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

Sponsor:	IWK Health Centre
Information provided by (Responsible Party):	Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00781131

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 IV

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:

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)))]

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 February 09, 2012