Chronic PainPREDONCT01767168
Study to Test the Value of a Pain Modulation Test in Predicting Persistent Postoperative Pain After Breast Cancer Surgery
An observational study of Chronic Pain and Acute Pain, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain, Acute Pain
- What is being tested?
- comprehensive preoperative testing for risk factors of persistent postoperative pain
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to May 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women scheduled for any type of breast cancer surgery in a university hospital breast cancer center
Who may be able to join
- age >=18 years
- American Society of Anesthesiology functional status I-III
- able to read and understand the information sheet and give informed consent
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève
Geneva, Canton of Geneva, 1211
About this study
Official title: Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test
The purpose of this study is to test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.
- Conditions
- Chronic Pain, Acute Pain
- Being tested
- comprehensive preoperative testing for risk factors of persistent postoperative pain
- Medical subject headings
- Chronic Pain, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive preoperative testing for risk factors of persistent postoperative painOther
nociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of pain at the site of surgery
clinically important pain defined as either necessitating analgesic treatment or having an intensity of more than 3/10 at rest or 5/10 on movement, at 4 months after surgery
Measured: 4 months postop
Secondary outcomes (5)
acute pain
maximum pain >3/10
Measured: 24h
subacute pain
average pain, maximum pain >2
Measured: 1 week
prevalence of pain necessitating analgesics at the site of surgery
Measured: 4 months
prevalence of pain at the site of surgery
Measured: 8 months
prevalence of pain at the site of surgery
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startMay 2011
- Primary completionApr 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benno Rehberg-Klug, University Hospital, Geneva
- Investigators
- Benno Rehberg-Klug, MD, Principal investigator, Dept of Anesthesiology, HUG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767168
- Sponsor's protocol ID
- CER 10-218
- Other IDs
- matped 10-054
- Acronym
- PREDO
- Status last verified
- Jul 2016
- First submitted
- 10 Jan 2013
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Diagnostic Accuracy for the Prediction of Persistent Postoperative Pain After Breast Cancer Surgery Using a Conditioned Pain Modulation Test
- ClinicalTrials.gov ID
- NCT01767168
- Acronym / sponsor ID
- PREDO / CER 10-218
- Conditions
- Chronic Pain, Acute Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 14 Jan 2013 (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 test the hypothesis that a preoperative test of pain modulation predicts persistent pain 4 months after breast cancer surgery. In addition, a risk score for the prediction of persistent pain will be developed from parameters available before surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women scheduled for any type of breast cancer surgery in a university hospital breast cancer center
Key inclusion criteria (3 listed)
- age >=18 years
- American Society of Anesthesiology functional status I-III
- able to read and understand the information sheet and give informed consent
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| comprehensive preoperative testing for risk factors of persistent postoperative painnociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences | Other | – |
Primary outcome
prevalence of pain at the site of surgery
Time frame: 4 months postop
clinically important pain defined as either necessitating analgesic treatment or having an intensity of more than 3/10 at rest or 5/10 on movement, at 4 months after surgery
5 secondary outcomes
acute pain
Time frame: 24h
subacute pain
Time frame: 1 week
prevalence of pain necessitating analgesics at the site of surgery
Time frame: 4 months
prevalence of pain at the site of surgery
Time frame: 8 months
prevalence of pain at the site of surgery
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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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.
Benno Rehberg-Klug, MD principal investigator
Dept of Anesthesiology, HUG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Acute Pain, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of pain at the site of surgery (time frame: 4 months postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2016.