Clinical trial NCT02240199: Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
Official title: Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-mastectomy Pain Syndrome
Chronic Post-surgical Pain
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
First posted: 2014-09-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.


Eligibility 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
* 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

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
Secondary outcomes:
measure: Post-mastectomy pain syndrome
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.
measure: Quality of Life
timeFrame: 3 months
measure: Somatic Pre-occupation and Coping Scale
timeFrame: 3 months
measure: Acute postoperative pain
timeFrame: Postoperative days 1-9
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Population Health Research Institute
name: James S Khan, BHSc, MD
role: STUDY_DIRECTOR
affiliation: Population Health Research Institute
name: P.J. Devereaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khan JS, Hodgson N, Choi S, Reid S, Paul JE, Hong NJL, Holloway C, Busse JW, Gilron I, Buckley DN, McGillion M, Clarke H, Katz J, Mackey S, Avram R, Pohl K, Rao-Melacini P, Devereaux PJ. Perioperative Pregabalin and Intraoperative Lidocaine Infusion to Reduce Persistent Neuropathic Pain After Breast Cancer Surgery: A Multicenter, Factorial, Randomized, Controlled Pilot Trial. J Pain. 2019 Aug;20(8):980-993. doi: 10.1016/j.jpain.2019.02.010. Epub 2019 Mar 5.