BreastNCT01114984
Post-Breast Procedure Pain Syndrome Study
An observational study of Breast and Mastectomy, Segmental, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to better understand and characterize the pain that some patients experience after undergoing various breast surgeries, including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and breast reduction. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast, Mastectomy, Segmental
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jun 2014
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergo breast surgery. (breast biopsy, lumpectomy, simple mastectomy,mastectomy with reconstruction, radical mastectomy, radical mastectomy with reconstruction, cosmetic augmentation and breast reduction)
Who may be able to join
- Patients scheduled to undergo one or more of the breast surgical procedures being studied for this project
- Willingness and ability to sign an informed consent document
- No allergies to anesthetic or analgesic medications
- Female,
- 18-80 years of age
- ASA class I-III adult
Who cannot join
- Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
- Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, or history of chronic pain syndrome or neuropathy.
- Subjects with a history of alcohol or drug abuse within the past 3 months
- Subjects with a history of pain medication abuse
- Any other conditions or use of any medication which may interfere with the conduct of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Prospective Cohort Study to Evaluate the Incidence and Characteristics of Post-Operative Pain Among Patients Undergoing Various Breast Surgeries
The purpose of this study is to better understand and characterize the pain that some patients experience after undergoing various breast surgeries, including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and breast reduction.
Read the detailed description
Post-operative breast pain is one of the most common adverse effects after breast surgery procedures. According to previous studies, anywhere from 20-60% of breast surgery patients report mastalgia as an adverse outcome of surgery (1, 2). Although the exact mechanism has not been well defined, the pain is generally neuropathic in nature and described as a burning sensation, electric and shock like, with a stabbing quality (2,3). The large majority of post-operative mastalgia is therefore believed to be secondary to nerve damage, particularly injury to the intercostobrachial nerve, and less commonly the long thoracic, medial and lateral pectoral, and/or the thoracodorsal nerves. Other reported causes of post-operative breast pain include scarring pain, lymphedema, radiation plexopathy, and hematomas (1-5).
Increasing rates of breast surgeries, whether elective, diagnostic, prophylactic, or therapeutic, warrant a more detailed examination of this pain-syndrome, particularly as previous research in the area is rather limited and narrow. A better understanding of the potential mechanisms causing pain, as well as more accurate and current incidence rates, and comparisons of adverse outcomes among the various options available to patients can help guide physicians towards improved clinical practices and patients towards more informed decision-making. Therefore, we designed this prospective cohort study to better understand the underlying mechanisms which may cause post-operative pain after various types of breast surgeries including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic augmentation, and breast reduction, as well as to compare and contrast incidence, quality, and distribution of the post-operative pain caused by these various surgical procedures.
- Conditions
- Breast, Mastectomy, Segmental
- Keywords
- Pain management, Radical mastectomy, Breast surgery, post-operative pain
- Medical subject headings
- Agnosia, Pain, Postoperative
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 |
|---|---|---|
| 10% after breast biopsy | Incidence Post-operative pain after breast surgery. | |
| 20% after lumpectomy | Incidence Post-operative pain after breast surgery | |
| 30% after simple mastectomy | Incidence Post-operative pain after breast surgery | |
| 50% after mastectomy with reconstruction | Incidence Post-operative pain after breast surgery | |
| 50% after radical mastectomy | Incidence Post-operative pain after breast surgery | |
| 50% after radi mastectomy+reconstruction | Incidence Post-operative pain after breast surgery after radical mastectomy with reconstruction | |
| 40% after cosmetic augmentation | Incidence Post-operative pain after breast surgery | |
| 40% after breast reduction | Incidence Post-operative pain after breast surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain using VRS
prospective cohort evaluation of patients undergoing various breast surgery procedures, followed for a period of 6 months post-operatively, and assessed for post-operative breast pain.
Measured: 6 months
Secondary outcomes (5)
Opioid consumption obtained from the recorded data
Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) Post discharge use of opioid consumption (data obtained from the follow up questionnaires at 1, 2, or 3, then 7 days and at 6 months after surgery)
Measured: 6 months
Postoperative nausea and vomiting using a Verbal Rating Scale
Outcomes will be measured with follow up questionnaires at 1, 2, or 3, then 7 days and 6 months after surgery
Measured: 6 months
Return to normal activities of daily living using follow up questionnaires
Questionnaires will help evaluate patients recovery and return to normal activities of daily living(including dietary intake, bowel and bladder function, physical activities). Patients will be contacted via mail or e-mail.
Measured: 6 months
Patient satisfaction using a verbal rating scale from 0 to 100
Patients will state their satisfaction level on a scale of 0= Not satisfied to 100= Excellent
Measured: 6 months
Hospital stay
Record number of days patients remain in hospital
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2010 (estimated)
- Study startJul 2009
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Why it stopped: Bad design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastStudies 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
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roya Yumul, M.D.,PhD., Cedars-Sinai Medical Center
- Investigators
- Roya Yumul, MD, PhD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114984
- Sponsor's protocol ID
- Pro00019341
- Status last verified
- Feb 2015
- First submitted
- 23 Apr 2010
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Evaluate the Incidence and Characteristics of Post-Operative Pain Among Patients Undergoing Various Breast Surgeries
- ClinicalTrials.gov ID
- NCT01114984
- Acronym / sponsor ID
- Pro00019341
- Conditions
- Breast, Mastectomy, Segmental
- Keywords
- Pain management, Radical mastectomy, Breast surgery, post-operative pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Bad design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 3 May 2010 (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 better understand and characterize the pain that some patients experience after undergoing various breast surgeries, including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic breast augmentation, and breast reduction.
Detailed description
Post-operative breast pain is one of the most common adverse effects after breast surgery procedures. According to previous studies, anywhere from 20-60% of breast surgery patients report mastalgia as an adverse outcome of surgery (1, 2). Although the exact mechanism has not been well defined, the pain is generally neuropathic in nature and described as a burning sensation, electric and shock like, with a stabbing quality (2,3). The large majority of post-operative mastalgia is therefore believed to be secondary to nerve damage, particularly injury to the intercostobrachial nerve, and less commonly the long thoracic, medial and lateral pectoral, and/or the thoracodorsal nerves. Other reported causes of post-operative breast pain include scarring pain, lymphedema, radiation plexopathy, and hematomas (1-5).
Increasing rates of breast surgeries, whether elective, diagnostic, prophylactic, or therapeutic, warrant a more detailed examination of this pain-syndrome, particularly as previous research in the area is rather limited and narrow. A better understanding of the potential mechanisms causing pain, as well as more accurate and current incidence rates, and comparisons of adverse outcomes among the various options available to patients can help guide physicians towards improved clinical practices and patients towards more informed decision-making. Therefore, we designed this prospective cohort study to better understand the underlying mechanisms which may cause post-operative pain after various types of breast surgeries including breast biopsy, lumpectomy, mastectomy, mastectomy with reconstruction, cosmetic augmentation, and breast reduction, as well as to compare and contrast incidence, quality, and distribution of the post-operative pain caused by these various surgical procedures.
Study design
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 10% after breast biopsy | – | –Incidence Post-operative pain after breast surgery. |
| 20% after lumpectomy | – | –Incidence Post-operative pain after breast surgery |
| 30% after simple mastectomy | – | –Incidence Post-operative pain after breast surgery |
| 50% after mastectomy with reconstruction | – | –Incidence Post-operative pain after breast surgery |
| 50% after radical mastectomy | – | –Incidence Post-operative pain after breast surgery |
| 50% after radi mastectomy+reconstruction | – | –Incidence Post-operative pain after breast surgery after radical mastectomy with reconstruction |
| 40% after cosmetic augmentation | – | –Incidence Post-operative pain after breast surgery |
| 40% after breast reduction | – | –Incidence Post-operative pain after breast surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergo breast surgery. (breast biopsy, lumpectomy, simple mastectomy,mastectomy with reconstruction, radical mastectomy, radical mastectomy with reconstruction, cosmetic augmentation and breast reduction)
Key inclusion criteria (6 listed)
- Patients scheduled to undergo one or more of the breast surgical procedures being studied for this project
- Willingness and ability to sign an informed consent document
- No allergies to anesthetic or analgesic medications
- Female,
- 18-80 years of age
Key exclusion criteria (5 listed)
- Patients with known allergy, hypersensitivity or contraindications to anesthetic or analgesic medications
- Patients with clinically-significant medical conditions, such as brain, heart, kidney, endocrine, or liver diseases, or history of chronic pain syndrome or neuropathy.
- Subjects with a history of alcohol or drug abuse within the past 3 months
- Subjects with a history of pain medication abuse
- Any other conditions or use of any medication which may interfere with the conduct of the study
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
Postoperative Pain using VRS
Time frame: 6 months
prospective cohort evaluation of patients undergoing various breast surgery procedures, followed for a period of 6 months post-operatively, and assessed for post-operative breast pain.
5 secondary outcomes
Opioid consumption obtained from the recorded data
Time frame: 6 months
Postoperative nausea and vomiting using a Verbal Rating Scale
Time frame: 6 months
Return to normal activities of daily living using follow up questionnaires
Time frame: 6 months
Patient satisfaction using a verbal rating scale from 0 to 100
Time frame: 6 months
Hospital stay
Time frame: up to 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
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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.
Roya Yumul, MD, PhD principal investigator
Cedars-Sinai Medical Center
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 and Mastectomy, Segmental, run by Cedars-Sinai Medical Center at 1 site in United States.
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 6 inclusion and 5 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: withdrawn, as of the sponsor's last update on 2 Mar 2015. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Postoperative Pain using VRS (time frame: 6 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 2 Mar 2015; AzTrials last refreshed its copy on 29 Oct 2026.