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Sponsors and Collaborators: |
Wake Forest University National Institute of General Medical Sciences (NIGMS) |
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Information provided by: | Wake Forest University |
ClinicalTrials.gov Identifier: | NCT00638404 |
A simple preoperative evaluation assessing level of anxiety, anticipated pain, and intensity rating of audio tone will predict the severity of postoperative pain after surgery.
Condition |
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Anxiety Pain Postoperative Pain |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Predicting Severity of Postoperative Pain After Surgery |
Estimated Enrollment: | 400 |
Study Start Date: | August 2007 |
Groups/Cohorts |
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1
Elective Cesarean Sections
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2
Post partum bilateral tubal ligations
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Any in-patient gynecologic procedure- this portion completed
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The purpose of this study would be to determine the predictive value of a simple to perform preoperative evaluation in assessing level of anxiety, anticipated pain and the intensity rating of an audio tone to predict level of postoperative pain after surgery.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries, non-pregnant subjects scheduled for postpartum bilateral tubal ligations
Inclusion Criteria:
Exclusion Criteria:
Contact: Lynne C. Harris, BSN, CCRC | 336-716-9957 | lcharris@wfubmc.edu |
United States, North Carolina | |
Forsyth Medical Center | Recruiting |
Winston-Salem, North Carolina, United States, 27103 | |
Principal Investigator: Peter H. Pan, MSEE, MD | |
Sub-Investigator: James Eisenach, MD |
Principal Investigator: | Peter H. Pan, MSEE, MD | Wake Forest University |
Responsible Party: | Wake Forest University Health Sciences ( Peter H. Pan, MD ) |
Study ID Numbers: | Pain Prediction |
Study First Received: | March 12, 2008 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00638404 History of Changes |
Health Authority: | United States: Institutional Review Board |
Preoperative somatic questions Preoperative audio tone evaluations Preoperative anxiety and previous experience with postop pain |
Signs and Symptoms Postoperative Complications Pain Pain, Postoperative |
Signs and Symptoms Pathologic Processes Postoperative Complications Pain Pain, Postoperative |