Comparison of Pain Therapeutic Effects After Benign Mastectomy (COPTEAM)
This study has been completed.
Sponsor:
Nanjing Medical University
Information provided by:
Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT00519246
First received: August 21, 2007
Last updated: March 30, 2009
Last verified: March 2009
| Tracking Information | |||||
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| First Received Date ICMJE | August 21, 2007 | ||||
| Last Updated Date | March 30, 2009 | ||||
| Start Date ICMJE | February 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Visual analog scale (VAS) rating of pain [ Time Frame: 0-24h after surgeries ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00519246 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Pain Therapeutic Effects After Benign Mastectomy | ||||
| Official Title ICMJE | Clinical Comparison of Postoperative Pain Therapeutic Effects After Benign Mastectomy | ||||
| Brief Summary | With the incremental trend of benign breast tumor, the surgical process of mastectomy was proceeded too much every day, especially in the Maternal Health Care Hospital, but whether the investigators can find another way to relieve the postoperative pain after such an operation is still unknown. The investigators hypothesized that the pain from the relatively small surgery may not be significant compared to different treatments, even if no drug was delivered to them. The investigators are enrolling patients who underwent mastectomy from benign breast tumor, and are observing the analgesic effects of different drugs. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Shen X, Wang F, Xu S, Ma L, Liu Y, Feng S, Wang W, Zhao Q, Li X, Zhao L, Yao X, Qu J, Xie B, Wang H, Yuan H, Cao Y, Sun Y, Wang W, Guo L, Song Z, Wang Z, Guan X. Comparison of the analgesic efficacy of preemptive and preventive tramadol after lumpectomy. Pharmacol Rep. 2008 May-Jun;60(3):415-21. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 2000 | ||||
| Completion Date | December 2007 | ||||
| Primary Completion Date | December 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00519246 | ||||
| Other Study ID Numbers ICMJE | NMU-2579-4FW, NMCH2007-241 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | XiaoFeng Shen, Nanjing Maternal and Child Health Hospital | ||||
| Study Sponsor ICMJE | Nanjing Medical University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Nanjing Medical University | ||||
| Verification Date | March 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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