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Pregabalin for Postoperative Pain in Women Undergoing Breast Cancer Surgery

NCT ID: NCT00785382

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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?

Detailed Description

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Conditions

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Postoperative Pain

Keywords

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Pain, Pregabalin, Lyrica, Breast surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Lactulose Placebo

2

Group Type EXPERIMENTAL

Pregabalin 150 mg

Intervention Type DRUG

150 mg Q12H x 2 doses

Interventions

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Placebo

Lactulose Placebo

Intervention Type DRUG

Pregabalin 150 mg

150 mg Q12H x 2 doses

Intervention Type DRUG

Other Intervention Names

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Lyrica

Eligibility Criteria

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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 \[CrCl = 0.85 x ((140 - age) x weight(kg)) / (72 x Cr(mg/dL)))\]
Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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Ronald George

Primary Investigator, MD, FRCPC, Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald B George, MD FRCPC

Role: PRINCIPAL_INVESTIGATOR

IWK

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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IWK-4298-2008

Identifier Type: -

Identifier Source: org_study_id