Recruiting

Pain Prediction

Sponsor:

University of Washington

Code:

NCT00799162

Conditions

Postoperative Pain

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Psychophysical testing, questionnaires, and genetics

Study Details

Brief summary:

The purpose of this study is to determine if dynamic psychophysical testing along with genetic screening will allow to identify pre-operatively women who will suffer severe acute pain post-operatively and the subset who may experience chronic pain following cesarean section.

Conditions

Postoperative Pain

Study ID

NCT00799162

Start date

Nov, 2008

Status verified date

Sep, 2011

Completion date

Nov, 2013

Anticipated

Primary completion date

Nov, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Women age 18-50 scheduled for an elective cesarean section (1st or 2nd cesarean section)

Exclusion Criteria:

Women who:

  • have taken opioids, acetaminophen, or NSAIDs 48 hrs prior to psychophysical testing
  • have had more than two previous cesarean sections
  • have a vertical abdominal incision from a prior cesarean section
  • are non-English speaking
  • have mental health issues
  • have a failure of spinal anesthetic and require conversion to general anesthesia
  • have a vertical uterine incision performed during ongoing cesarean section
  • have a previous vertical uterine scar discovered during ongoing cesarean section

Study Design

Enrollment

800 participants

Anticipated

Interventions and Outcome Measures

Arms

Women with a scheduled cesarean section

Interventions

Psychophysical testing, questionnaires, and genetics

pre-operative psychophysical testing of endogenous pain modulation, pre-operative questionnaires, peri- and post-operative data collection, long term follow-up assessing chronic pain, SNP association analysis, and whole genome scanning association studies

Central Contacts and Locations

Central contacts

Lisa Y Flint, BS

(206) 543-7817lyflint@u.washington.edu

Katrina L Golub, MPH

(206) 616-9209kgerber@u.washington.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Lisa Y Flint, BS

206-543-2187lyflint@u.washington.edu

Principal Investigator:

Ruth Landau, MD

More Information

Sponsor

University of Washington

Last update posted

Sep 26, 2011

Last verified

Sep, 2011

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2011-09-26.