A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Postoperative Pain
- Sponsor
- IWK Health Centre
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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?
Investigators
Ronald George
Primary Investigator, MD, FRCPC, Assistant Professor
IWK Health Centre
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
- •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 \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]
Arms & Interventions
1
Intervention: Placebo
2
Intervention: Pregabalin 150 mg
Outcomes
Primary Outcomes
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 Outcomes
- NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation(48 hours)