Receives: Procedure: Thoracic epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of bowel function
Measured: 72 hours after an operation
Secondary outcomes (1)
Pain intensity
Visual analog score pain (from 0-10) at rest, on walking and coughing at 24, 48 and 72 hours after an operation are assessed.
Measured: within 72 hours after an operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Baldini, Assistant Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Mingkwan Wongyingsinn, Fellow, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155440
- Sponsor's protocol ID
- GEN-06-023(1)
- Status last verified
- Nov 2011
- First submitted
- 30 Jun 2010
- Last updated
- 28 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wongyingsinn M, Baldini G, Charlebois P, Liberman S, Stein B, Carli F. Intravenous lidocaine versus thoracic epidural analgesia: a randomized controlled trial in patients undergoing laparoscopic colorectal surgery using an enhanced recovery program. Reg Anesth Pain Med. 2011 May-Jun;36(3):241-8. doi: 10.1097/AAP.0b013e31820d4362.
PubMed 21519309
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restoration of Bowel Function After Laparoscopic Colorectal Surgery: Effect of Intravenous Lidocaine
- ClinicalTrials.gov ID
- NCT01155440
- Acronym / sponsor ID
- GEN-06-023(1)
- Conditions
- Colon Cancer, Inflammatory Bowel Diseases, Diverticulitis
- Keywords
- 60 patients scheduled to have a colorectal surgery, recruit at Montreal General Hospital
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 1 Jul 2010 (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.
Patients receiving perioperative intravenous lidocaine, post operative restoration of bowel movement will be faster and decrease pain intensity, opioid consumption and side effects, length of hospital stay; probably as a result of a significant opioid sparing and attenuated inflammatory response.
Detailed description
The aim of this study is to assess whether perioperative intravenous lidocaine has an impact on the early postoperative physical activity recovery of patients scheduled for laparoscopic colorectal resection.
The study focuses on patients with colorectal disease, which receive the laparoscopic (assisted) surgical approach.
It is hypothesized that in those patients receiving perioperative and post-operative intravenous lidocaine, bowel function recovery will be faster, probably as a result of a significant opioid sparing, less pain and attenuated inflammatory response.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIDOCAINE group | Experimental | Drug: LidocaineBeside general anesthesia, patients will receive intravenous lidocaine bolus 1.5 mg/kg just prior induction and an infusion of lidocaine 2mg/kg/h will be started and maintained during the whole surgical procedure. Entering the recovery room, this infusion will be decreased at the rate of 1mg/kg/hour for the 48 first hours |
| Epidural group | Active comparator | Procedure: Thoracic epidural blockBeside general anesthesia, patient will receive epidural freezing medication for 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled to undergo laparoscopic colorectal resection
Key exclusion criteria (9 listed)
- patients who have trouble to understand, read or communicate either in French or in English
- dementia
- patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity
- patients suffering from severe cardiac or respiratory disease (status ASA IV
- patients suffering from metastatic carcinoma
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: Xylocaine1% Lidocaine 1mg/kg/hr IV drip x 48hr | Drug | LIDOCAINE group |
| Thoracic epidural blockAlso: Thoracic Epidural analgesia0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr | Procedure or surgery | Epidural group |
Primary outcome
Restoration of bowel function
Time frame: 72 hours after an operation
1 secondary outcome
Pain intensity
Time frame: within 72 hours after an operation
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 28 Nov 2011.
- Derived from this study: PubMed 21519309Wongyingsinn M, Baldini G, Charlebois P, Liberman S, Stein B, Carli F. Intravenous lidocaine versus thoracic epidural analgesia: a randomized controlled trial in patients undergoing laparoscopic colorectal surgery using an enhanced recovery program. Reg Anesth Pain Med. 2011 May-Jun;36(3):241-8. doi: 10.1097/AAP.0b013e31820d4362.
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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.
Mingkwan Wongyingsinn, Fellow principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine and Thoracic epidural block in people with Colon Cancer and Inflammatory Bowel Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre 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 1 inclusion and 9 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 28 Nov 2011. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Restoration of bowel function (time frame: 72 hours after an operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01155440, which also lists 1 linked publication.
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 28 Nov 2011.