Mastectomy, Modified RadicalNCT02747992
Paravertebral Block (PVB) Combined Pectoral Musculature Blocks for Modified Radical Mastectomy (MRM)
An observational study of Mastectomy, Modified Radical, run by Sun Yat-sen University.
Trial summary
Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature. Read more about this study
- Who is it for?
- Ages 20 to 75 years, women only
- Conditions the study is for
- Mastectomy, Modified Radical
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Feb 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 20 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients were that diagnosed to have unilateral breast cancer and undergone modified radical mastectomy using regional anesthesia during Jun 1, 2012 and May 31, 2015.
Who may be able to join
- The American Society of Anesthesiologists (ASA) Physical Status classification I to III
- 20 - 75 years of age
- female gender
Who cannot join
- body mass index (BMI) ≥ 35 kg/m2
- modified radical mastectomy not performed by the single surgeon (Ben Long Yu)
- anesthesia not performed by the single anesthesiologist (Nai Liang Li)
About this study
Official title: Comparisons the Analgesia of Paravertebral Block Combined With Thoracic Wall Block Versus Paravertebral Block Alone for Modified Radical Mastectomy in Breast Cancer
Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.
- Conditions
- Mastectomy, Modified Radical
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 |
|---|---|---|
| PECS 0 | receiving paravertebral block | |
| PECS 1 | receiving paravertebral block and blocks targeting pectoral musculature |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative sedation requirement
target controlled infusion (TCI) propofol driven by the Schnider model in effect site control titrated to reach conscious sedation defined as Observer Assessment of Alertness/Sedation score of 2 to 3
Measured: during operation
Secondary outcomes (3)
time to first request of analgesics
Measured: postoperative 12 hours
postoperative analgesic requirement
Measured: postoperation to discharge
side effects
Measured: postoperation to within 24 hours after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mastectomy, Modified RadicalStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nai Liang Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747992
- Sponsor's protocol ID
- PVBPEC
- Status last verified
- Apr 2016
- First submitted
- 17 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons the Analgesia of Paravertebral Block Combined With Thoracic Wall Block Versus Paravertebral Block Alone for Modified Radical Mastectomy in Breast Cancer
- ClinicalTrials.gov ID
- NCT02747992
- Acronym / sponsor ID
- PVBPEC
- Conditions
- Mastectomy, Modified Radical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- First posted
- 22 Apr 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.
Previous studies have shown that PVB reduces pain and postoperative nausea and vomiting after breast cancer surgery when used in addition to general anesthesia or sedation. However, major breast cancer surgery involves areas beyond the breast tissue, such as pectoral musculature.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PECS 0 | – | –receiving paravertebral block |
| PECS 1 | – | –receiving paravertebral block and blocks targeting pectoral musculature |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients were that diagnosed to have unilateral breast cancer and undergone modified radical mastectomy using regional anesthesia during Jun 1, 2012 and May 31, 2015.
Key inclusion criteria (3 listed)
- The American Society of Anesthesiologists (ASA) Physical Status classification I to III
- 20 - 75 years of age
- female gender
Key exclusion criteria (3 listed)
- body mass index (BMI) ≥ 35 kg/m2
- modified radical mastectomy not performed by the single surgeon (Ben Long Yu)
- anesthesia not performed by the single anesthesiologist (Nai Liang Li)
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
intraoperative sedation requirement
Time frame: during operation
target controlled infusion (TCI) propofol driven by the Schnider model in effect site control titrated to reach conscious sedation defined as Observer Assessment of Alertness/Sedation score of 2 to 3
3 secondary outcomes
time to first request of analgesics
Time frame: postoperative 12 hours
postoperative analgesic requirement
Time frame: postoperation to discharge
side effects
Time frame: postoperation to within 24 hours after discharge
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 22 Apr 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.
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 Mastectomy, Modified Radical, run by Sun Yat-sen 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 3 inclusion and 3 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 22 Apr 2016. 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?
intraoperative sedation requirement (time frame: during operation). 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 22 Apr 2016.