Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

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 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.

Conditions

• Post-mastectomy Pain Syndrome
• Chronic Post-surgical Pain

Interventions

DRUG

Intraoperative Intravenous Lidocaine Infusion

Lidocaine 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.

DRUG

Perioperative Pregabalin

Pregabalin 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.

DRUG

Perioperative Pregabalin Placebo

Pregabalin placebo 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.

DRUG

Intraoperative Intravenous Lidocaine Placebo Infusion

Lidocaine placebo 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation

  collaborator OTHER

• McMaster University

  lead OTHER

Principal Investigators

• James S Khan, BHSc, MD · Population Health Research Institute

• P.J. Devereaux, MD, PhD · Population Health Research Institute

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-11-30

Primary Completion

2016-01-31

Completion

2016-01-31

Countries

• Canada

Study Locations