Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery

Phase 2

Terminated

Conditions: Surgery, Hand

Interventions: Drug: Ropivacaine
Other: Placebo
Drug: Dexamethasone

Registration Number: NCT02154048

Lead Sponsor: Duke University

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 5

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ropivacaine + dexamethasone + placebo	Ropivacaine	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.
ropivacaine + placebo	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.
ropivacaine + dexamethasone + placebo	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.
ropivacaine + dexamethasone	Ropivacaine	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.
ropivacaine + dexamethasone	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.
ropivacaine + placebo	Ropivacaine	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.
ropivacaine + dexamethasone + placebo	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 both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.