Prediction of Post-Cesarean Section Pain

NCT ID: NCT00799162

Last Updated: 2011-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with a scheduled cesarean section

Psychophysical testing, questionnaires, and genetics

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Ruth Landau

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status ACTIVE_NOT_RECRUITING

University of Washington

Seattle, Washington, United States

Site Status RECRUITING

St. Luc Hospital, University Catholic of Louvain

Brussels, Brussels Capital, Belgium

Site Status RECRUITING

Hospital e Maternidade Santa Joana

São Paulo, São Paulo, Brazil

Site Status RECRUITING

KK Women's and Children's Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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United States Belgium Brazil Singapore

Central Contacts

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Lisa Y Flint, BS

Role: CONTACT

(206) 543-7817

Katrina L Golub, MPH

Role: CONTACT

(206) 616-9209

Facility Contacts

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Lisa Y Flint, BS

Role: primary

206-543-2187

Patricia Lavand'hoome, MD, PhD

Role: primary

(+32) 02 764 18 21

Monica Cardoso, MD, PhD

Role: primary

(11)5080-6068

Ban Leong

Role: primary

References

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Ortner CM, Turk DC, Theodore BR, Siaulys MM, Bollag LA, Landau R. The Short-Form McGill Pain Questionnaire-Revised to evaluate persistent pain and surgery-related symptoms in healthy women undergoing a planned cesarean delivery. Reg Anesth Pain Med. 2014 Nov-Dec;39(6):478-86. doi: 10.1097/AAP.0000000000000158.

Reference Type DERIVED
PMID: 25304476 (View on PubMed)

Other Identifiers

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35115-A

Identifier Type: -

Identifier Source: org_study_id