CClinicalTrials.gg
Status unknownNCT00799162PPCSPUpdated Sep 26, 2011

Prediction of Post-Cesarean Section Pain

An observational study in Postoperative Pain, sponsored by University of Washington. Status unknown at 5 sites in 4 countries. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-26.

Sponsored by University of Washington · Observational

The sponsor has not verified this record recently (last verified Sep 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 50 Years
Sex
Female
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Study 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.

02

Conditions studied

  • Postoperative Pain

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03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 800 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.

Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women with a scheduled elective cesarean section

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Women with a scheduled cesarean section

    Other: Psychophysical testing, questionnaires, and genetics

Interventions

  • OtherPsychophysical 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

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Study locations

4 of 5 sites recruiting
  • Stanford University
    Stanford, California 94305, United States
    Active, not recruiting
  • University of Washington
    Seattle, Washington 98195, United States
    Recruiting
  • St. Luc Hospital, University Catholic of Louvain
    Brussels, 1200, Belgium
    Recruiting
  • Hospital e Maternidade Santa Joana
    São Paulo, 04103-080, Brazil
    Recruiting
  • KK Women's and Children's Hospital
    Singapore, 229899, Singapore
    Recruiting
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References and documents

Publications

  • 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. PubMed 25304476 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00799162
Lead sponsor
University of Washington
Responsible party
Ruth Landau (Professor, University of Washington) — Principal investigator
First posted
Nov 27, 2008
Start date
Nov 2008
Primary completion
Nov 2012 (estimated)
Completion
Nov 2013 (estimated)
Last update
Sep 26, 2011

Study contacts

Lisa Y Flint, BS
Contact
lyflint@u.washington.edu
(206) 543-7817
Katrina L Golub, MPH
Contact
kgerber@u.washington.edu
(206) 616-9209

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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