Prediction of Post-Cesarean Section Pain (PPCSP)

September 23, 2011 updated by: Ruth Landau, University of Washington
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Recruiting
        • St. Luc Hospital, University Catholic of Louvain
        • Contact:
        • Principal Investigator:
          • Patricia Lavand'homme, MD, PhD
  • Brazil
      • São Paulo, Brazil, 04103-080
        • Recruiting
        • Hospital e Maternidade Santa Joana
        • Contact:
        • Principal Investigator:
          • Monica Cardoso, MD, PhD
  • Singapore
      • Singapore, Singapore, 229899
        • Recruiting
        • KK Women's and Children's Hospital
        • Contact:
        • Principal Investigator:
          • Alex Sia Tiong Heng, M.Med
  • United States
    • California
      • Stanford, California, United States, 94305
        • Active, not recruiting
        • Stanford University
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington
        • Contact:
        • Principal Investigator:
          • Ruth Landau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with a scheduled elective cesarean section

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

November 1, 2012

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 25, 2008

First Posted (Estimate)

November 27, 2008

Study Record Updates

Last Update Posted (Estimate)

September 26, 2011

Last Update Submitted That Met QC Criteria

September 23, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35115-A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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