Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

Post-mastectomy Pain Syndrome Clinical Trial

— PLAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02240199
• Other study ID #: PLAN14001
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2014
• Last updated: April 20, 2018
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.	6 months
Secondary	Post-mastectomy pain syndrome		6 months
Secondary	Length of hospital stay	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.	Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.
Secondary	Quality of Life		3 months
Secondary	Somatic Pre-occupation and Coping Scale		3 months
Secondary	Acute postoperative pain		Postoperative days 1-9