NCT00547989

Brief Summary

Aim is to study if a paravertebral block as an adjunct to general anesthesia is a suitable technique for extended, one sided, breast surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Oct 2006

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

Study Start

First participant enrolled

October 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

October 18, 2007

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

4.2 years

First QC Date

October 18, 2007

Last Update Submit

June 10, 2014

Conditions

Breast Cancer

Keywords

ASA class I and II

Outcome Measures

Primary Outcomes (1)

  • reduction of unplanned admissions and reduction of VAS score.

    one week

Secondary Outcomes (1)

  • to determine the safety and performance (efficacy) of the technique and the investigational product.

    one week

Study Arms (3)

1

ACTIVE COMPARATOR

control

Drug: standard anaesthesia (bupivacaine)

2

EXPERIMENTAL

PVB with ropivacaine and postoperative pump 5ml/h

Drug: additional pvb (ropivacaine) and elastomeric disposable infusion pump

Experimental 1

EXPERIMENTAL

PVB with ropivacaine, 10 patients included but not analysed

Drug: additional pvb (ropivacaine)

Interventions

standard anaesthesia (bupivacaine)DRUG

Local infiltration with bupivacaine and Piritramide and Paracetamol as postoperative analgesic, and ondansetron as required

1
additional pvb (ropivacaine) and elastomeric disposable infusion pumpDRUG

Patients in group 2 will receive PVB with ropivacaine and postoperative pump 5ml/h.

2
additional pvb (ropivacaine)DRUG

Patients in group 1 will receive PVB with ropivacaine

Experimental 1

Eligibility Criteria

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

You may qualify if:

  • Extended mamma surgery one-sided
  • ASA class I and II

You may not qualify if:

  • All contra indications for local anaesthesia
  • Coagulation disorders
  • Infection
  • Allergic reactions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Maastricht, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

BupivacaineRopivacaine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Esther Bouman, MD

    azM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2007

First Posted

October 23, 2007

Study Start

October 1, 2006

Primary Completion

December 1, 2010

Study Completion

May 1, 2011

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

NL(1)