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A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery


Phase 4
N/A
65 Years
Not Enrolling
Female
Postoperative Pain

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Trial Information

A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery


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)))]

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.

Outcome Time Frame:

24 hours

Safety Issue:

No

Principal Investigator

Ronald B George, MD FRCPC

Investigator Role:

Principal Investigator

Investigator Affiliation:

IWK

Authority:

Canada: Health Canada

Study ID:

IWK-4298-2008

NCT ID:

NCT00785382

Start Date:

January 2009

Completion Date:

December 2011

Related Keywords:

  • Postoperative Pain
  • Pain, Pregabalin, Lyrica, Breast surgery
  • Breast Neoplasms
  • Pain, Postoperative

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