Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain (PLAN)

McMaster University

Status and phase: Completed; Phase 3

Conditions: Chronic Post-surgical Pain; Post-mastectomy Pain Syndrome

Treatments: Drug: Perioperative Pregabalin; Drug: Perioperative Pregabalin Placebo; Drug: Intraoperative Intravenous Lidocaine Placebo Infusion; Drug: Intraoperative Intravenous Lidocaine Infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT02240199

PLAN14001

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

Pregabalin/Lidocaine

Experimental group

Description:

Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion

Treatment:

Drug: Intraoperative Intravenous Lidocaine Infusion

Drug: Perioperative Pregabalin

Pregabalin Placebo/Lidocaine

Active Comparator group

Description:

Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion

Treatment:

Drug: Intraoperative Intravenous Lidocaine Infusion

Drug: Perioperative Pregabalin Placebo

Pregabalin/Lidocaine Placebo

Active Comparator group

Description:

Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion

Treatment:

Drug: Intraoperative Intravenous Lidocaine Placebo Infusion

Drug: Perioperative Pregabalin

Pregabalin Placebo/Lidocaine Placebo

Placebo Comparator group

Description:

Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion

Treatment:

Drug: Intraoperative Intravenous Lidocaine Placebo Infusion

Drug: Perioperative Pregabalin Placebo