Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery

Duke University

Status and phase: Terminated; Phase 2

Conditions: Surgery, Hand

Treatments: Drug: Ropivacaine; Drug: Dexamethasone; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02154048

Pro00019301

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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5 participants in 3 patient groups, including a placebo group

ropivacaine + dexamethasone

Active Comparator group

Description:

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.

Treatment:

Drug: Ropivacaine

Drug: Dexamethasone

ropivacaine + placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Drug: Ropivacaine

ropivacaine + dexamethasone + placebo

Active Comparator group

Description:

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.

Treatment:

Other: Placebo

Drug: Ropivacaine

Drug: Dexamethasone