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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00802009
Other study ID # 08-0896-B
Secondary ID
Status Completed
Phase N/A
First received December 2, 2008
Last updated January 22, 2010
Start date May 2009
Est. completion date November 2009

Study information

Verified date January 2010
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Canadian REB
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date November 2009
Est. primary completion date October 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dexamethasone
Dexamethasone 8 milligrams (liquid) will be added to standard anesthetic solution administered during routine brachial plexus nerve blockade.
Mepivicaine
Standard anesthetic solution administered during routine brachial plexus nerve blockade.

Locations

Country Name City State
Canada Toronto Western Hospital, University Health Network Toronto Ontario

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Duration of anesthesia hourly for first 24 hours; daily until discharge No
Secondary Requirements for pain medications; complications up to 3 months No
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