Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade

January 22, 2010 updated by: University Health Network, Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M6G 2N6
        • Toronto Western Hospital, University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Dexamethasone 8mg added to routine local anesthetic during brachial plexus blockade.
Drug: Dexamethasone
Dexamethasone 8 milligrams (liquid) will be added to standard anesthetic solution administered during routine brachial plexus nerve blockade.
Drug: Mepivicaine
Standard anesthetic solution administered during routine brachial plexus nerve blockade.
Active Comparator: 2
Routine anesthetic solution (30 cc 1.5% mepivicaine) used during brachial plexus blockade.
Drug: Mepivicaine
Standard anesthetic solution administered during routine brachial plexus nerve blockade.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

December 2, 2008

First Submitted That Met QC Criteria

December 3, 2008

First Posted (Estimate)

December 4, 2008

Study Record Updates

Last Update Posted (Estimate)

January 26, 2010

Last Update Submitted That Met QC Criteria

January 22, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-0896-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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