Status:
COMPLETED
Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Hamilton Health Sciences Corporation
Conditions:
Post-mastectomy Pain Syndrome
Chronic Post-surgical Pain
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
Breast tissue and the areas surrounding the breast contain many small to medium-sized nerves. During surgery on the breast, these nerves can be inadvertently cut or damaged. Chemotherapy and radiother...
Eligibility Criteria
Inclusion
- female patients 18-75 years of age
- undergoing a unilateral or bilateral mastectomy or partial-mastectomy (breast conserving surgery), for prophylactic (e.g. family history or BRCA gene mutation) or belief of isolated (non-metastatic) cancerous lesions
- receiving a general anesthetic
Exclusion
- previous breast surgery within six months of index surgery
- undergoing a DIEP (Deep Inferior Epigastric Perforator) flap procedure
- patient has chronic pain or a chronic pain syndrome for which they have taken 4 or more daily medications (i.e. opioids, anti-convulsants, anti-spasmodic, anti-depressants, anti-inflammatories) or routine pain intervention (i.e. nerve blocks) during the past 3 months
- documented hypersensitivity or allergy to pregabalin, gabapentin, or lidocaine
- history of ventricular tachycardia, ventricular fibrillation, or atrioventricular block ≥ type II
- history of congestive heart failure
- renal insufficiency with creatinine \> 120 µmol/L
- known or previously documented cirrhosis
- pregnant
- unable to swallow study medications
- patient's surgeon believes patient is inappropriate for inclusion in trial
- unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town)
- language difficulties that would impede valid completion of questionnaires
- patient requires gabapentin or pregabalin for a medical condition or has been taking gabapentin or pregabalin daily during the past 1 week
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02240199
Start Date
November 1 2014
End Date
January 1 2016
Last Update
April 24 2018
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Juravinski Hospital
Hamilton, Ontario, Canada, L8V 1C3
2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5