Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

IWK Health Centre101 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

101

Conditions

Postoperative Pain Opioid Use

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. American Society of Anesthesia physical status class I \& II 2. Age \> 18 years 3. English-speaking 4. Capability to operate a patient-controlled analgesia (PCA) device Exclusion Criteria: 1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications (i.e. morphine, anesthetic agents) 2. Morbid Obesity (Body Mass Index ≥ 45 kg/m2) 3. History of a seizure disorder 4. Current therapy with pregabalin, gabapentin, or any opioid 5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection 6. CrCl \< 60 ml/min \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]

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