Prediction of Post-Cesarean Section Pain - Full Text View

Sponsored by:	University of Washington
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00799162

Purpose

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.

Condition	Intervention
Postoperative Pain	Other: Psychophysical testing, questionnaires, and genetics

MedlinePlus related topics: Cesarean Section

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prediction of Post-Cesarean Section Pain

Further study details as provided by University of Washington:

Biospecimen Retention: Samples With DNA

Biospecimen Description:

whole blood

Estimated Enrollment:	200
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Women with a scheduled cesarean section	Other: 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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Women with a scheduled elective cesarean section

Criteria

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 one previous cesarean section
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799162

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

More Information

Responsible Party:	University of Washington ( Ruth Landau, MD )
Study ID Numbers:	35115
Study First Received:	November 25, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00799162
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Signs and Symptoms
Postoperative Complications
Pain
Pain, Postoperative

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009