NCT02240199|CompletedPhase 3
Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
PLAN
Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
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PLAN
Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
Sponsor study identifier
interventional
100
1 country
2
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 19, 2014
Actual (reported)September 15, 2014
Actual (reported)November 2014
Date type not reportedThis date has not been verified as actual or estimated.
January 2016
Actual (reported)January 2016
Actual (reported)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
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
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion
Perioperative Pregabalin Placebo, 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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Perioperative Pregabalin Placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordControl intervention
Intraoperative Intravenous Lidocaine Placebo Infusion
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordJuravinski Hospital
Hamilton, Ontario, L8V 1C3, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
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.
James S Khan, BHSc, MD
Population Health Research Institute
P.J. Devereaux, MD, PhD
Population Health Research Institute
100 participants (actual enrollment reported by the registry).
First Submitted
August 19, 2014
First Posted
September 15, 2014
Study Start
November 2014
Date type not reportedThis date has not been verified as actual or estimated.
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion
Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
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.
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.
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.
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Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
April 24, 2018
Record last verified: 2016-12
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Source: ClinicalTrials.gov.
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