Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-09-30

Brief Summary

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The purpose of this study is to determine whether the addition of dexamethasone prolongs analgesia when added to long-acting local anesthetic during single-injection supraclavicular block for outpatient hand surgery.

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Detailed Description

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The goal for pain control after surgery is to provide the best possible pain control for the longest period of time with the least amount of side effects. One type of pain medication is called local anesthetic, which is a numbing medication that is injected in the area surrounding nerves to block pain. This injection is called a nerve block. Ropivacaine is a local anesthetic that is commonly used for nerve blocks and will be used in this study. The effects of ropivacaine may last for 8 to 12 hours after surgery. Recent research studies have shown that adding a medication called dexamethasone (a steroid) may increase the time that the nerve block will provide pain control. The purpose of this study is to see if adding dexamethasone to ropivacaine and injecting this around the nerves during a supraclavicular brachial plexus block increases the duration of pain relief as compared to both placebo control and systemic control groups.

Conditions

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Surgery, Hand

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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ropivacaine + dexamethasone

This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

ropivacaine + placebo

This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.

Group Type PLACEBO_COMPARATOR

Ropivacaine

Intervention Type DRUG

Placebo

Intervention Type OTHER

ropivacaine + dexamethasone + placebo

This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Placebo

Intervention Type OTHER

Interventions

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Ropivacaine

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Placebo

Intervention Type OTHER

Other Intervention Names

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Naropin

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years of age and older
* Patients scheduled for elective outpatient hand surgery with same day discharge at the Duke Ambulatory Surgery Center

Exclusion Criteria

* Patients who refuse regional anesthesia
* Patients in whom peripheral nerve block is contraindicated
* Patients unable to sign/understand consent
* Patients with significant language barriers who cannot comply with data collection process
* Patients with known allergies to local anesthetics
* Pregnancy
* Chronic pain patients or patients requiring chronic opioid treatment
* Patients with a history of diabetes
* Patients with contraindication to steroid administration (allergy, chronic steroid use)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No