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.

Study Overview

• Status: Terminated
• Conditions: Pain; Postoperative Pain; Anxiety

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Forsyth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Elective Cesarean Sections-this portion completed
3; Any in-patient gynecologic procedure- this portion completed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University
• Investigators: Principal Investigator: Peter H. Pan, MSEE, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: March 12, 2008
• First Submitted That Met QC Criteria: March 12, 2008
• First Posted (Estimate): March 19, 2008

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: November 6, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Preoperative somatic questions; Preoperative audio tone evaluations; Preoperative anxiety and previous experience with postop pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Pain Prediction

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No