Loading clinical trials...
Loading clinical trials...
Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
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.
Age
18 - 75 years
Sex
FEMALE
Healthy Volunteers
No
Juravinski Hospital
Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Start Date
November 1, 2014
Primary Completion Date
January 1, 2016
Completion Date
January 1, 2016
Last Updated
April 24, 2018
100
ACTUAL participants
Intraoperative Intravenous Lidocaine Infusion
DRUG
Perioperative Pregabalin
DRUG
Perioperative Pregabalin Placebo
DRUG
Intraoperative Intravenous Lidocaine Placebo Infusion
DRUG
Lead Sponsor
McMaster University
Collaborators
NCT06849466
NCT06606067
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06900842