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
  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: Time Perspective: Prospective
Official Title: Predicting Severity of Postoperative Pain After Surgery

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

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 ]

Enrollment: 300
Study Start Date: August 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Elective Cesarean Sections-this portion completed
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, North Carolina
Forsyth Medical Center
Winston-Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Peter H. Pan, MSEE, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Peter H. Pan, MD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00638404     History of Changes
Other Study ID Numbers: Pain Prediction
Study First Received: March 12, 2008
Last Updated: February 1, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 01, 2014