Lidocaine for Postoperative Pain in Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug lidocaine for reducing postoperative pain in breast cancer surgery?
Research shows that using lidocaine during and after breast cancer surgery can reduce the chances of long-term pain. Studies found that patients receiving lidocaine had fewer pain issues compared to those who received a placebo, indicating its potential effectiveness in managing postoperative pain.12345
Is lidocaine safe for use in humans, particularly for postoperative pain in breast cancer surgery?
Research shows that lidocaine is generally safe for use in humans, with rare in-hospital safety events reported in trials. Serum levels of lidocaine during treatment were within safe ranges, and no undesirable effects were observed in studies using lidocaine for pain management in breast cancer patients.12467
How does the drug lidocaine differ from other treatments for postoperative pain in breast cancer surgery?
Lidocaine is unique because it is used as an intravenous infusion during and after breast cancer surgery to potentially prevent chronic postoperative pain, which is a common issue. This approach is different from standard pain management as it focuses on reducing long-term pain development rather than just addressing immediate postoperative pain.13457
What is the purpose of this trial?
Phase III, international multicentre, parallel group, blinded, 1:1 randomized controlled trial to determine the effect of an intraoperative intravenous lidocaine infusion on reducing the development of persistent pain 3-months after breast cancer surgery.
Research Team
James Khan, MD
Principal Investigator
University Health Network, Toronto
PJ Devereaux, MD.PhD
Principal Investigator
Population Health Research Institute
Ian Gilron, MD
Principal Investigator
Kingston Health Sciences Centre
Eligibility Criteria
This trial is for adults over 18 who are having breast cancer surgery (lumpectomy or mastectomy) for any reason, including high risk without current cancer. It's not for those with recent breast surgery, chronic pain at the site, lidocaine allergy, certain heart conditions, liver disease, pregnancy or if they can't follow up.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive an intraoperative intravenous lidocaine infusion or placebo during breast cancer surgery
Immediate Postoperative Follow-up
Participants are monitored for pain, analgesic consumption, and recovery in the first 3 days after surgery
Follow-up
Participants are monitored for persistent pain, functional outcomes, and quality of life at 3 and 12 months postoperatively
Treatment Details
Interventions
- Lidocaine 20mg/ml
- Placebo
Lidocaine 20mg/ml is already approved in United States, European Union, Canada for the following indications:
- Prevention and control of pain in procedures involving the male and female urethra
- Topical treatment of painful urethritis
- Anesthetic lubricant for endotracheal intubation (oral and nasal)
- Production of local or regional anesthesia by infiltration techniques
- Percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques
- Local anesthesia
- Regional anesthesia
- Pain relief in various medical procedures
- Local anesthesia
- Regional anesthesia
- Pain relief in various medical procedures
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator