Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00802009

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: Dexamethasone Drug: Mepivicaine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Duration of anesthesia [hourly for first 24 hours; daily until discharge]

Secondary Outcome Measures

Requirements for pain medications; complications [up to 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.