Clinical trial NCT00638404: Severity Postoperative Pain Prediction
Official title: Predicting Severity of Postoperative Pain After Surgery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Anxiety
Pain
Postoperative Pain
Keywords: Preoperative somatic questions
Preoperative audio tone evaluations
Preoperative anxiety and previous experience with postop pain
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2008-03-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: scheduled for elective cesarean section, non-pregnant subjects scheduled for inpatient gynecological surgeries

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.

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

Primary outcomes:
measure: Evoked Pain at 24 Hours VAS
timeFrame: evoked pain at 24 hours
Secondary outcomes:
measure: Anticipated Pain Medication Requirement
timeFrame: 24 hours
measure: Anticipated Postoperative Pain at Preoperative Evaluation
timeFrame: anticipated postoperative pain
measure: Anxiety
timeFrame: anticipated anxiety prior to surgery
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Forsyth Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Peter H. Pan, MSEE, MD
role: PRINCIPAL_INVESTIGATOR
References: