Severity Postoperative Pain Prediction - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

March 12, 2008

Last Updated Date

February 26, 2009

Start Date ^†

August 2007

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00638404 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Severity Postoperative Pain Prediction

Official Title ^†

Predicting Severity of Postoperative Pain After Surgery

Brief Summary

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.

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.

Study Phase

Study Type ^†

Observational

Study Design ^†

Other, Prospective

Condition ^†

Anxiety
Pain
Postoperative Pain

Intervention ^†

Study Arms / Comparison Groups

Elective Cesarean Sections
Post partum bilateral tubal ligations
Any in-patient gynecologic procedure- this portion completed

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

400

Completion Date

Primary Completion Date

Eligibility 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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Lynne C. Harris, BSN, CCRC

336-716-9957

lcharris@wfubmc.edu

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00638404

Responsible Party

Peter H. Pan, MD, Wake Forest University Health Sciences

Secondary IDs ^††

Study Sponsor ^†

Wake Forest University

Collaborators ^††

National Institute of General Medical Sciences (NIGMS)

Investigators ^†

Principal Investigator:

Peter H. Pan, MSEE, MD

Wake Forest University

Information Provided By

Wake Forest University

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.