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Severity Postoperative Pain Prediction
This study is currently recruiting participants.
Verified by Wake Forest University, February 2009
First Received: March 12, 2008   Last Updated: February 26, 2009   History of Changes
Sponsors and Collaborators: Wake Forest University
National Institute of General Medical Sciences (NIGMS)
Information provided by: Wake Forest University
ClinicalTrials.gov Identifier: NCT00638404
  Purpose

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
Anxiety
Pain
Postoperative Pain

Study Type: Observational
Study Design: Prospective
Official Title: Predicting Severity of Postoperative Pain After Surgery

Resource links provided by NLM:


Further study details as provided by Wake Forest University:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 400
Study Start Date: August 2007
Groups/Cohorts
1
Elective Cesarean Sections
2
Post partum bilateral tubal ligations
3
Any in-patient gynecologic procedure- this portion completed

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries, non-pregnant subjects scheduled for postpartum bilateral tubal ligations

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00638404

Contacts
Contact: Lynne C. Harris, BSN, CCRC 336-716-9957 lcharris@wfubmc.edu

Locations
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            
Sponsors and Collaborators
Wake Forest University
Investigators
Principal Investigator: Peter H. Pan, MSEE, MD Wake Forest University
  More Information

No publications provided

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

Keywords provided by Wake Forest University:
Preoperative somatic questions
Preoperative audio tone evaluations
Preoperative anxiety and previous experience with postop pain

Study placed in the following topic categories:
Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:
Signs and Symptoms
Pathologic Processes
Postoperative Complications
Pain
Pain, Postoperative

ClinicalTrials.gov processed this record on September 10, 2009