Breast CancerNCT03307525
Pain After Breast Surgery
An observational study of Breast Cancer and Surgery, run by Duke University.
Trial summary
This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Surgery
- How many people
- 141 participants
- Where
- No sites listed yet
- Study dates
- 20 Jun 2012to 22 Dec 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: Women undergoing elective breast cancer surgery
Who may be able to join
- English speaking undergoing elective breast cancer surgery
Who cannot join
- Patients with recurrent cancer, metastasis, and previous breast surgery
About this study
Official title: A Pilot Study Assessing the Correlation of Preoperative Sensory Testing and Genetic Polymorphisms With Acute and Persistent Postoperative Pain
This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.
- Conditions
- Breast Cancer, Surgery
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Pain
Maximum pain score reported postoperatively
Measured: 72 hours after surgery
Secondary outcomes (1)
Persistent Pain
pain score ≥ 3 or pain that impacts daily life as indicated by a score >0 on any of the 7 daily activity questions more than 6 months after surgery
Measured: More than 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start20 Jun 2012
- Primary completion22 Dec 2015
- Study completion22 Dec 2015
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 Breast CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Ambulatory Anesthesia (SAMBA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307525
- Sponsor's protocol ID
- Pro00026402
- Status last verified
- Oct 2017
- First submitted
- 3 Oct 2017
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.
PubMed 30700614
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Correlation of Preoperative Sensory Testing and Genetic Polymorphisms With Acute and Persistent Postoperative Pain
- ClinicalTrials.gov ID
- NCT03307525
- Acronym / sponsor ID
- Pro00026402
- Conditions
- Breast Cancer, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Society for Ambulatory Anesthesia (SAMBA)
- Study start
- 20 Jun 2012 (actual)
- Primary completion
- 22 Dec 2015 (actual)
- Study completion
- 22 Dec 2015 (actual)
- First posted
- 11 Oct 2017 (actual)
- 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.
This is a pilot observational study assessing various predictors for acute pain and persistent pain following breast surgery for cancer.
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 undergoing elective breast cancer surgery
Key inclusion criteria (1 listed)
- English speaking undergoing elective breast cancer surgery
Key exclusion criteria (1 listed)
- Patients with recurrent cancer, metastasis, and previous breast surgery
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
Acute Pain
Time frame: 72 hours after surgery
Maximum pain score reported postoperatively
1 secondary outcome
Persistent Pain
Time frame: More than 6 months after surgery
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 26 Oct 2023.
- Derived from this study: PubMed 30700614Habib AS, Kertai MD, Cooter M, Greenup RA, Hwang S. Risk factors for severe acute pain and persistent pain after surgery for breast cancer: a prospective observational study. Reg Anesth Pain Med. 2019 Feb;44(2):192-199. doi: 10.1136/rapm-2018-000040. Epub 2019 Jan 5.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Surgery, run by Duke University.
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 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Acute Pain (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307525, 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 Oct 2023; AzTrials last refreshed its copy on 27 Oct 2026.