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| ID | Type | Description | Link |
|---|---|---|---|
| STU00058306 |
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The study has been terminiated due to minimal subject recruitment
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The purpose of this study is to compare the incidence of postoperative symptoms of neurologic injury after a single shot infragluteal-parabiceps sciatic nerve block versus a continuous infragluteal-parabiceps sciatic nerve catheter.
There are a limited number of prospective studies in the literature examining the risk of neurologic injury and symptoms after sciatic nerve blocks. The incidence of transient neurological symptoms after a continuous catheter is not well reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Shot Sciatic Nerve Block | Active Comparator | Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml). |
|
| Continuous Sciatic Nerve Block | Active Comparator | Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Bupivacaine 0.625% with epinephrine 1:300,000 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Temporary Neurologic Symptoms Between Groups | Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Satisfaction With Anesthesia | Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied | 24 hours |
| Pain Control | Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoun Nader, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Single Shot Sciatic Nerve Block | Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml). Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000 |
| FG001 | Continuous Sciatic Nerve Block | Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves. Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Shot Sciatic Nerve Block | Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml). Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000 |
| 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 | Temporary Neurologic Symptoms Between Groups | Temporary neurologic symptoms between groups; muscle weakness of either foot dorsiflexion and plantar flexion | Posted | Number | percentage of total participants | 1 month |
|
4 weeks
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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 | Single Shot Sciatic Nerve Block | Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml). Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000 |
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Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antoun Nader | Northwestern University, Feinberg School of Medicine | 312-695-3045 | a-nader2@northwestern.edu |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine | Drug | 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. |
|
|
| 72 hrs |
| BG001 |
| Continuous Sciatic Nerve Block |
Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves. Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Participant Satisfaction With Anesthesia | Patient satisfaction on a 0 to 10 scale with 0 equals completely dissatisfied and 10 equals completely satisfied | Posted | Median | Inter-Quartile Range | units on a scale | 24 hours |
|
|
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| Secondary | Pain Control | Numeric rating score for pain (NRS) 0 to 10 scale where 0 equals no pain and 10 equals the worst pain imaginable | Posted | Median | Inter-Quartile Range | units on a scale | 72 hrs |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| EG001 | Continuous Sciatic Nerve Block | Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves. Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. | 0 | 4 | 0 | 4 |
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| D000588 |
| Amines |