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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00781131
First received: October 27, 2008
Last updated: November 1, 2011
Last verified: November 2011
History of Changes
  Purpose

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?


Condition Intervention Phase
Postoperative Pain
Opioid Use
 Drug: Pregabalin
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled Trial of Pregabalin for Post-operative Pain in Women Undergoing Abdominal Hysterectomy

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
Drug Information available for: Pregabalin
U.S. FDA Resources

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 90
Study Start Date: May 2008
Study Completion Date: January 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: Placebo
lactulose placebo
Experimental: 2
Pregabalin 75 mg
 Drug: Pregabalin
pregabalin 75 or 150 mg
Experimental: 3
Pregabalin 150 mg
 Drug: Pregabalin
pregabalin 75 or 150 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)))]
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781131

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Investigators
Principal Investigator: Ronald B George, MD FRCPC IWK Health Centre
  More Information

No publications provided

Responsible Party: Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00781131     History of Changes
Other Study ID Numbers: IWK-4101-2007
Study First Received: October 27, 2008
Last Updated: November 1, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants

ClinicalTrials.gov processed this record on May 16, 2013