CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,108 enrolled
Drug / intervention
General anesthesia and opioids +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00418457
NCT00418457Phase 3Completed
CompareCT.gov

Regional Anesthesia and Breast Cancer Recurrence

The Cleveland Clinic·interventional·Posted Jan 4, 2007·Updated Jun 16, 2020

In Brief

A Phase 3 clinical trial evaluating General anesthesia and opioids and Regional analgesia and propofol for Breast Neoplasms. Completed, enrolled 2,108 participants across 6 sites in 6 countries.

Detailed Summary

In this multi-center trial, Stage 1-3 patients having mastectomies or isolated lumpectomy with axillary node dissection will be randomly assigned to thoracic epidural or paravertebral anesthesia/analgesia, or to general anesthesia and morphine analgesia. Participants will be followed for up to 10 years to determine the rate of cancer recurrence or metastasis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesAustria, China, Germany, Ireland, Singapore, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 4, 2007
Enrollment StartJan 1, 2007
Primary CompletionFeb 1, 2018
Study CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 11.1 yearsPosted 19.5 years ago

Interventions

General anesthesia and opioidsdrug

General anesthesia, usually with sevoflurane, and opioid analgesia

Regional analgesia and propofoldrug

Regional anesthesia and analgesia (either epidural or paravertebral), combined with deep sedation or general anesthesia