Severity Postoperative Pain Prediction

This study has been terminated.
(Further evaluation determined it was not feasible to enroll the post-partum tubal ligation group at our facility)
Sponsor:
Collaborator:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00638404
First received: March 12, 2008
Last updated: February 1, 2010
Last verified: September 2009

March 12, 2008
February 1, 2010
August 2007
September 2009   (final data collection date for primary outcome measure)
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. [ Time Frame: Preoperative testing with postoperative followup up to 48 hours postop ] [ Designated as safety issue: No ]
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. [ Time Frame: At end of study ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00638404 on ClinicalTrials.gov Archive Site
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Severity Postoperative Pain Prediction
Predicting Severity of Postoperative Pain After Surgery

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.

Observational
Time Perspective: Prospective
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Non-Probability Sample

scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries

  • Anxiety
  • Pain
  • Postoperative Pain
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  • 1
    Elective Cesarean Sections-this portion completed
  • 3
    Any in-patient gynecologic procedure- this portion completed
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
300
September 2009
September 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy ASA physical status class 1 or 2
  • Aged 18 years or above
  • Pregnant with intrauterine pregnancy of at least 36 weeks for cesarean sections

Exclusion Criteria:

  • ASA >3
  • < 36 weeks for Cesarean Section
  • < 18 years of age
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00638404
Pain Prediction
Yes
Peter H. Pan, MD, Wake Forest University Health Sciences
Wake Forest School of Medicine
National Institute of General Medical Sciences (NIGMS)
Principal Investigator: Peter H. Pan, MSEE, MD Wake Forest School of Medicine
Wake Forest School of Medicine
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP