Dexamethasone and Analgesic Duration After Supraclavicula... | NCT00802009

Studies
Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade

NCT00802009

Sponsor

University Health Network, Toronto

Status

Completed

Last Update Posted

Jan 26, 2010Estimated

Enrollment

44Estimated

Phase

Not Applicable

Conditions

Anesthesia

Interventions

Dexamethasone
Mepivicaine

Countries

Canada

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

Jan 2010

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

May 2009

Primary Completion Date

Oct 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Dec 2, 2008

First Submission Date that Met QC Criteria

Dec 3, 2008

First Posted Date

Dec 4, 2008Estimated

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

Jan 22, 2010

Last Update Posted Date

Jan 26, 2010Estimated

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

Patients undergoing surgery of the hand often are treated with a nerve block in the shoulder/neck area that provides anesthesia/numbing during surgery. Nerve blocks usually last for a few hours after surgery and provide pain relief for this period. It may be possible to extend the duration of anesthesia by using a steroid, which has anti-inflammtory properties. This study will compare the duration of the nerve block when dexamethasone (steroid) is added to the anesthetic injected around the nerve.

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Dexamethasone 8mg added to routine local anesthetic during brachial plexus blockade.	Drug: Dexamethasone Drug: Mepivicaine
2	Active Comparator	Routine anesthetic solution (30 cc 1.5% mepivicaine) used during brachial plexus blockade.	Drug: Mepivicaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Dexamethasone 8 milligrams (liquid) will be added to standard anesthetic solution administered during routine brachial plexus nerve blockade.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Duration of anesthesia		hourly for first 24 hours; daily until discharge

Secondary Outcomes

Measure	Description	Time Frame
Requirements for pain medications; complications		up to 3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients having unilateral hand or forearm surgery under Supraclavicular brachial plexus blockade.
ASA I-III
Age 18-60
BMI < 35

Exclusion Criteria:

Patients with a known history of hypersensitivity to local anesthetics and dexamethasone.
Contra-indication to regional anesthesia/ supraclavicular brachial plexus blockade e.g. bleeding diathesis, coagulopathy.
Peripheral neuropathy.
Peptic ulcer disease.
Diabetes Mellitus.
Inability to give informed consent.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Toronto Western Hospital, University Health Network		Toronto	Ontario	M6G 2N6	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

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Browse Branches

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