Postoperative PainPPCSPNCT00799162
Prediction of Post-Cesarean Section Pain
An observational study of Postoperative Pain, run by University of Washington at 5 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Psychophysical testing, questionnaires, and genetics
- How many people
- 800 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Nov 2008to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with a scheduled elective cesarean section
Who may be able to join
- Women age 18-50 scheduled for an elective cesarean section (1st or 2nd cesarean section)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites, 1 recruiting
- Recruiting
University of Washington
Seattle, Washington, 98195
Lisa Y Flint, BS, 206-543-2187, lyflint@u.washington.edu
Ruth Landau, MD
- Active, not recruiting
Stanford University
Stanford, California, 94305
Belgium1 site, 1 recruiting
- Recruiting
St. Luc Hospital, University Catholic of Louvain
Brussels, Brussels Capital, 1200
Patricia Lavand'hoome, MD, PhD, (+32) 02 764 18 21, patricia.lavandhomme@uclouvain.be
Patricia Lavand'homme, MD, PhD
Brazil1 site, 1 recruiting
- Recruiting
Hospital e Maternidade Santa Joana
São Paulo, São Paulo, 04103-080
Monica Cardoso, MD, PhD, (11)5080-6068, monicascardoso@terra.com.br
Monica Cardoso, MD, PhD
Singapore1 site, 1 recruiting
- Recruiting
KK Women's and Children's Hospital
Singapore, 229899
Ban Leong, blsngdr@yahoo.com.sg
Alex Sia Tiong Heng, M.Med
About this study
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.
- Conditions
- Postoperative Pain
- Being tested
- Psychophysical testing, questionnaires, and genetics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychophysical testing, questionnaires, and geneticsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Women with a scheduled cesarean section | Not described Receives: Other: Psychophysical testing, questionnaires, and genetics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2012 (estimated)
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth Landau, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799162
- Sponsor's protocol ID
- 35115-A
- Acronym
- PPCSP
- Status last verified
- Sep 2011
- First submitted
- 25 Nov 2008
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Post-Cesarean Section Pain
- ClinicalTrials.gov ID
- NCT00799162
- Acronym / sponsor ID
- PPCSP / 35115-A
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 27 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with a scheduled cesarean section | – | Other: Psychophysical testing, questionnaires, and genetics |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with a scheduled elective cesarean section
Key inclusion criteria (1 listed)
- Women age 18-50 scheduled for an elective cesarean section (1st or 2nd cesarean section)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychophysical testing, questionnaires, and geneticspre-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 | Other | Women with a scheduled cesarean section |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2011.
- Derived from this study: PubMed 25304476Ortner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by University of Washington at 5 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Brazil, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Y Flint, BS ((206) 543-7817, lyflint@u.washington.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00799162, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2011; AzTrials last refreshed its copy on 4 Nov 2026.