Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

Phase 3

Completed

• Conditions: Post-mastectomy Pain Syndrome; Chronic Post-surgical Pain
• Interventions: Drug: Intraoperative Intravenous Lidocaine Infusion; Drug: Perioperative Pregabalin Placebo; Drug: Perioperative Pregabalin; Drug: Intraoperative Intravenous Lidocaine Placebo Infusion

• Registration Number: NCT02240199
• Lead Sponsor: McMaster University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Study Start: 2014-11
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-12
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Pregabalin Placebo/Lidocaine	Perioperative Pregabalin Placebo	Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion
Pregabalin Placebo/Lidocaine	Intraoperative Intravenous Lidocaine Infusion	Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion
Pregabalin/Lidocaine	Intraoperative Intravenous Lidocaine Infusion	Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion
Pregabalin/Lidocaine	Perioperative Pregabalin	Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion
Pregabalin Placebo/Lidocaine Placebo	Perioperative Pregabalin Placebo	Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
Pregabalin/Lidocaine Placebo	Perioperative Pregabalin	Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion
Pregabalin Placebo/Lidocaine Placebo	Intraoperative Intravenous Lidocaine Placebo Infusion	Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
Pregabalin/Lidocaine Placebo	Intraoperative Intravenous Lidocaine Placebo Infusion	Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion

Primary Outcome Measures

Name	Time	Method
Feasibility	6 months	The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.

Secondary Outcome Measures

Name	Time	Method
Post-mastectomy pain syndrome	6 months
Length of hospital stay	Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.	Most breast cancer surgeries are day procedures, therefore length of hospital stay will be measured based on whether or not the patient was discharged from the hospital on the same day as surgery or if they were admitted and remained in hospital overnight.
Quality of Life	3 months
Somatic Pre-occupation and Coping Scale	3 months
Acute postoperative pain	Postoperative days 1-9

Trial Locations

Locations (2)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada

Juravinski Hospital; 🇨🇦 Hamilton, Ontario, Canada