Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery - Full Text View

Sponsor:	IWK Health Centre
Information provided by (Responsible Party):	Ronald George, IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00785382

Purpose

We hypothesize that pregabalin will decrease postoperative pain, as measured by the surrogate markers postoperative pain rating scores and postoperative opioid consumption while improving the quality of recovery following breast cancer surgery compared to placebo. The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. Do women undergoing breast cancer surgery with general anesthesia and receiving pregabalin prior to their surgery and 12 hours later have lower NRS and a greater QoR score in the first 24 hours after their surgery than those women who received placebo?

Condition	Intervention	Phase
Postoperative Pain	Drug: Placebo Drug: Pregabalin 150 mg	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 Postoperative Pain in Women Undergoing Breast Cancer Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Pregabalin

U.S. FDA Resources

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:

The primary outcome will be postoperative pain, measured by a NRS and the quality of recovery score (QoR) in the first 24h postoperative period. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	January 2009
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1	Drug: Placebo Lactulose Placebo
Experimental: 2	Drug: Pregabalin 150 mg 150 mg Q12H x 2 doses Other Name: Lyrica

Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

American Society of Anesthesia physical status class I & II
Age ¬< 65 years
English-speaking
Unilateral breast cancer surgery without axillary node dissection (i.e. simple mastectomies and lumpectomies +/- "sentinal" node biopsy)

Exclusion Criteria:

Known or suspected allergy, sensitivity, or contraindication to pregabalin
Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
History of a seizure disorder
Pregnancy
Current pre-operative therapy with pregabalin, gabapentin, or any opioid
Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative 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: NCT00785382

Contacts

Contact: Ronald B George, MD FRCPC	902 470-6627	rbgeorge@dal.ca
Contact: Dolores McKeen, MD MSc FRCPC	902 470-6627	dolores.mckeen@iwk.nshealth.ca

Locations

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

Sponsors and Collaborators

IWK Health Centre

Investigators

Principal Investigator:

Ronald B George, MD FRCPC

IWK

More Information

No publications provided

Responsible Party:	Ronald George, Primary Investigator, MD, FRCPC, Assistant Professor, IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00785382 History of Changes
Other Study ID Numbers:	IWK-4298-2008
Study First Received:	November 4, 2008
Last Updated:	November 1, 2011
Health Authority:	Canada: Health Canada

Keywords provided by IWK Health Centre:

Pain, Pregabalin, Lyrica, Breast surgery

Additional relevant MeSH terms:

Breast Neoplasms
Pain, Postoperative
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Pregabalin
Gamma-Aminobutyric Acid

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012