Postoperative PainNCT01062906
Intravenous Lidocaine for Laparoscopic Cholecystectomy
A study testing Lidocaine and Fentanyl in people with Postoperative Pain and Opioid Consumption, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Pain, Opioid Consumption
- What is being tested?
- Lidocaine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Mar 2010
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing laparoscopic cholecystectomy
Who cannot join
- age <18 yr or > 85 yr,
- ASA physical status 3 and greater, history of hepatic failure (Child \& Pug A-C),
- renal failure (creatinine outside the normal range) or cardiac failure (NYHA I-IV),
- Adams-Stoke syndrome,
- severe degrees of sinoatrial, atrioventricular or intraventricular block,
- organ transplant,
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- diabetes mellitus type 1 and 2,
- morbid obesity (BMI > 40),
- chronic use of opioids and beta-blockers,
- known seizures,
- severe mental impairment,
- allergy to local anesthetics and to all the medications used in the study, or
- inability to understand pain assessment.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University Health Centre, Montreal General Hospital
Montreal, Quebec, H3G1A4
About this study
Official title: The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy
Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the recovery room by 30%.
The purpose of this study was to determine if an i.v. infusion of lidocaine without intraoperative opioids would reduce the amount of fentanyl to the same extent and opioids-related side effects.
- Conditions
- Postoperative Pain, Opioid Consumption
- Keywords
- intravenous lidocaine, postoperative pain, laparoscopic surgery, opioids, opioids side-effects
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin)
FentanylDrug
Fentanyl 3 mcg/Kg as bolus at the induction and a continuous infusion of normal saline (NaCl 0.9%) until the end of surgery (skin closure)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery. Receives: Drug: Fentanyl |
| Lidocaine | Active comparator | The Lidocaine group will receive lidocaine as bolus at the induction of anesthesia followed by a continuous infusion of lidocaine until the end of surgery Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fentanyl consumption (measured as fentanyl equivalents -mcg)
Measured: postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery
Secondary outcomes (2)
Pain, Static and Dynamic
Measured: On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery
Opioids side-effects
Measured: On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2010
- Study completionMar 2010
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 Postoperative PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Franco Carli, MD, professor, Principal investigator, McGill University Healt Centre, Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01062906
- Sponsor's protocol ID
- GEN#08-021
- Status last verified
- Feb 2010
- First submitted
- 3 Feb 2010
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.
PubMed 19138915
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intravenous Lidocaine on Short-term Outcomes After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01062906
- Acronym / sponsor ID
- GEN#08-021
- Conditions
- Postoperative Pain, Opioid Consumption
- Keywords
- intravenous lidocaine, postoperative pain, laparoscopic surgery, opioids, opioids side-effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 4 Feb 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.
Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic, antithrombotics and neuroprotective properties. In a previous study conducted in patients undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the recovery room by 30%.
The purpose of this study was to determine if an i.v. infusion of lidocaine without intraoperative opioids would reduce the amount of fentanyl to the same extent and opioids-related side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: FentanylThe control group receives intravenous fentanyl at the induction of anesthesia followed by a continuous infusion of lidocaine during the surgery. |
| Lidocaine | Active comparator | Drug: LidocaineThe Lidocaine group will receive lidocaine as bolus at the induction of anesthesia followed by a continuous infusion of lidocaine until the end of surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing laparoscopic cholecystectomy
Key exclusion criteria (13 listed)
- age <18 yr or > 85 yr,
- ASA physical status 3 and greater, history of hepatic failure (Child \& Pug A-C),
- renal failure (creatinine outside the normal range) or cardiac failure (NYHA I-IV),
- Adams-Stoke syndrome,
- severe degrees of sinoatrial, atrioventricular or intraventricular block,
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 |
|---|---|---|
| Lidocaine1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin) | Drug | Lidocaine |
| FentanylFentanyl 3 mcg/Kg as bolus at the induction and a continuous infusion of normal saline (NaCl 0.9%) until the end of surgery (skin closure) | Drug | Control |
Primary outcome
Fentanyl consumption (measured as fentanyl equivalents -mcg)
Time frame: postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery
2 secondary outcomes
Pain, Static and Dynamic
Time frame: On postoperative day 0 (day of surgey before beeing discharged home) and 24 hrs after the end of surgery
Opioids side-effects
Time frame: On postoperative day 0 (before beeing discharged home) and at 24 hrs after the end of surgery
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 13 Jan 2011.
- Background: PubMed 19138915Lauwick S, Kim DJ, Michelagnoli G, Mistraletti G, Feldman L, Fried G, Carli F. Intraoperative infusion of lidocaine reduces postoperative fentanyl requirements in patients undergoing laparoscopic cholecystectomy. Can J Anaesth. 2008 Nov;55(11):754-60. doi: 10.1007/BF03016348.
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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.
Franco Carli, MD, professor principal investigator
McGill University Healt Centre, Department of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine and Fentanyl in people with Postoperative Pain and Opioid Consumption, 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 13 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 13 Jan 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. 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.
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?
Fentanyl consumption (measured as fentanyl equivalents -mcg) (time frame: postoperative day 0 (day of surgery before beeing discharged home) and 24 hr after the end of surgery). 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 NCT01062906, 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 13 Jan 2011.