PLAN: Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pregabalin/Lidocaine Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion |
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.
Other Names:
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.
Other Names:
|
| Active Comparator: Pregabalin Placebo/Lidocaine Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion |
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.
Other Names:
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.
|
| Active Comparator: Pregabalin/Lidocaine Placebo Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion |
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.
Other Names:
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.
|
| Placebo Comparator: Pregabalin Placebo/Lidocaine Placebo Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion |
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Juravinski Hospital | Hamilton | Ontario | Canada | L8V 1C3 |
| 2 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
Sponsors and Collaborators
- McMaster University
- Hamilton Health Sciences Corporation
Investigators
- Study Director: James S Khan, BHSc, MD, Population Health Research Institute
- Principal Investigator: P.J. Devereaux, MD, PhD, Population Health Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PLAN14001