Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery
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First Received Date ICMJE | September 8, 2010 | ||||||||
Last Updated Date | September 28, 2011 | ||||||||
Start Date ICMJE | September 2010 | ||||||||
Estimated Primary Completion Date | September 2011 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Patient Pain Control [ Time Frame: post operative day 1 ] [ Designated as safety issue: No ] Patient's reported pain on a VAS on all postoperative day one. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01442818 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 | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery | ||||||||
Official Title ICMJE | Patient Satisfaction and Pain Control Following Reconstructive Vaginal Surgery: A Randomized Trial Comparing Patient-Controlled Intravenous Analgesia (PCA) to Scheduled Intravenous Analgesia | ||||||||
Brief Summary | The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery. |
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Detailed Description | The investigators hypothesize that patient controlled analgesia (PCA) provides superior pain relief and patient satisfaction when compared to scheduled intravenous analgesia following vaginal reconstructive surgery. In order to determine if there is a significant correlation, secondary outcomes will include the daily and total narcotic volume used, common side effects from the opioid including nausea, vomiting, or pruritis, length of hospital stay, timing of flatus and first bowel movement, all complications, and procedure performed. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Post Operative Pain | ||||||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||||||
* 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 | 54 | ||||||||
Estimated Completion Date | October 2012 | ||||||||
Estimated Primary Completion Date | September 2011 (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 70 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01442818 | ||||||||
Other Study ID Numbers ICMJE | 10072 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
Responsible Party | Catrina C. Crisp Harmon, TriHealth Inc. | ||||||||
Study Sponsor ICMJE | TriHealth Inc. | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | TriHealth Inc. | ||||||||
Verification Date | September 2011 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |