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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ropivacaine + dexamethasone | Active Comparator | 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 | Placebo Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Analgesic Dose | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Melton, MD | Duke University | Principal Investigator |
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Because the required sample size of 60 subjects was not met, the study was terminated. Five subjects were enrolled from April 2012 to September 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous (IV) Control Group | 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 |
| FG001 | Local Anesthetic (LA) Control Group | 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 + Placebo |
| FG002 | Additive Group | 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 + Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous (IV) Control Group | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to First Analgesic Dose | one subject in the Local Anesthetic (LA) Control Group was not analyzed because subject did not return the data sheet | Posted | Mean | Standard Deviation | hours | 48 hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous (IV) Control Group | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Melton, MD | Duke University | 919.668.2047 | steve.melton@duke.edu |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Dexamethasone | Drug |
|
| Placebo | Other |
|
| Local Anesthetic (LA) Control Group |
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 + Placebo |
| BG002 | Additive Group | 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 + Placebo |
| BG003 | Total | Total of all reporting groups |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Additive Group | 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 + Placebo |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Local Anesthetic (LA) Control Group | 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 + Placebo | 0 | 2 | 0 | 2 |
| EG002 | Additive Group | 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 + Placebo | 0 | 1 | 0 | 1 |
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| D000588 |
| Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |