Dexamethasone and Analgesic Duration After Supraclavicular Brachial Plexus Blockade

NCT00802009 | Completed

• 1 other identifier: 08-0896-B
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

ultrasound-guided regional anesthesia; nerve block; brachial plexus; mepivicaine; dexamethasone; hand wrist surgery; duration; anesthetic duration following brachial plexus/nerve block for hand/wrist surgery

Outcome Measures

Primary Outcomes (1)

• Duration of anesthesia

  hourly for first 24 hours; daily until discharge

Secondary Outcomes (1)

• Requirements for pain medications; complications

  up to 3 months

Study Arms (2)

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

Dexamethasone DRUG

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

1

Mepivicaine DRUG

Standard anesthetic solution administered during routine brachial plexus nerve blockade.

1; 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital, University Health Network

Toronto, Ontario, M6G 2N6, Canada

Location

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 2, 2008
• First Posted: December 4, 2008
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

CA (1)