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

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?

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)))]

Treatment and study plan

Pregabalin

Drug

pregabalin 75 or 150 mg

Placebo

Drug

lactulose placebo

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

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Oct 28, 2008
Registry last updated: May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed