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Regional Anesthesia and Breast Cancer Recurrence

NCT00418457 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2108

Last updated 2020-06-16

Study results available
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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.

Conditions

  • Breast Neoplasms

Interventions

DRUG

General anesthesia and opioids

General anesthesia, usually with sevoflurane, and opioid analgesia

DRUG

Regional analgesia and propofol

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

Sponsors & Collaborators

  • The Cleveland Clinic

    lead OTHER

Principal Investigators

  • Daniel I Sessler, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2018-02-28
Completion
2019-12-31

Countries

  • United States
  • Austria
  • China
  • Germany
  • Ireland
  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00418457 on ClinicalTrials.gov