Paravertebral Block for Breast Surgery | NCT00131170

Studies
Paravertebral Block for Breast Surgery

NCT00131170

Sponsor

University of Aarhus

Status

Completed

Last Update Posted

Jul 6, 2007Estimated

Enrollment

90Actual

Phase

Phase 4

Conditions

Breast Cancer

Interventions

paravertebral block

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Not provided

Completion Date

Sep 2006Actual

First Submitted Date

Aug 15, 2005

First Submission Date that Met QC Criteria

Aug 15, 2005

First Posted Date

Aug 17, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 4, 2007

Last Update Posted Date

Jul 6, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain ([VAS] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Name	Type	Description	Arm Group Labels	Other Names
paravertebral block	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively		2 days

Secondary Outcomes

Measure	Description	Time Frame
Dosage of analgesic		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Breast surgery

Exclusion Criteria:

Infections
Coagulation disorder
Allergy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Palle Carlsson, MD Dr Sci	Dept anesthesiology, Arhus University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept of Anesthesiology, Aarhus University Hospital		Aarhus		DK 8000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided