Severity Postoperative Pain Prediction

NCT00638404 | Terminated Results DMC

• 1 other identifier: Pain Prediction
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Pain; Postoperative Pain

Keywords

Preoperative somatic questions; Preoperative audio tone evaluations; Preoperative anxiety and previous experience with postop pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Anticipated Pain Medication Requirement

  24 hours

• Anticipated Postoperative Pain at Preoperative Evaluation

  anticipated postoperative pain

• Anxiety

  anticipated anxiety prior to surgery

Study Arms (2)

1

Elective Cesarean Sections-this portion completed

3

Any in-patient gynecologic procedure- this portion completed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• ASA \>3
• \< 36 weeks for Cesarean Section
• \< 18 years of age

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Forsyth Medical Center

Winston-Salem, North Carolina, 27103, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Results Point of Contact

• Title: Peter H. Pan MD, MSEE
• Organization: Wake Forest School of Medicine-Anesthesiology

ppan@wakehealth.edu

336-718-8278

Study Officials

• Peter H. Pan, MSEE, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2008
• First Posted: March 19, 2008
• Study Start: August 1, 2007
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 6, 2018
• Results First Posted: August 6, 2018

Record last verified: 2017-08

Locations

US (1)