Back to resultsPregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Placebo
Pregabalin 150 mg
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, Pregabalin, Lyrica, Breast surgery
Eligibility Criteria
Inclusion Criteria:
- American Society of Anesthesia physical status class I & II
- Age ¬< 65 years
- English-speaking
- Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)
Exclusion Criteria:
- Known or suspected allergy, sensitivity, or contraindication to pregabalin
- Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
- Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- History of a seizure disorder
- Pregnancy
- Current pre-operative therapy with pregabalin, gabapentin, or any opioid
- Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
- CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
Sites / Locations
- IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
Secondary Outcome Measures
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00785382
Brief Title
Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Official Title
A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IWK Health Centre
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Pain, Pregabalin, Lyrica, Breast surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Lactulose Placebo
Intervention Type
Drug
Intervention Name(s)
Pregabalin 150 mg
Other Intervention Name(s)
Lyrica
Intervention Description
150 mg Q12H x 2 doses
Primary Outcome Measure Information:
Title
The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Time Frame
48 hours
10. Eligibility
Sex
Female
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesia physical status class I & II
Age ¬< 65 years
English-speaking
Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)
Exclusion Criteria:
Known or suspected allergy, sensitivity, or contraindication to pregabalin
Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
History of a seizure disorder
Pregnancy
Current pre-operative therapy with pregabalin, gabapentin, or any opioid
Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B George, MD FRCPC
Organizational Affiliation
IWK
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
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