1602 Participants Needed

Lidocaine for Postoperative Pain in Breast Cancer

Recruiting at 18 trial locations
JK
NA
Overseen ByNour Ayach
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University Health Network, Toronto
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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

JK

James Khan, MD

Principal Investigator

University Health Network, Toronto

PD

PJ Devereaux, MD.PhD

Principal Investigator

Population Health Research Institute

IG

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

I am having a lumpectomy or mastectomy, for any reason including prevention.

Exclusion Criteria

I had breast surgery less than 6 months ago.
I am having surgery using my own tissue for reconstruction.
I have had chronic pain in the area of my upcoming surgery or nearby areas in the last 3 months.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intraoperative intravenous lidocaine infusion or placebo during breast cancer surgery

During surgery
1 visit (in-person)

Immediate Postoperative Follow-up

Participants are monitored for pain, analgesic consumption, and recovery in the first 3 days after surgery

3 days
Daily follow-up (in-person or virtual)

Follow-up

Participants are monitored for persistent pain, functional outcomes, and quality of life at 3 and 12 months postoperatively

12 months
2 visits (in-person or virtual)

Treatment Details

Interventions

  • Lidocaine 20mg/ml
  • Placebo
Trial Overview The PLAN trial is testing whether giving an IV infusion of Lidocaine during breast cancer surgery can prevent long-term pain after the operation. Participants will be randomly assigned to receive either Lidocaine or a placebo in a blinded setup.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Intraoperative intravenous lidocaine/placebo infusion
Group II: ControlPlacebo Group1 Intervention
Intraoperative intravenous lidocaine/placebo infusion

Lidocaine 20mg/ml is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Xylocaine for:
  • 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
🇪🇺
Approved in European Union as Lidocaine for:
  • Local anesthesia
  • Regional anesthesia
  • Pain relief in various medical procedures
🇨🇦
Approved in Canada as Lidocaine for:
  • 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

Trials
1,555
Recruited
526,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Findings from Research

A pilot study involving 150 patients undergoing breast cancer surgery demonstrated that peri-operative lidocaine infusion is safe, with in-hospital safety events occurring in only 3% of the lidocaine group compared to 1% in the placebo group.
The study showed that lidocaine levels during infusion were consistent with previous research, and while the adjusted odds ratio for postoperative pain at 6 months was 0.790, indicating a potential benefit, further large-scale trials are planned to confirm these findings.
A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery.Toner, AJ., Bailey, MA., Schug, SA., et al.[2021]
In a study of 148 women undergoing breast cancer surgery, intravenous lidocaine significantly reduced the incidence of reported postsurgical pain at 6 months compared to saline, with 13% of lidocaine patients reporting pain versus 29% in the saline group (P = 0.04).
Despite the reduction in reported pain incidence, only a small number of patients in both groups met the criteria for persistent postoperative pain, indicating that while lidocaine may help with pain management, it does not fully prevent chronic pain outcomes.
The Effect of Intraoperative Systemic Lidocaine on Postoperative Persistent Pain Using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Criteria Assessment Following Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial.Kendall, MC., McCarthy, RJ., Panaro, S., et al.[2019]
Intravenous lidocaine significantly reduced the incidence of persistent postsurgical pain (PPSP) in breast cancer surgery patients, with only 11.8% experiencing PPSP compared to 47.4% in the control group after three months.
Lidocaine also decreased the severity of pain and secondary hyperalgesia, suggesting that it may prevent central hyperalgesia, which is a potential mechanism for its effectiveness in managing postoperative pain.
Perioperative intravenous lidocaine decreases the incidence of persistent pain after breast surgery.Grigoras, A., Lee, P., Sattar, F., et al.[2022]

References

A pilot multicentre randomised controlled trial of lidocaine infusion in women undergoing breast cancer surgery. [2021]
The Effect of Intraoperative Systemic Lidocaine on Postoperative Persistent Pain Using Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials Criteria Assessment Following Breast Cancer Surgery: A Randomized, Double-Blind, Placebo-Controlled Trial. [2019]
Perioperative intravenous lidocaine decreases the incidence of persistent pain after breast surgery. [2022]
Lidocaine 5 % patches as an effective short-term co-analgesic in cancer pain. Preliminary results. [2021]
Effect of intravenous lidocaine on chronic postoperative pain in patients undergoing breast cancer surgery: a prospective, double-blind, randomized, placebo-controlled clinical trial. [2022]
[Treatment of persistent postmastectomy pain with 5% Lidocaine medicated plaster]. [2015]
[Efficacy and safety of lidocaine hydrochloride jelly for the treatment of pain caused by breast cancer metastases to the skin]. [2013]
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