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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00938548 |
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Date of registration:
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13/07/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Perioperative Administration of Pregabalin for Pain After Mastectomy
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Scientific title:
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Perioperative Administration of Pregabalin for Pain After Mastectomy |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00938548 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Korea, Republic of
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. American Society of Anesthesia physical status class I & II
2. Age > 20 and < 70 years
3. Robot- assisted endoscopic thyroidectomy
Exclusion Criteria:
1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of
the standardized medications
2. Body mass index = 40 kg/m2
3. History of seizure disorder
4. Current therapy with pregabalin, gabapentin, or any opioid
5. Any other physical or psychiatric condition which may impair their ability to
cooperate with post-operative study data collection
6. Insulin-dependent diabetes mellitus
7. Renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2)
Age minimum:
21 Years
Age maximum:
69 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pain, Postoperative
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Intervention(s)
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Drug: Pregabalin
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Drug: Vitamin Complex (placebo)
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Primary Outcome(s)
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Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
[Time Frame: 1, 6, 24, 48 hour]
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Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.
[Time Frame: 1, 6, 24, 48 hour]
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Secondary Outcome(s)
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Pain Scores (VNRS) at 1 Week and 1 Month After Operation
[Time Frame: 1 week, 1 month]
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Secondary ID(s)
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IRB 4-2009-0186
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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