Severity Postoperative Pain Prediction

Pain Clinical Trial

Official title:

Predicting Severity of Postoperative Pain After Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00638404
• Other study ID #: Pain Prediction
• Status: Terminated
• Start date: August 2007
• Est. completion date: September 2009

Study information

• Verified date: August 2017
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 300
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Pain
• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
United States	Forsyth Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 at 24 hours
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	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	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	anticipated anxiety prior to surgery