Trial Outcomes & Findings for Regional Anesthesia and Breast Cancer Recurrence (NCT NCT00418457)
NCT ID: NCT00418457
Last Updated: 2020-06-16
Results Overview
time to breast cancer recurrence from the end of surgery.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2108 participants
Primary outcome timeframe
up to 10 years
Results posted on
2020-06-16
Participant Flow
Participant milestones
| Measure |
General Anesthesia and Opioid
General anesthesia followed by opioid administration
General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia
|
Regional Analgesia and Propofol
Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
|
|---|---|---|
|
Overall Study
STARTED
|
1065
|
1043
|
|
Overall Study
COMPLETED
|
1065
|
1043
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Regional Anesthesia and Breast Cancer Recurrence
Baseline characteristics by cohort
| Measure |
General Anesthesia and Opioid
n=1065 Participants
General anesthesia followed by opioid administration
General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia
|
Regional Analgesia and Propofol
n=1043 Participants
Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
|
Total
n=2108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 11 • n=5 Participants
|
53 years
STANDARD_DEVIATION 12 • n=7 Participants
|
53 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1065 Participants
n=5 Participants
|
1043 Participants
n=7 Participants
|
2108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
989 Participants
n=5 Participants
|
972 Participants
n=7 Participants
|
1961 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
72 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 10 yearstime to breast cancer recurrence from the end of surgery.
Outcome measures
| Measure |
General Anesthesia and Opioid
n=1065 Participants
General anesthesia followed by opioid administration
General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia
|
Regional Analgesia and Propofol
n=1043 Participants
Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
|
|---|---|---|
|
Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery
|
111 participants
|
102 participants
|
SECONDARY outcome
Timeframe: 6 months and 1 yearPopulation: data was not available/collected for all participants due to lost follow up or miss phone call.
Brief Pain Inventory is used to evaluate with values of any pain vs. no pain (binary)
Outcome measures
| Measure |
General Anesthesia and Opioid
n=872 Participants
General anesthesia followed by opioid administration
General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia
|
Regional Analgesia and Propofol
n=856 Participants
Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
|
|---|---|---|
|
Number of Participants That Experienced Post-Surgical Pain
at 6-month
|
456 Participants
|
442 Participants
|
|
Number of Participants That Experienced Post-Surgical Pain
1-year
|
232 Participants
|
239 Participants
|
SECONDARY outcome
Timeframe: 6 month and 1 yearPopulation: data was not available/collected for all participants due to lost follow up or miss phone call.
neuropathic pain is a binary outcome: any pain vs. no pain
Outcome measures
| Measure |
General Anesthesia and Opioid
n=870 Participants
General anesthesia followed by opioid administration
General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia
|
Regional Analgesia and Propofol
n=859 Participants
Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
|
|---|---|---|
|
Number of Participants That Experienced Neuropathic Pain After Surgery
at 6-month
|
89 Participants
|
87 Participants
|
|
Number of Participants That Experienced Neuropathic Pain After Surgery
1-year
|
57 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: 6 month and 1 yearPopulation: data was not available/collected for all participants due to lost follow up or miss phone call.
Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
General Anesthesia and Opioid
n=804 Participants
General anesthesia followed by opioid administration
General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia
|
Regional Analgesia and Propofol
n=807 Participants
Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
|
|---|---|---|
|
SF-12 PCS Score
at 6-month
|
49.7 score on a scale
Standard Deviation 8.1
|
49.8 score on a scale
Standard Deviation 8.2
|
|
SF-12 PCS Score
1-year
|
52.3 score on a scale
Standard Deviation 6.7
|
52.1 score on a scale
Standard Deviation 7.3
|
SECONDARY outcome
Timeframe: 6 month and 1 yearPopulation: data was not available/collected for all participants due to lost follow up or miss phone call.
Physical and Mental Health Composite Scores (PCS \& MCS) are computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.
Outcome measures
| Measure |
General Anesthesia and Opioid
n=804 Participants
General anesthesia followed by opioid administration
General anesthesia and opioids: General anesthesia, usually with sevoflurane, and opioid analgesia
|
Regional Analgesia and Propofol
n=807 Participants
Regional anesthesia and analgesia (either epidural or paravertebral) combined with propofol
Regional analgesia and propofol: Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia
|
|---|---|---|
|
SF-12 MCS Score
at 6-month
|
48.1 units on a scale
Standard Deviation 8.6
|
48.7 units on a scale
Standard Deviation 8.1
|
|
SF-12 MCS Score
1-year
|
48 units on a scale
Standard Deviation 9.7
|
48.7 units on a scale
Standard Deviation 9.4
|
Adverse Events
General Anesthesia and Opioid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
Regional Analgesia and Propofol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 18 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place