Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Information source: IWK Health Centre
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Pain
Intervention: Placebo (Drug); Pregabalin 150 mg (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: IWK Health Centre Official(s) and/or principal investigator(s):
Ronald B George, MD FRCPC, Principal Investigator, Affiliation: IWK
Overall contact:
Ronald B George, MD FRCPC, Phone: 902 470-6627, Email: rbgeorge@dal.ca
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?
Clinical Details
Official title: A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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: NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation
Eligibility
Minimum age: N/A.
Maximum age: 65 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. American Society of Anesthesia physical status class I & II
2. Age ¬< 65 years
3. English-speaking
4. Unilateral breast cancer surgery without axillary node dissection (i. e. simple
mastectomies and lumpectomies +/- "sentinal" node biopsy)
Exclusion Criteria:
1. Known or suspected allergy, sensitivity, or contraindication to pregabalin
2. Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
3. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
4. History of a seizure disorder
5. Pregnancy
6. Current pre-operative therapy with pregabalin, gabapentin, or any opioid
7. Any other physical or psychiatric condition which may impair their ability to
cooperate with postoperative study data collection
8. CrCl < 60 ml/min [CrCl = 0. 85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]
Locations and Contacts
Ronald B George, MD FRCPC, Phone: 902 470-6627, Email: rbgeorge@dal.ca
IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada; Recruiting
Ronald George, MD FRCPC, Phone: 902 470-6627, Email: rbgeorge@dal.ca
Dolores McKeen, MD MSc FRCPC, Phone: 902 470-6627, Email: dolores.mckeen@iwk.nshealth.ca
Ronald B George, MD FRCPC, Principal Investigator
Dolores McKeen, MD MSc FRCPC, Sub-Investigator
Additional Information
Starting date: January 2009
Last updated: August 7, 2009
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