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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 February 2015 |
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Main ID: |
NCT00938171 |
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Date of registration:
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10/07/2009 |
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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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Comparing Local Anesthesia With General Anesthesia for Breast Cancer Surgery
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Scientific title:
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A Comparison of Local Anesthesia and General Anesthesia for Breast Cancer Surgery, a Prospective Randomized Trial |
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Date of first enrolment:
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June 2008 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00938171 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Taiwan
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Contacts
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Name:
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YuanChing Chang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mackay Memorial Hospital |
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Name:
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Yuan-Ching Chang, MD |
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Address:
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Telephone:
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886-2-25433535 |
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Email:
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yuanching.chang@gmail.com |
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Affiliation:
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Name:
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Yuan-Ching Chang, MD |
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Address:
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Telephone:
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886-2-25433535 |
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Email:
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yuanching.chang@gmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Biopsy-proven breast cancer Scheduled for mastectomy and axillary node dissection in
a single procedure.
Exclusion Criteria:
- previous surgery within the preceding 2 wk those other than ASA physical status I or
II any contraindication to either local anesthesia or opioid analgesia
Age minimum:
21 Years
Age maximum:
75 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Procedure: Local anesthesia
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Procedure: General anesthesia
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Primary Outcome(s)
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Visual Analog Scale (VAS) pain scores
[Time Frame: Until PACU discharge and for 24 hours]
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Secondary Outcome(s)
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disease free survival
[Time Frame: 5 years]
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Episodes of nausea or vomiting
[Time Frame: 24 hours]
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Overall patient satisfaction
[Time Frame: After hospital discharge and six months later]
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The need for postoperative opioids
[Time Frame: 24 hours]
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Secondary ID(s)
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97WHK0900049
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MMH-I-S538
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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