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The purpose of this research study to evaluate the effects of dexamethasone as an addition to peripheral nerve block (Put the nerve to sleep with Bupivacaine a numbing medication) on length of pain relief (analgesia), postoperative narcotic (opioids) requirements, pain scores, and patient satisfaction after foot and ankle procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone group | Active Comparator | Dexamethasone 4mg(1 ml) per 20cc |
|
| Saline group | Placebo Comparator | Saline 1 ml per 20cc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain | Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) | 3 days |
| Length of Analgesia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roya Yumul, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical center | Los Angeles | California | 90048 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone Group | 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc |
| FG001 | Saline Group | 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone Group | 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc |
| BG001 | Saline Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Postoperative Pain | Postoperative pain will be measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No pain" and 10 indicates= The worst possible pain | Posted | Mean | Standard Deviation | Scores on a scale | 3 days |
|
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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 | Dexamethasone Group | 0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roya Yumul, M.D., Ph.D. | Department of Anesthesiology at Cedars-Sinai Medical Center in Los Angeles | 310-423-5841 | (Roya.Yumul@cshs.org) |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Saline | Drug | 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc |
|
|
Time in days and/or hours
| 3 days |
| Patient Satisfaction With Regional Nerve Block | Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied | 3 days |
| Patient Satisfaction With Pain Management | Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied | 3 days |
0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Opioid Consumption | Opioid consumption obtained from the recorded data Perioperative use of opioid consumption inside hospital (recorded by study staff and data obtained from patient charts) | Posted | Mean | Standard Deviation | Opioids consumption mg | 3 days |
|
|
|
| Secondary | Length of Analgesia | Time in days and/or hours | Posted | Median | Inter-Quartile Range | Hours | 3 days |
|
|
|
| Secondary | Patient Satisfaction With Regional Nerve Block | Patient satisfaction with regional nerve block: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied | Posted | Mean | Standard Deviation | Scores on a scale | 3 days |
|
|
|
| Secondary | Patient Satisfaction With Pain Management | Patient satisfaction with pain management: measured using a Verbal Rating Scale (0-10) Verbal Rating Scale: 0 to 10 scale where 0 indicates= No satisfied at all 10 indicates= Extremely satisfied | Posted | Mean | Standard Deviation | Scores on a scale | 3 days |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Saline Group | 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc | 0 | 28 | 0 | 28 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |