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The duration of motor block for infragluteal parabiceps sciatic nerve block following total knee replacement may vary between 12-36 hrs depending on the amount of local anesthetic given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Active Comparator | Varying does to determine duration of analgesia following a sciatic nerve block |
|
| Ropivacaine | Active Comparator | Varying does to determine duration of analgesia following a sciatic nerve block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Varying doses to determine the duration of analgesia |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL | Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL). | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative Probabilities for Needle Positioning Above and Below CIEL. | The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated. |
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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, Feingberg School of Medicine | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24108248 | Derived | Nader A, Kendall MC, De Oliveira GS Jr, Puri L, Tureanu L, Brodskaia A, Asher Y, Parimi V, McCarthy RJ. A dose-ranging study of 0.5% bupivacaine or ropivacaine on the success and duration of the ultrasound-guided, nerve-stimulator-assisted sciatic nerve block: a double-blind, randomized clinical trial. Reg Anesth Pain Med. 2013 Nov-Dec;38(6):492-502. doi: 10.1097/AAP.0b013e3182a4bddf. |
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Exclusion criteria: subject refusal to be included in the study, contraindications to regional anesthesia, inability to elicit an evoked motor response less than or equal to 1 mA, history of allergy to amide local anesthetics, presence of a progressive neurological deficit, opioid tolerant subjects, presence of coagulopathy, infection, or pregnancy
Subjects undergoing primary tricompartmental total knee replacement at Northwestern Memorial Hospital were asked to participate. 174 patients were approached. 142 subjects were recruited to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bupivacaine | Varying does to determine duration of analgesia following a sciatic nerve block Bupivacaine : Varying doses to determine the duration of analgesia |
| FG001 | Ropivacaine | Varying does to determine duration of analgesia following a sciatic nerve block Ropivacaine : Varying doses to determine the duration of analgesia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GROUP 1 | Varying does to determine duration of analgesia following a sciatic nerve block Bupivacaine : Varying doses to determine the duration of analgesia |
| BG001 | GROUP 2 | Varying does to determine duration of analgesia following a sciatic nerve block Ropivacaine : Varying doses to determine the duration of analgesia |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Cumulative Probabilities for Needle Positioning Above and Below CIEL. | The cumulative probability distributions for the minimal current to evoke a motor response with the needle tip positioned external (above) to the common investing extraneural layer (CIEL) and the cumulative probability distribution for the needle tip postioned internal (below) to the CIEL were sought. The difference in the mean minimum threshold current (mA) for the external (above) and internal (below) CIEL positioning were calculated. | Posted | Mean | 95% Confidence Interval | Amplitude (mA) | 1 Day |
|
Time frame for adverse event reporting was 12 months following surgery.
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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 | GROUP 1 | Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml) |
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We used 5-mL increments of local anesthetic w/epinephrine between 5-30 mL which may have prevented from identifying more precisely the volume at which onset/duration were similar.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Kendall, M.D. | Northwestern University | 312-695-2528 | m-kendall@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 |
Varying doses to determine the duration of analgesia |
|
| 1 Day |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
|
|
|
| Primary | Duration of Motor and Sensory Block of the Sciatic With 0.5% Bupivacaine and Ropivacaine After Ultrasound-guided Nerve-stimulator-Assisted Needle Positioning Beneath the CIEL | Subject reported and investigator measured motor and sensory blockade of the sciatic nerve with less than 10ml of 0.5% bupivacaine and ropivacaine after ultrasound-guided nerve-stimulator-assisted needle positioning beneath the common investing external layer (CIEL). | Posted | Median | 95% Confidence Interval | Hours | 3 days |
|
|
|
|
| 0 |
| 69 |
| 0 |
| 69 |
| EG001 | GROUP 2 | Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml) | 0 | 70 | 0 | 70 |
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| D000588 |
| Amines |
| Sensory: <10ml |
|
| Sensory: >/= 10ml |
|
| Superiority or Other |
| The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference. | Wilcoxon (Mann-Whitney) | 0.05 | Mean Difference (Final Values) | -11.00 | Standard Deviation | 0 | 2-Sided | 95 | -15.00 | -6.00 | Superiority or Other |
| The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference. | Wilcoxon (Mann-Whitney) | 0.05 | Mean Difference (Final Values) | -7.0 | Standard Deviation | 0 | 2-Sided | 95 | -10.00 | -4.00 | Superiority or Other |
| The sample selected for this study,70 per drug group (or 10 in each of the 7 groups), achieves 88% power to detect a minimal difference of 4 hours in duration at a significance level (α) of 0.05 and a standard deviation of 3 hours using Williams test. We chose a difference of 4 hours as this was the interval used for assessment in the postoperative period at night. We sought to detect a difference that was equal to 1 observation period difference. | Wilcoxon (Mann-Whitney) | 0.05 | Mean Difference (Final Values) | -6.00 | Standard Deviation | 0 | 2-Sided | 95 | -7.00 | -2.00 | Superiority or Other |