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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781131
• Other study ID #: IWK-4101-2007
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: May 22, 2013
• Start date: May 2008
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)))]

Study Design

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

Related Conditions & MeSH terms

• Opioid Use
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Pregabalin
pregabalin 75 or 150 mg
• Placebo
lactulose placebo

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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?		1 year	Yes