Study Results
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View full resultsBasic Information
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TERMINATED
300 participants
OBSERVATIONAL
2007-08-31
2009-09-30
Brief Summary
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Detailed Description
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Study Design: A total of 400 evaluable patients will be studied using the various surgical populations listed. For statistical purposes, the following will be the surgical population by procedure. Two hundred healthy ASA I-II women scheduled for elective cesarean section, one hundred scheduled for elective postpartum tubal ligations, and one hundred scheduled for elective inpatient gynecological surgeries (such as total vaginal hysterectomy, total abdominal hysterectomy) will be consented and enrolled in the study. Normal baseline vital signs will be obtained and recorded as part of usual preoperative assessment for these patients. The patients will be asked about their current level of pain and to rate the intensity of a series of audio tones. At 18-24 hours postoperatively, and again at 36-48 hours postoperatively if applicable, research personnel will evaluate the severity of postoperative pain the patient has at rest and with movement (from supine to sitting upright), using a sliding pain scale from 0 to 100 mm, with 0 being no pain and 100 being the worst pain ever. Information on drug administered in the preoperative, intraoperative and postoperative period will be collected and recorded. The subject can also choose to allow us to follow-up with them in the future to evaluate current residual postoperative pain levels as needed.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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1
Elective Cesarean Sections-this portion completed
No interventions assigned to this group
3
Any in-patient gynecologic procedure- this portion completed
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Aged 18 years or above
* Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections
Exclusion Criteria
* \< 36 weeks for Cesarean Section
* \< 18 years of age
18 Years
FEMALE
No
Sponsors
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Wake Forest University
OTHER
Responsible Party
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Principal Investigators
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Peter H. Pan, MSEE, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Forsyth Medical Center
Winston-Salem, North Carolina, United States
Countries
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Other Identifiers
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Pain Prediction
Identifier Type: -
Identifier Source: org_study_id
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