NCT00131170

Brief Summary

The effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P25-P50 for phase_4 breast-cancer

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 6, 2007

Status Verified

July 1, 2007

First QC Date

August 15, 2005

Last Update Submit

July 4, 2007

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively

    2 days

Secondary Outcomes (1)

  • Dosage of analgesic

    1 day

Interventions

paravertebral blockPROCEDURE

Eligibility Criteria

Age18 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Breast surgery

You may not qualify if:

  • Infections
  • Coagulation disorder
  • Allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology, Aarhus University Hospital

Aarhus, DK 8000, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Palle Carlsson, MD Dr Sci

    Dept anesthesiology, Arhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 17, 2005

Study Start

September 1, 2005

Study Completion

September 1, 2006

Last Updated

July 6, 2007

Record last verified: 2007-07

Locations

DK(1)