Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2011-09-30
2013-06-30
Brief Summary
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* Hypothesis 1: Patients with depression will have increased analgesic use and longer hospital stays postoperatively
* Hypothesis 2: Patients with anxiety will have increased analgesic use and longer hospital stays postoperatively.
A secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.
Detailed Description
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Methodology: Patients from the University of Oklahoma Urogynecology clinics who have been scheduled to undergo surgery for pelvic organ prolapse will be invited to participate in this study. Informed consent will be obtained prior to study enrollment. Data obtained from a preoperative visit with each participant will include demographic information, medical and surgical histories, and a complete physical examination. After enrollment into the study, each participant will be started on a standardized dose of analgesics. The visual analog scale will be used to assess the level of pain at the surgical site and pain medications will be adjusted as necessary. Information regarding their postoperative course will be tracked, including any complications, use of pain medications, and length of hospital stay.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Abdominal
\- Participants undergoing surgeries with an abdominal approach will be given a Morphine PCA at a dose of 2mg every 10 minutes with a 12mg/hour lockout. They will also be given IV Toradol at 30mg every 6 hours as needed for a maximum of four doses.
No interventions assigned to this group
Vaginal
\- Participants undergoing surgeries with a vaginal approach will be given hydrocodone/acetaminophen at a dose of 5/325 (1-2 tablets every four hours as needed), and provided with Ibuprofen 800mg every 8 hours as needed.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center
Exclusion Criteria
* Inability to complete the written questionnaires
* Undergoing concurrent procedures for condition other than pelvic organ prolapse
21 Years
FEMALE
No
Sponsors
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University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Mikio Nihira, MD
Role: PRINCIPAL_INVESTIGATOR
University of Oklahoma
Locations
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University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Countries
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Other Identifiers
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shobeiridepression_10.18.11
Identifier Type: -
Identifier Source: org_study_id