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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine 0.25% mixed with 1ml normal saline | Placebo Comparator | Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) |
|
| Bupivacaine 0.25% with 1mg dexamethasone (1ml) | Active Comparator | Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) |
|
| Bupivacaine 0.25% mixed with 2mg dexamethasone | Active Comparator | Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) |
|
| Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml | Active Comparator | Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine 0.25% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Variable is Post Operative Sensory Block Duration | This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias. | days 1, 2, and day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Outcome Variable is Post Operative Motor Block Duration | This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiabin Liu, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19139 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine 0.25% Mixed With 1ml Normal Saline | Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo |
| FG001 | Bupivacaine 0.25% With 1mg Dexamethasone (1ml) | Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone |
| FG002 | Bupivacaine 0.25% Mixed With 2mg Dexamethasone | Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone |
| FG003 | Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml | Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bupivacaine 0.25% Mixed With 1ml Normal Saline | Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo |
| BG001 | Bupivacaine 0.25% With 1mg Dexamethasone (1ml) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Primary Outcome Variable is Post Operative Sensory Block Duration | This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias. | Posted | Mean | Inter-Quartile Range | hours | days 1, 2, and day 7 |
|
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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 | Bupivacaine 0.25% Mixed With 1ml Normal Saline | Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group) Bupivacaine 0.25% normal saline: placebo |
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First, all information was collected via telephone call during the recovery period at home, during which recall may be inaccurate. Second, we did not control the intravenous dexamethasone use, which could potentially affect the analgesia duration.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiabin Liu, MD, PhD | the University of Pennsylvania | 215-573-8208 | jiabin.liu@uphs.upenn.edu |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Dexamethasone | Drug |
|
| normal saline | Drug | placebo |
|
| days 1, 2, and day 7 |
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
Bupivacaine 0.25%
Dexamethasone
| BG002 | Bupivacaine 0.25% Mixed With 2mg Dexamethasone | Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone |
| BG003 | Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml | Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone |
| OG002 | Bupivacaine 0.25% Mixed With 2mg Dexamethasone | Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone |
| OG003 | Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml | Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone |
|
|
| Secondary | The Secondary Outcome Variable is Post Operative Motor Block Duration | This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias. | Posted | Mean | Inter-Quartile Range | hours | days 1, 2, and day 7 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Bupivacaine 0.25% With 1mg Dexamethasone (1ml) | Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone | 0 | 20 | 0 | 20 |
| EG002 | Bupivacaine 0.25% Mixed With 2mg Dexamethasone | Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml) Bupivacaine 0.25% Dexamethasone | 0 | 22 | 0 | 22 |
| EG003 | Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml | Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml Bupivacaine 0.25% Dexamethasone | 0 | 24 | 0 | 24 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |