Trial · NCT00418457
Regional Anesthesia and Breast Cancer Recurrence
NCT00418457, Phase 3, Completed, The Cleveland Clinic; results first posted 2020-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Regional Anesthesia and Breast Cancer Recurrence. Trials, record NCT00418457. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00418457
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Regional Anesthesia and Breast Cancer Recurrence
- NCT number
- NCT00418457
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,108 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Breast Neoplasms
- Interventions
- General anesthesia and opioids, Regional analgesia and propofol
- First posted
- 2007-01-04
- Last updated
- 2020-06-16
- Results first posted
- 2020-06-16
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery | up to 10 years | time to breast cancer recurrence from the end of surgery. |
| Secondary | Number of Participants That Experienced Post-Surgical Pain | 6 months and 1 year | Brief Pain Inventory is used to evaluate with values of any pain vs. no pain (binary) |
| Secondary | Number of Participants That Experienced Neuropathic Pain After Surgery | 6 month and 1 year | neuropathic pain is a binary outcome: any pain vs. no pain |
| Secondary | SF-12 PCS Score | 6 month and 1 year | 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. |
| Secondary | SF-12 MCS Score | 6 month and 1 year | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery | up to 10 years | participants | NUMBER | |
| SECONDARY | Number of Participants That Experienced Post-Surgical Pain | 6 months and 1 year | data was not available/collected for all participants due to lost follow up or miss phone call. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Experienced Neuropathic Pain After Surgery | 6 month and 1 year | data was not available/collected for all participants due to lost follow up or miss phone call. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | SF-12 PCS Score | 6 month and 1 year | data was not available/collected for all participants due to lost follow up or miss phone call. | score on a scale | MEAN |
| SECONDARY | SF-12 MCS Score | 6 month and 1 year | data was not available/collected for all participants due to lost follow up or miss phone call. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery | General Anesthesia and Opioid | 111 | participants | ||
| Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery | Regional Analgesia and Propofol | 102 | participants | ||
| Number of Participants That Experienced Post-Surgical Pain | General Anesthesia and Opioid | at 6-month | 456 | Participants | |
| Number of Participants That Experienced Post-Surgical Pain | Regional Analgesia and Propofol | at 6-month | 442 | Participants | |
| Number of Participants That Experienced Post-Surgical Pain | General Anesthesia and Opioid | 1-year | 232 | Participants | |
| Number of Participants That Experienced Post-Surgical Pain | Regional Analgesia and Propofol | 1-year | 239 | Participants | |
| Number of Participants That Experienced Neuropathic Pain After Surgery | General Anesthesia and Opioid | at 6-month | 89 | Participants | |
| Number of Participants That Experienced Neuropathic Pain After Surgery | Regional Analgesia and Propofol | at 6-month | 87 | Participants | |
| Number of Participants That Experienced Neuropathic Pain After Surgery | General Anesthesia and Opioid | 1-year | 57 | Participants | |
| Number of Participants That Experienced Neuropathic Pain After Surgery | Regional Analgesia and Propofol | 1-year | 57 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | General Anesthesia and Opioid | 1,065 | |
| Overall Study | STARTED | Regional Analgesia and Propofol | 1,043 | |
| Overall Study | COMPLETED | General Anesthesia and Opioid | 1,065 | |
| Overall Study | COMPLETED | Regional Analgesia and Propofol | 1,043 | |
| Overall Study | NOT COMPLETED | General Anesthesia and Opioid | 0 | |
| Overall Study | NOT COMPLETED | Regional Analgesia and Propofol | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | General Anesthesia and Opioid | 22 | 1,065 |
| Total, all-cause mortality | Regional Analgesia and Propofol | 18 | 1,043 |
| Total, other adverse events | General Anesthesia and Opioid | 0 | 1,065 |
| Total, other adverse events | Regional Analgesia and Propofol | 0 | 1,043 |
| Total, serious adverse events | General Anesthesia and Opioid | 0 | 1,065 |
| Total, serious adverse events | Regional Analgesia and Propofol | 0 | 1,043 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| General Anesthesia and Opioid vs Regional Analgesia and Propofol: Number of Participants Who Had Breast Cancer Recurrence After Breast Cancer Surgery | Trial comparisons |
| General Anesthesia and Opioid vs Regional Analgesia and Propofol: deaths from any cause | Trial comparisons |
| General Anesthesia and Opioid vs Regional Analgesia and Propofol: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00418457
GET https://conductscience.org/api/trials/v1/NCT00418457/registered