A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy
Overview
- Phase
- Phase 4
- Intervention
- Placebo
- Conditions
- Postoperative Pain
- Sponsor
- IWK Health Centre
- Enrollment
- 101
- Locations
- 1
- Primary Endpoint
- Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
We hypothesize that pregabalin will decrease post-operative pain scores and opioid use following abdominal hysterectomy compared to placebo. This study has been designed to determine if after an abdominal hysterectomy, the addition of pregabalin to their peri-operative analgesia regimen will demonstrate superior analgesia compared to placebo in terms of lower pain scores and reduced usage of opioids. The primary outcome will be post-operative pain, measured by total opioid consumption.
Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption 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 \> 18 years
- •English-speaking
- •Capability to operate a patient-controlled analgesia (PCA) device
Exclusion Criteria
- •Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents)
- •Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
- •History of a seizure disorder
- •Current therapy with pregabalin, gabapentin, or any opioid
- •Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative 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
Pregabalin 75 mg
Intervention: Pregabalin
3
Pregabalin 150 mg
Intervention: Pregabalin
Outcomes
Primary Outcomes
Do women undergoing an abdominal hysterectomy with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower opioid consumption in the first 24 hours after their surgery than those women who received placebo?
Time Frame: 1 year