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Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

Information source: McMaster University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post-mastectomy Pain Syndrome; Chronic Post-surgical Pain

Intervention: Intraoperative Intravenous Lidocaine Infusion (Drug); Perioperative Pregabalin (Drug); Perioperative Pregabalin Placebo (Drug); Intraoperative Intravenous Lidocaine Placebo Infusion (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Hamilton Health Sciences Corporation

Official(s) and/or principal investigator(s):
James S Khan, BHSc, MD, Study Director, Affiliation: Population Health Research Institute
P.J. Devereaux, MD, PhD, Principal Investigator, Affiliation: Population Health Research Institute

Overall contact:
Kayla Pohl, BA, CCRP, Phone: 905-527-4322, Ext: 40694, Email: plan@phri.ca


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 radiotherapy after surgery worsen the injury experienced by these nerves. These nerves eventually become abnormal and provide pain signals to the brain well beyond the healing period after surgery. Patients with these abnormal nerves suffer from chronic pain in the breast area that persists for several years after surgery. Chronic pain is associated with a reduced quality of life, daily functioning, psychological distress, and contributes to excessive health care expenditures. There is encouraging data suggesting that an infusion of Lidocaine during surgery and Pregabalin given around the time of surgery can prevent the development of chronic pain after breast cancer surgery. A large randomized controlled trial is needed to determine the efficacy of these two interventions on reducing chronic pain after breast cancer surgery (e. g. within 3 months of surgery). A pilot trial is first needed to determine the feasibility of undertaking such a trial.

Clinical Details

Official title: Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Feasibility

Secondary outcome:

Post-mastectomy pain syndrome

Length of hospital stay

Quality of Life

Somatic Pre-occupation and Coping Scale

Acute postoperative pain


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Female.


Inclusion Criteria:

- 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 Criteria:

- 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

Locations and Contacts

Kayla Pohl, BA, CCRP, Phone: 905-527-4322, Ext: 40694, Email: plan@phri.ca

Juravinski Hospital, Hamilton, Ontario L8V 1C3, Canada; Recruiting
Krysten Gregus, RN, Phone: 905-521-2100, Ext: 67177, Email: gregus@hhsc.ca
Susan Reid, MD, Principal Investigator
James Paul, MSc, MD, Principal Investigator

Sunnybrook Health Sciences Centre, Toronto, Ontario M4N 3M5, Canada; Recruiting
Shelly Au, Phone: 416-480-6100, Ext: 89607, Email: shelly.au@sunnybrook.ca
Stephen Choi, MSc, MD, Principal Investigator

Additional Information

Starting date: November 2014
Last updated: July 14, 2015

Page last updated: August 23, 2015

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