Breast NeoplasmsNCT02823015
Acute Pain Trajectories and Persistent Pain After Breast Cancer Surgery
An observational study of Breast Neoplasms, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem, affecting between 25 and 50% of patients. Several factors are associated with the development of PPBCS, including acute postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- How many people
- 46 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Mar 2015
- 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: Adult females, scheduled for breast cancer surgery
Who may be able to join
- Scheduled for breast cancer surgery
- General anesthesia
Who cannot join
- Previous breast surgery
- Reconstructive surgery scheduled during follow-up
- Day-surgery patients
- Inability to understand the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Pain Trajectories as a Predictive Factor for Persistent Pain After Breast Cancer Surgery
Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem, affecting between 25 and 50% of patients. Several factors are associated with the development of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed model modeling is an alternative to static pain measures, improving precision and providing information on the time course of pain resolution. Our aim was to investigate if the characteristics of pain trajectories during the first postoperative week are correlated with the persistence of pain 3 months after breast cancer surgery.
- Conditions
- Breast Neoplasms
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | The study population consists of adult surgery patients, scheduled for breast cancer surgery at St-Luc University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No
Measured: 3 months
Secondary outcomes (1)
Acute pain trajectories (7 days) after surgery
The pain trajectory is the vector of 7 verbal numerical pain scores (from 0 to 10) recorded in a pain diary over the first 7 postoperative days
Measured: One postoperative week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startOct 2014
- Primary completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Steyaert, MD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02823015
- Sponsor's protocol ID
- ANES-AS-002
- Status last verified
- Jun 2016
- First submitted
- 30 May 2016
- Last updated
- 6 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pain Trajectories as a Predictive Factor for Persistent Pain After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02823015
- Acronym / sponsor ID
- ANES-AS-002
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- First posted
- 6 Jul 2016 (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.
Persistent pain after breast cancer surgery (PPBCS) is a significant clinical problem, affecting between 25 and 50% of patients. Several factors are associated with the development of PPBCS, including acute postoperative pain. The analysis of pain trajectories through mixed model modeling is an alternative to static pain measures, improving precision and providing information on the time course of pain resolution. Our aim was to investigate if the characteristics of pain trajectories during the first postoperative week are correlated with the persistence of pain 3 months after breast cancer surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –The study population consists of adult surgery patients, scheduled for breast cancer surgery at St-Luc University Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult females, scheduled for breast cancer surgery
Key inclusion criteria (2 listed)
- Scheduled for breast cancer surgery
- General anesthesia
Key exclusion criteria (4 listed)
- Previous breast surgery
- Reconstructive surgery scheduled during follow-up
- Day-surgery patients
- Inability to understand the questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No
Time frame: 3 months
1 secondary outcome
Acute pain trajectories (7 days) after surgery
Time frame: One postoperative week
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 6 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Arnaud Steyaert, MD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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 Breast Neoplasms, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 4 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 6 Jul 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 Belgium. 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?
Presence of pain 3 months after surgery, assessed with the Brief Pain Inventory questionnaire. Yes/No (time frame: 3 months). 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 6 Jul 2016.