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Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain (PLAN)

Primary Purpose

Post-mastectomy Pain Syndrome, Chronic Post-surgical Pain

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Intraoperative Intravenous Lidocaine Infusion
Perioperative Pregabalin
Perioperative Pregabalin Placebo
Intraoperative Intravenous Lidocaine Placebo Infusion
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post-mastectomy Pain Syndrome

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Juravinski Hospital
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Pregabalin/Lidocaine

Pregabalin Placebo/Lidocaine

Pregabalin/Lidocaine Placebo

Pregabalin Placebo/Lidocaine Placebo

Arm Description

Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion

Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion

Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion

Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Post-mastectomy pain syndrome
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.
Quality of Life
Somatic Pre-occupation and Coping Scale
Acute postoperative pain

Full Information

First Posted
August 19, 2014
Last Updated
April 20, 2018
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02240199
Brief Title
Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain
Acronym
PLAN
Official Title
Pregabalin and Lidocaine in Breast Cancer Surgery to Alter Neuropathic Pain (PLAN): A Pilot Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-mastectomy Pain Syndrome, Chronic Post-surgical Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin/Lidocaine
Arm Type
Experimental
Arm Description
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Infusion
Arm Title
Pregabalin Placebo/Lidocaine
Arm Type
Active Comparator
Arm Description
Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Infusion
Arm Title
Pregabalin/Lidocaine Placebo
Arm Type
Active Comparator
Arm Description
Perioperative Pregabalin, Intraoperative Intravenous Lidocaine Placebo Infusion
Arm Title
Pregabalin Placebo/Lidocaine Placebo
Arm Type
Placebo Comparator
Arm Description
Perioperative Pregabalin Placebo, Intraoperative Intravenous Lidocaine Placebo Infusion
Intervention Type
Drug
Intervention Name(s)
Intraoperative Intravenous Lidocaine Infusion
Other Intervention Name(s)
Xylocaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Perioperative Pregabalin
Other Intervention Name(s)
Lyrica
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Perioperative Pregabalin Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Intraoperative Intravenous Lidocaine Placebo Infusion
Intervention Description
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 Outcome Measure Information:
Title
Feasibility
Description
The feasibility outcome will be measured by the rate of recruitment, compliance, percentage of patient's with complete follow-up and site resource requirements.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Post-mastectomy pain syndrome
Time Frame
6 months
Title
Length of hospital stay
Description
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.
Time Frame
Total number of overnight stays spent in hospital continuously from the day of surgery until a maximum of 3 months post-operatively.
Title
Quality of Life
Time Frame
3 months
Title
Somatic Pre-occupation and Coping Scale
Time Frame
3 months
Title
Acute postoperative pain
Time Frame
Postoperative days 1-9

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James S Khan, BHSc, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
P.J. Devereaux, MD, PhD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juravinski Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30844507
Citation
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.
Results Reference
derived

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Perioperative Pregabalin and Lidocaine to Reduce Chronic Breast Cancer Pain

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