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Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

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ClinicalTrials.gov Identifier: NCT00785382
Recruitment Status : Completed
First Posted : November 5, 2008
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Ronald George, IWK Health Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Postoperative Pain Drug: Placebo Drug: Pregabalin 150 mg Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo Controlled Trial of Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Pregabalin

Arm Intervention/treatment
Placebo Comparator: 1 Drug: Placebo
Lactulose Placebo

Experimental: 2 Drug: Pregabalin 150 mg
150 mg Q12H x 2 doses
Other Name: Lyrica




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. NRS / QoR - 48 hour Opioid Consumption Side effects - nausea, sedation [ Time Frame: 48 hours ]


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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Known or suspected allergy, sensitivity, or contraindication to pregabalin
  2. Known or suspected allergy to morphine, NSAIDs, acetaminophen or oxycodone
  3. Morbid Obesity (Body Mass Index ≥ 45 kg/m2)
  4. History of a seizure disorder
  5. Pregnancy
  6. Current pre-operative therapy with pregabalin, gabapentin, or any opioid
  7. Any other physical or psychiatric condition which may impair their ability to cooperate with postoperative study data collection
  8. CrCl < 60 ml/min [CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00785382


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

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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
First Posted: November 5, 2008    Key Record Dates
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by Ronald George, IWK Health Centre:
Pain, Pregabalin, Lyrica, Breast surgery

Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs