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Further evaluation determined it was not feasible to enroll the post-partum tubal ligation group at our facility
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Elective Cesarean Sections-this portion completed | ||
| 3 | Any in-patient gynecologic procedure- this portion completed |
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| Measure | Description | Time Frame |
|---|---|---|
| Evoked Pain at 24 Hours VAS | Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain | evoked pain at 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Anticipated Pain Medication Requirement | measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required | 24 hours |
| Anticipated Postoperative Pain at Preoperative Evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries
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| Name | Affiliation | Role |
|---|---|---|
| Peter H. Pan, MSEE, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Forsyth Medical Center | Winston-Salem | North Carolina | 27103 | United States |
no randomization, only observational study
200 Elective cesarean sections and 100 gynecological patients were enrolled prior to their surgery with presurgical testing completed. All subjects were then also seen postoperatively for followup
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| ID | Title | Description |
|---|---|---|
| FG000 | 1-elective Cesarean Section | Elective Cesarean Sections-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively |
| FG001 | 3-inpatient Gynecologic Procedures | Any in-patient gynecologic procedure-preoperative questionnaire as well as audio testing completed prior to surgery with followup done 24 hours postoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1-elective Cesarean Sections | Elective Cesarean Sections-this portion completed |
| BG001 | 3-inpatient Gynecologic Procedures | Any in-patient gynecologic procedure- this portion completed |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evoked Pain at 24 Hours VAS | Outcome measure 0-100 Visual analog scale at 24 hours postoperatively, VAS of 0= no pain up to 100 =most severe pain | evoked pain outcome-measured on a scale of 0=no pain up to 100=most severe pain imaginable. | Posted | Mean | Standard Deviation | units on a scale | evoked pain at 24 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1-elective Cesarean Sections | Elective Cesarean Sections-this portion completed |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter H. Pan MD, MSEE | Wake Forest School of Medicine-Anesthesiology | 336-718-8278 | ppan@wakehealth.edu |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable
| anticipated postoperative pain |
| Anxiety | measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious | anticipated anxiety prior to surgery |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Anticipated Pain Medication Requirement | measured on a scale of 0-5, with 0=no anticipated pain medication needed up to 5 =most anticipated pain medication required | Posted | Median | Full Range | units on a scale | 24 hours |
|
|
|
|
| Secondary | Anticipated Postoperative Pain at Preoperative Evaluation | anticipated postoperative pain on a scale of 0-100mm with 0=no anticipated pain at all up to 100= worst anticipated pain imaginable | Posted | Mean | Standard Deviation | units on a scale | anticipated postoperative pain |
|
|
|
|
| Secondary | Anxiety | measure of anticipated anxiety for on a scale of 0-100, with 0= not anxious at all up to 100 = most anxious | Posted | Mean | Standard Deviation | units on a scale | anticipated anxiety prior to surgery |
|
|
|
|
| 0 |
| 192 |
| 0 |
| 192 |
| 0 |
| 192 |
| EG001 | 3-inpatient Gynecologic Procedures | Any in-patient gynecologic procedure- this portion completed | 0 | 100 | 0 | 100 | 0 | 100 |
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| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |