Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery
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| First Received Date ICMJE | February 28, 2012 | ||||||||
| Last Updated Date | March 8, 2012 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01552226 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Compare Preperitoneal Analgesia to Epidural Analgesia for Pain Control After Colon and Rectal Surgery | ||||||||
| Official Title ICMJE | Prospective Randomized Clinical Trial to Compare Continuous Preperitoneal Analgesia to Continuous Epidural Analgesia for Pain Control After Colon and Rectal Surgery | ||||||||
| Brief Summary | This is a prospective randomized study of 114 patients. The purpose of this study is to compare the efficacy of two standard methods of analgesia for pain control in patients undergoing elective colon and rectal surgery, as measured by the Numeric Pain Scale (NPS) and by the need for supplemental narcotic analgesics. This study is designed to determine if postoperative pain control by local analgesics delivered through preperitoneally placed ON-Q Silver SoakerTM catheters (CPA) is equivalent to continuous epidural analgesia (CEA). |
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| Detailed Description | Background Perioperative analgesia is a vital part of the management of patients undergoing colon and rectal surgery, affecting well being and length of hospital stay. Neuraxial anesthetics infused through epidural or spinal catheters have become commonplace pain management agents for patients. These techniques, however, are labor-intensive and expensive. Alternatively, local analgesics may be administered directly to the surgical wound via silver catheters. Aim Two standard methods of analgesia for pain control for colon and rectal surgery will be evaluated systematically to determine if these two approaches are equivalent in terms of patient pain scores and supplemental narcotic use. Study Design This is a prospective randomized study of 114 participants undergoing elective colon and rectal surgery at an independent academic medical center. The primary outcomes are post-operative pain control and supplemental narcotic usage. Other variables of interest
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Publications * | Not Provided | ||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 137 | ||||||||
| Estimated Completion Date | June 2014 | ||||||||
| Estimated Primary Completion Date | January 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01552226 | ||||||||
| Other Study ID Numbers ICMJE | RCNM 114 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Saint Joseph Mercy Health System | ||||||||
| Study Sponsor ICMJE | Saint Joseph Mercy Health System | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Saint Joseph Mercy Health System | ||||||||
| Verification Date | March 2012 | ||||||||
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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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