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This study looks at addition of medications to the local anesthetic for the nerve blockade.
Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also receive additional pain pills, including narcotics as needed. This study looks at addition of medications to the local anesthetic for the nerve blockade. The investigators hope that these medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve block. There are 3 groups in the study. One group is a control, and receives usual therapy: nerve block + pain pills. This is typically what the patient would receive as standard care if they were not in the study. One group uses a nerve block with additives (+ pain pills). One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or indirectly acts on the brain.
Patients will be followed while in the hospital, and contacted by telephone and/or email after discharge for 2-3 days. Patients will be asked about their pain levels and the duration of their block. The investigators will enroll 90 patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control NB + IV Dex + IV Bup | Active Comparator | IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) |
|
| Control NB + IV Dex | Active Comparator | IV Dexamethasone (4 mg) |
|
| NB with Dex + Bup in block. | Experimental | Dexamethasone (4 mg) Buprenorphine (150 mcg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score With Movement | Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) | 24 hours after the popliteal block is given |
| Measure | Description | Time Frame |
|---|---|---|
| Block Duration | When did the nerve block entirely wear off? | 24 hours and 48 hours after the popliteal block is given |
| Numeric Rating Scale (NRS) Pain Score at Rest | Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques YaDeau, MD, PhD | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25974277 | Derived | YaDeau JT, Paroli L, Fields KG, Kahn RL, LaSala VR, Jules-Elysee KM, Kim DH, Haskins SC, Hedden J, Goon A, Roberts MM, Levine DS. Addition of Dexamethasone and Buprenorphine to Bupivacaine Sciatic Nerve Block: A Randomized Controlled Trial. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):321-9. doi: 10.1097/AAP.0000000000000254. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Nerve Block + IV Dexamethasone | IV Dexamethasone (4 mg) Dexamethasone |
| FG001 | Control Nerve Block + IV Dexamethasone + IV Buprenorphine | IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine |
| FG002 | Nerve Block With Dexamethasone + Buprenorphine in Block. | Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Nerve Block + IV Dexamethasone | IV Dexamethasone (4 mg) Dexamethasone |
| BG001 | Control Nerve Block + IV Dexamethasone + IV Buprenorphine | IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine |
| 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 | Numeric Rating Scale (NRS) Pain Score With Movement | Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) | Posted | Mean | Standard Deviation | units on a scale | 24 hours after the popliteal block is given |
|
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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 | IV Dexamethasone (4 mg) Dexamethasone |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacques YaDeau | Hospital for Special Surgery | 212-606-1206 | yadeauj@hss.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 |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Buprenorphine |
| Drug |
|
| 24 hours after the popliteal block is given |
| Median Time to Requiring Oral Opioids | Did patient have pain requiring oral opioids? | 24 hours after the popliteal block is given |
| BG002 | Nerve Block With Dexamethasone + Buprenorphine in Block. | Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI (Body Mass Index) | Mean | Standard Deviation | kg/m^2 |
|
Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine |
|
|
| Secondary | Block Duration | When did the nerve block entirely wear off? | Posted | Median | 95% Confidence Interval | hours | 24 hours and 48 hours after the popliteal block is given |
|
|
|
| Secondary | Numeric Rating Scale (NRS) Pain Score at Rest | Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain) | Posted | Mean | Standard Error | units on a scale | 24 hours after the popliteal block is given |
|
|
|
| Secondary | Median Time to Requiring Oral Opioids | Did patient have pain requiring oral opioids? | Posted | Median | 95% Confidence Interval | hours | 24 hours after the popliteal block is given |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Control Nerve Block + IV Dexamethasone + IV Buprenorphine | IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg) Dexamethasone Buprenorphine | 0 | 30 | 0 | 30 |
| EG002 | Nerve Block With Dexamethasone + Buprenorphine in Block. | Dexamethasone (4 mg) Buprenorphine (150 mcg) Dexamethasone Buprenorphine | 0 | 30 | 0 | 30 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| 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 |