Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-02-28

Brief Summary

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When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic shoulder surgery. This study seeks to determine if there is a relationship between the duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP) when combined with increasing doses of dexamethasone.

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Detailed Description

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The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect on the duration of analgesia. Therefore, we are not considering any patients to receive suboptimal dosing of preservative free dexamethasone in this study.

Conditions

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Post Surgical Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Bupivacaine 0.25% mixed with 1ml normal saline

Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)

Group Type PLACEBO_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

normal saline

Intervention Type DRUG

placebo

Bupivacaine 0.25% with 1mg dexamethasone (1ml)

Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Bupivacaine 0.25% mixed with 2mg dexamethasone

Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml

Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml

Group Type ACTIVE_COMPARATOR

Bupivacaine 0.25%

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Interventions

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Bupivacaine 0.25%

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

normal saline

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already elected to receive and are eligible for regional anesthesia (brachial plexus nerve block) prior to consenting for study.
2. Ability to sign informed consent.
3. Ability to follow study protocol, and speak, read and write in English.
4. Must have valid phone number for follow-up purpose.
5. Must be able to receive all protocol medications to include the dexamethasone, ketorolac, hydromorphone, and percocet.

Exclusion Criteria

1. Patient younger than 18 years old and older than age 70
2. Patient refusal to sign consent
3. Chronic opioid use (defined as narcotic use longer than 3 months) as documented in patient's medical record
4. Allergy to any of the protocol medications
5. Patients with severe lung disease, contra lateral phrenic nerve injury, insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as documented in patient's medical record
6. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No