Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

NCT02240199 | Completed Phase 3

• 1 other identifier: PLAN14001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-mastectomy Pain Syndrome; Chronic Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

• Quality of Life

  3 months

• Somatic Pre-occupation and Coping Scale

  3 months

• Acute postoperative pain

  Postoperative days 1-9

Study Arms (4)

Pregabalin/Lidocaine

EXPERIMENTAL

Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion

Drug: Intraoperative Intravenous Lidocaine Infusion; Drug: Perioperative Pregabalin

Pregabalin Placebo/Lidocaine

ACTIVE COMPARATOR

Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion

Drug: Intraoperative Intravenous Lidocaine Infusion; Drug: Perioperative Pregabalin Placebo

Pregabalin/Lidocaine Placebo

ACTIVE COMPARATOR

Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion

Drug: Perioperative Pregabalin; Drug: Intraoperative Intravenous Lidocaine Placebo Infusion

Pregabalin Placebo/Lidocaine Placebo

PLACEBO COMPARATOR

Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion

Drug: Perioperative Pregabalin Placebo; Drug: Intraoperative Intravenous Lidocaine Placebo Infusion

Interventions

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.

Also known as: Xylocaine

Pregabalin Placebo/Lidocaine; Pregabalin/Lidocaine

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.

Also known as: Lyrica

Pregabalin/Lidocaine; Pregabalin/Lidocaine Placebo

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.

Pregabalin Placebo/Lidocaine; Pregabalin Placebo/Lidocaine Placebo

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.

Pregabalin Placebo/Lidocaine Placebo; Pregabalin/Lidocaine Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator

Study Sites (2)

Juravinski Hospital

Hamilton, Ontario, L8V 1C3, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Related Publications (1)

• 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.

  PMID: 30844507 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Pregabalin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• James S Khan, BHSc, MD

  Population Health Research Institute

  STUDY DIRECTOR

• P.J. Devereaux, MD, PhD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: September 15, 2014
• Study Start: November 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: April 24, 2018

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)