PainNCT01277835
Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control
A study testing Lidocaine Infusion in people with Pain, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether intravenous lidocaine infusion during a video-assisted chest surgery is effective in reducing the pain involved after the surgery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Lidocaine Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to Feb 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age 18-75
- Scheduled for VATS procedure
Who cannot join
- Patients receiving antiarrhythmic therapy (Class Ia, Ib, Ic) within one week of surgery
- Patients on preoperative analgesic therapy within one week of surgery
- Patients with history of drug or alcohol abuse
- Patients who are allergic to lidocaine
- Contraindication to self administered morphine (unable to understand the PCA)
- Progression of the procedure to thoracotomy
Show all 10Show fewer
- Patients who need postoperative mechanical ventilation
- Necessary major deviation from the intraoperative study protocol as per the discretion of the anesthesiologist in charge of the case
- Patients who are breastfeeding or pregnant
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements
The purpose of this study is to determine whether intravenous lidocaine infusion during a video-assisted chest surgery is effective in reducing the pain involved after the surgery. The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic surgery (VATS) reduces morphine consumption and postoperative pain.
Read the detailed description
Despite newer surgical techniques, many patients still experience moderate to severe postoperative pain after minimally invasive surgeries. Thoracoscopic surgeries are often associated with severe postoperative pain. To relieve the pain, potent narcotics have to be used, which have many side effects. Surgical patients would therefore benefit from an intra-operative analgesic regimen that is safe and effective, has minimal side effects and can reduce their postoperative narcotic requirements. Intravenous lidocaine has been shown previously to relieve cancer pain, chronic pain, and pain after other types of surgery.
- Conditions
- Pain
- Being tested
- Lidocaine Infusion, Placebo
- Keywords
- video-assisted, thoracic surgery, VATS, lidocaine infusion, VATS procedures
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine InfusionDrug
Infusion of lidocaine 3mg/min or 2mg/min during surgery
PlaceboDrug
Saline Infusion at same rate as experimental arm
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine Infusion | Experimental | Not described Receives: Drug: Lidocaine Infusion |
| Placebo | Placebo comparator | Saline Infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Rating Scale for pain with deep inspiration
Patients will be questioned about pain intensities with a deep inspiratory breath using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, and 48 hours post-initiaition of patient-controlled analgesia.
Measured: Up to 48 hrs post-initiation of patient-controlled analgesia
PCA Morphine Consumption
Patient-controlled analgesia machines will be reviewed for the total morphine doses administered at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Number of PCA Morphine Requests
PCA machines will be reviewed for total number of PCA requests at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Verbal Rating Scale for pain at rest
Patients will be questioned about pain intensities at rest using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Secondary outcomes (5)
Nausea
Patients will be questioned about the side effect of nausea at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Vomiting
Patients will be questioned about the side effect of vomiting at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Pruritus
Patients will be questioned about the side effect of pruritus at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Constipation
Patients will be questioned about the side effect of constipation at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Urinary Retention
Patients will be questioned about the side effect of urinary retention at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.
Measured: Up to 48hrs post-initiation of patient-controlled analgesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennis Ong, MD FRCPC, Principal investigator, University of Saskatchewan, Department of Anesthesiology, Perioperative Medicine, and Pain ManagementBrian Taylor, MD, Study director, Department of Anesthesiology, Perioperative Medicine, and Pain ManagementAshraf Salem, MD, Study director, Department of Anesthesiology, Perioperative Medicine, and Pain ManagementMark Slovack, MD, Study director, Department of Anesthesiology, Perioperative Medicine, and Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277835
- Sponsor's protocol ID
- VATS-lidocaine
- Status last verified
- Feb 2013
- First submitted
- 9 Apr 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements
- ClinicalTrials.gov ID
- NCT01277835
- Acronym / sponsor ID
- VATS-lidocaine
- Conditions
- Pain
- Keywords
- video-assisted, thoracic surgery, VATS, lidocaine infusion, VATS procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Jan 2011 (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.
The purpose of this study is to determine whether intravenous lidocaine infusion during a video-assisted chest surgery is effective in reducing the pain involved after the surgery. The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic surgery (VATS) reduces morphine consumption and postoperative pain.
Detailed description
Despite newer surgical techniques, many patients still experience moderate to severe postoperative pain after minimally invasive surgeries. Thoracoscopic surgeries are often associated with severe postoperative pain. To relieve the pain, potent narcotics have to be used, which have many side effects. Surgical patients would therefore benefit from an intra-operative analgesic regimen that is safe and effective, has minimal side effects and can reduce their postoperative narcotic requirements. Intravenous lidocaine has been shown previously to relieve cancer pain, chronic pain, and pain after other types of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine Infusion | Experimental | Drug: Lidocaine Infusion |
| Placebo | Placebo comparator | Drug: PlaceboSaline Infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- Age 18-75
- Scheduled for VATS procedure
Key exclusion criteria (10 listed)
- Patients receiving antiarrhythmic therapy (Class Ia, Ib, Ic) within one week of surgery
- Patients on preoperative analgesic therapy within one week of surgery
- Patients with history of drug or alcohol abuse
- Patients who are allergic to lidocaine
- Contraindication to self administered morphine (unable to understand the PCA)
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 |
|---|---|---|
| Lidocaine InfusionInfusion of lidocaine 3mg/min or 2mg/min during surgery | Drug | Lidocaine Infusion |
| PlaceboSaline Infusion at same rate as experimental arm | Drug | Placebo |
Primary outcome
Verbal Rating Scale for pain with deep inspiration
Time frame: Up to 48 hrs post-initiation of patient-controlled analgesia
Patients will be questioned about pain intensities with a deep inspiratory breath using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, and 48 hours post-initiaition of patient-controlled analgesia.
PCA Morphine Consumption
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
Patient-controlled analgesia machines will be reviewed for the total morphine doses administered at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.
Number of PCA Morphine Requests
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
PCA machines will be reviewed for total number of PCA requests at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.
Verbal Rating Scale for pain at rest
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
Patients will be questioned about pain intensities at rest using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.
5 secondary outcomes
Nausea
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
Vomiting
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
Pruritus
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
Constipation
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
Urinary Retention
Time frame: Up to 48hrs post-initiation of patient-controlled analgesia
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 2 Dec 2014.
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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.
Dennis Ong, MD FRCPC principal investigator
University of Saskatchewan, Department of Anesthesiology, Perioperative Medicine, and Pain Management
Brian Taylor, MD study director
Department of Anesthesiology, Perioperative Medicine, and Pain Management
Ashraf Salem, MD study director
Department of Anesthesiology, Perioperative Medicine, and Pain Management
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 Infusion in people with Pain, run by University of Saskatchewan 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 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: finished, as of the sponsor's last update on 2 Dec 2014. 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?
Verbal Rating Scale for pain with deep inspiration (time frame: Up to 48 hrs post-initiation of patient-controlled analgesia). The study lists 4 primary outcomes in all. 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 2 Dec 2014.