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

Sponsored by:	IWK Health Centre
Information provided by:	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

MedlinePlus related topics: Anesthesia Hysterectomy Surgery

Drug Information available for: Pregabalin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized, Placebo Controlled Trial of Pregabalin for Post-Operative Pain in Women Undergoing Abdominal Hysterectomy

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
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo lactulose placebo
2: Experimental Pregabalin 75 mg	Drug: Pregabalin pregabalin 75 or 150 mg
3: Experimental 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

Contacts

Contact: Ronald B George, MD FRCPC	(902) 470-7059	rbgeorge@dal.ca
Contact: Ronald George	(902) 470-7059	rbgeorge@dal.ca

Locations

Canada, Nova Scotia
IWK Health Centre	Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Ronald B George, MD FRCPC (902) 470-6627 rbgeorge@dal.ca
Contact: Ronald George (902) 470-7059 rbgeorge@dal.ca
Sub-Investigator: Dolores McKeen, MD MSc FRCPC
Principal Investigator: Ronald B George, MD FRCPC

Sponsors and Collaborators

IWK Health Centre

Investigators

Principal Investigator:

Ronald B George, MD FRCPC

IWK Health Centre

More Information

No publications provided

Responsible Party:	Department of Women's & Obstetric Anesthesia ( Ronald B. George, MD FRCPC )
Study ID Numbers:	IWK-4101-2007
Study First Received:	October 27, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00781131 History of Changes
Health Authority:	Canada: Health Canada

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pregabalin
Pain
Peripheral Nervous System Agents

Analgesics
Anticonvulsants
Pain, Postoperative
Lactulose

Additional relevant MeSH terms:

Physiological Effects of Drugs
Pregabalin
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes
Postoperative Complications

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Pain, Postoperative

ClinicalTrials.gov processed this record on May 07, 2009