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| Name | Class |
|---|---|
| Hamilton Health Sciences Corporation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin/Lidocaine | Experimental | Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion |
|
| Pregabalin Placebo/Lidocaine | Active Comparator | Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion |
|
| Pregabalin/Lidocaine Placebo | Active Comparator | Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion |
|
| Pregabalin Placebo/Lidocaine Placebo | Placebo Comparator | Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-mastectomy pain syndrome | 6 months | |
| Length of hospital stay | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James S Khan, BHSc, MD | Population Health Research Institute | Study Director |
| P.J. Devereaux, MD, PhD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Juravinski Hospital | Hamilton | Ontario | L8V 1C3 | Canada | ||
| Sunnybrook Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30844507 | Derived | 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. |
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|
| 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. |
|
|
| 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. |
|
| 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 |
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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