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NCT Number: NCT02240199

Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

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.

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Key information

Conditions

Post-mastectomy Pain Syndrome Chronic Post-surgical Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Juravinski Hospital, Hamilton, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative Intravenous Lidocaine Infusion

Drug

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: Xylocaine

Perioperative Pregabalin

Drug

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: Lyrica

Perioperative Pregabalin Placebo

Drug

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

Drug

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.

Primary outcomes

  1. Feasibility

    Time frame: 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 outcomes

  1. Post-mastectomy pain syndrome

    Time frame: 6 months

  2. Length of hospital stay

    Time frame: 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.

  3. Quality of Life

    Time frame: 3 months

  4. Somatic Pre-occupation and Coping Scale

    Time frame: 3 months

  5. Acute postoperative pain

    Time frame: Postoperative days 1-9

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation

Registry information

Official study title

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

Acronym: PLAN

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 15, 2014
Registry last updated
Apr 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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