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Main
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Note: This record shows only the 20 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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ChiCTR |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
ChiCTR-TRC-11001416 |
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Date of registration:
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2011-07-13 |
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Primary sponsor: |
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Public title:
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Effects, Safety, and Cost Efficacy of Controlled-Release Oxycodone for Pain Control in Transarterial Chemoembolization Therapy for Patients with Liver Cancers
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Scientific title:
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Effects, Safety, and Cost Efficacy of Controlled-Release Oxycodone for Pain Control in Transarterial Chemoembolization Therapy for Patients with Liver Cancers |
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Date of first enrolment:
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2009-05-01 |
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Target sample size:
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B:70;A:70;C:70; |
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Recruitment status: |
Completed |
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URL:
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http://www.chictr.org/en/proj/show.aspx?proj=1576 |
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Study type:
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Interventional |
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Study design:
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Randomized parallel control
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Countries of recruitment
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China
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Contacts
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Name:
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Bo Zhou
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Address:
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180 Fenglin Road Shanghai, People's Republic of China
200032
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Telephone:
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+86 13621604953 |
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Email:
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bonheurzhou@hotmail.com |
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Affiliation:
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Name:
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Jianhua Wang
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Address:
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180 Fenglin Road Shanghai, People's Republic of China
200032
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Telephone:
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+86 21 64041990-3088 |
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Email:
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wangjianhua2011@sina.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: patients with age of 18 or older, scheduled for TACE
Exclusion criteria: American Society of Anesthesiologists (ASA) physical status > III, known allergic or intolerant to CRO, pregnant, a history of drug abuse, history of long time opioid medication, history of postoperative nausea and vomiting (PONV), history of ileus, liver dysfunction defined as elevation of serum alanine aminotransferase and serum aspartate aminotransferase three times above the upper normal range.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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liver cancer
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Intervention(s)
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B:20mg controlled-release oxycodone given from one hour before chemoembolization (TACE) therapy and every 12 hours until 48hours after TACE;A:10mg controlled-release oxycodone given from one hour before chemoembolization (TACE) therapy and every 12 hours until 48hours after TACE;C:placebo pills (containing 100 mg Vitamin C) given from one hour before chemoembolization (TACE) therapy and every 12 hours until 48hours after TACE;
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Primary Outcome(s)
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pain score (NRS);
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Secondary Outcome(s)
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morphine consumption;life quality;
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Source(s) of Monetary Support
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Department of Interventional Radiology, Fudan University, Shanghai Medical College, Zhongshan Hospital
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