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This study will look at the efficacy of dexamethasone for prolongation of peripheral nerve blocks.
The purpose of this randomized, double-blinded, placebo-controlled trial is to examine if dexamethasone given perineurally as an adjuvant to the nerve block will prolong the time to recovery from sensory nerve block from a saphenous (or adductor canal) nerve block. The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. If this primary end point is met, this study will also serve as an equivalency dosing study comparing 1 mg of perineural dexamethasone to 4 mg of perineural dexamethasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 mg Perineural Dexamethasone Group | Experimental | 4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. |
|
| 1 mg Perineural Dexamethasone Group | Experimental | 1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. |
|
| Placebo Group | Placebo Comparator | This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Used in nerve block mixture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Sensory Nerve Block | The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours. | 12 to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Pain Scores | Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours. | 0 to 30 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daryl S Henshaw, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29753264 | Derived | Turner JD, Henshaw DS, Weller RS, Jaffe JD, Edwards CJ, Reynolds JW, Russell GB, Dobson SW. Perineural dexamethasone successfully prolongs adductor canal block when assessed by objective pinprick sensory testing: A prospective, randomized, dose-dependent, placebo-controlled equivalency trial. J Clin Anesth. 2018 Aug;48:51-57. doi: 10.1016/j.jclinane.2018.05.009. Epub 2018 May 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 4 mg Perineural Dexamethasone Group | 4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Dexamethasone: Used in nerve block mixture Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
| FG001 | 1 mg Perineural Dexamethasone Group | 1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Dexamethasone: Used in nerve block mixture Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
| FG002 | Placebo Group | This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural. Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 4 mg Perineural Dexamethasone Group | 4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Dexamethasone: Used in nerve block mixture Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
| 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 | Duration of Sensory Nerve Block | The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours. | Posted | Mean | Standard Deviation | hours | 12 to 48 hours |
|
Adverse event data was collected for 72 hours post-operatively.
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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 | 4 mg Perineural Dexamethasone Group | 4 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Dexamethasone: Used in nerve block mixture Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jimmy Turner | Wake Forest Baptist Health | 3368064498 | jturner@wakehealth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 7, 2015 | Jul 10, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| C004180 | dexamethasone 21-phosphate |
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Bupivacaine | Drug | Used in nerve block mixture |
|
|
| Epinephrine | Drug | Used in nerve block mixture |
|
|
| Saphenous Peripheral Nerve Block | Procedure | Peripheral nerve block. |
|
|
| Rate of Post Operative Nausea and Vomiting | Number of participants that experienced nausea and vomiting was recorded. | 0 to 30 hours |
| Neurologic Complications | Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur. | throughout study completion, up to 48 hours |
| Post Operative Opioid Use and Consumption | Amount of opioid use and consumption was recorded. | 0-30 hours |
| Time to First Opioid Analgesic Request | Time it took for the first opioid analgesic request was recorded. | 0 to 36 hours |
| BG001 | 1 mg Perineural Dexamethasone Group | 1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Dexamethasone: Used in nerve block mixture Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
| BG002 | Placebo Group | This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural. Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given.
Dexamethasone: Used in nerve block mixture
Bupivacaine: Used in nerve block mixture
Epinephrine: Used in nerve block mixture
Saphenous Peripheral Nerve Block: Peripheral nerve block.
| OG002 | Placebo Group | This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural. Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. |
|
|
| Secondary | Verbal Pain Scores | Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours. | Posted | Mean | Standard Deviation | units on a scale | 0 to 30 hours |
|
|
|
| Secondary | Rate of Post Operative Nausea and Vomiting | Number of participants that experienced nausea and vomiting was recorded. | Posted | Count of Participants | Participants | 0 to 30 hours |
|
|
|
| Secondary | Neurologic Complications | Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur. | Posted | Mean | Standard Deviation | neurological complications | throughout study completion, up to 48 hours |
|
|
|
| Secondary | Post Operative Opioid Use and Consumption | Amount of opioid use and consumption was recorded. | Posted | Mean | Standard Deviation | mg oxycodone equivalents | 0-30 hours |
|
|
|
| Secondary | Time to First Opioid Analgesic Request | Time it took for the first opioid analgesic request was recorded. | Posted | Mean | Standard Deviation | minutes | 0 to 36 hours |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | 1 mg Perineural Dexamethasone Group | 1 mg of dexamethasone will be included in the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. No systemic dexamethasone will be given. Dexamethasone: Used in nerve block mixture Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. | 0 | 36 | 0 | 36 | 0 | 36 |
| EG002 | Placebo Group | This group will receive only the saphenous nerve block mixture including 20 ml of 0.25% bupivacaine with 1:400,000 epinephrine. Dexamethasone will not be administered to this group systemically or perineural. Bupivacaine: Used in nerve block mixture Epinephrine: Used in nerve block mixture Saphenous Peripheral Nerve Block: Peripheral nerve block. | 0 | 12 | 0 | 12 | 0 | 12 |
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| D012216 |
| Rheumatic Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
|
| 12h |
|
| 18h |
|
| 24h |
|
| 30h |
|