Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 100
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
1,602 (estimated)
Sponsor
University Health Network, Toronto · Other
Who this trial is looking for
This trial is looking for adults who are having breast cancer surgery. Participants will receive a medication during surgery to see if it helps reduce pain after their operation.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old
I am scheduled for breast surgery, either a lumpectomy or mastectomy
You may not be able to join if
I had breast surgery in the last 6 months
I am undergoing a special type of surgery called an autologous flap procedure
I have had chronic pain in the area of surgery in the past 3 months
I am allergic to lidocaine
My surgery is not going to be done under general anesthesia
I have a history of serious heart problems without a pacemaker
I have cirrhotic liver disease
I am pregnant
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. Age ≥18 years old
2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Exclusion Criteria:
1. Previous breast surgery within 6 months of index surgery
2. U…
Inclusion Criteria:
1. Age ≥18 years old
2. Undergoing a unilateral or bilateral lumpectomy or mastectomy, inclusive of all pathologies, including prophylactic surgery (e.g., family history or BRCA gene mutation)
Exclusion Criteria:
1. Previous breast surgery within 6 months of index surgery
2. Undergoing any autologous flap procedure during index surgery
3. Presence known chronic pain disorder involving surgical site or ipsilateral chest wall, shoulder, or arm during the 3-months prior to index surgery
4. Documented hypersensitivity or allergy to lidocaine
5. Surgery not planned to be performed under general anesthesia and/or planned use of regional or neuraxial anesthetic techniques before surgery (i.e., epidural, paravertebral, serratus plane block, pectoralis or modified pectoralis block)
6. History of ventricular tachycardia, ventricular fibrillation, or atrioventricular block without a pacemaker
7. Known cirrhotic liver disease
8. Pregnant
9. Unlikely to comply with follow-up (e.g. no fixed address, language difficulties that would impede valid completion of questionnaires, plans to move out of town)
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
