Prediction of Post-Cesarean Section Pain

Postoperative Pain Clinical Trial

— PPCSP  

Official title:

Prediction of Post-Cesarean Section Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00799162
• Other study ID #: 35115-A
• Status: Recruiting
• Phase: N/A
• First received: November 25, 2008
• Last updated: September 23, 2011
• Start date: November 2008
• Est. completion date: November 2013

Study information

• Verified date: September 2011
• Source: University of Washington
• Contact: Lisa Y Flint, BS
• Phone: (206) 543-7817
• Email: lyflint[@]u.washington.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: November 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Belgium	St. Luc Hospital, University Catholic of Louvain	Brussels
Brazil	Hospital e Maternidade Santa Joana	São Paulo
Singapore	KK Women's and Children's Hospital	Singapore
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Countries where clinical trial is conducted

United States,  Belgium,  Brazil,  Singapore,