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Patients scheduled to go home after ankle surgery at HSS typically receive a sciatic nerve block in the popliteal fossa and oral analgesic tablets (such as Percocet). Popliteal fossa nerve blockade has reduced pain for these patients (YaDeau et al, Anesth Analg 2008;106:1916-20), but unfortunately the patients still often experience moderate to severe pain after the block wears off. The investigators wish to study two additives that may prolong the period of analgesia provided by the nerve block. The additives will be studied in the context of a standardized postoperative multimodal analgesic pathway.
Primary outcome:
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Nerve Block. IV Dexamethasone (4 mg). | Experimental | Control Nerve Block. IV Dexamethasone (4 mg). |
|
| Nerve Block with Dexamethasone (4 mg). IV saline. | Experimental | B. Nerve Block with Dexamethasone (4 mg). IV saline. |
|
| Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | Experimental | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) |
|
| Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone ( | Experimental | Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). |
|
| Nerve Block with Dexamethasone (4 mg) / block Buprenorphine | Experimental | Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A. Control Nerve Block. IV Dexamethasone (4 mg). | Drug | A. Control Nerve Block. IV Dexamethasone (4 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time it Takes for Nerve Block to Wear Off | Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block? | up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Urban | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Nerve Block. IV Dexamethasone (4 mg). | Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg). |
| FG001 | Nerve Block With Dexamethasone (4 mg). IV Saline. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| B. Nerve Block with Dexamethasone (4 mg). IV saline. | Drug | B. Nerve Block with Dexamethasone (4 mg). IV saline. |
|
| C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) | Drug | C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) |
|
| D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). | Drug | D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). |
|
| E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). | Drug | E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. |
|
B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline. |
| FG002 | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) |
| FG003 | Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). |
| FG004 | Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Nerve Block. IV Dexamethasone (4 mg). | Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg). |
| BG001 | Nerve Block With Dexamethasone (4 mg). IV Saline. | B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline. |
| BG002 | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) |
| BG003 | Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). |
| BG004 | Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | 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 | Time it Takes for Nerve Block to Wear Off | Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block? | Posted | Mean | Standard Deviation | hours | up to 72 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 | Control Nerve Block. IV Dexamethasone (4 mg). | Control Nerve Block. IV Dexamethasone (4 mg). A. Control Nerve Block. IV Dexamethasone (4 mg).: A. Control Nerve Block. IV Dexamethasone (4 mg). | 0 | 17 | 0 | 17 | ||
| EG001 | Nerve Block With Dexamethasone (4 mg). IV Saline. | B. Nerve Block with Dexamethasone (4 mg). IV saline. B. Nerve Block with Dexamethasone (4 mg). IV saline.: B. Nerve Block with Dexamethasone (4 mg). IV saline. | 0 | 21 | 0 | 21 | ||
| EG002 | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg): C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg) | 0 | 19 | 0 | 19 | ||
| EG003 | Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).: D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg). | 0 | 19 | 0 | 19 | ||
| EG004 | Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).: E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline. | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yadeau | HSS | 212.606.1206 | YadeauJ@hss.edu |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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