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This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.
This is a randomized study which will compare three femoral nerve catheter insertion techniques. Subjects will be randomized into one of thee groups, Group 1: ultrasound guided femoral nerve catheter using a stimulation needle and stimulating catheter, .Group 2: ultrasound guided femoral nerve catheter using a stimulation needle, but non-stimulating catheter, or Group 3: ultrasound guided femoral nerve block without stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound guidance alone | Active Comparator | The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. |
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| Ultrasound guidance needle stimulation | Active Comparator | For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation |
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| Ultrasound guidance+catheter stimulation | Active Comparator | For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound guidance alone | Procedure | The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. |
| Measure | Description | Time Frame |
|---|---|---|
| Time Weighted Average Verbal Response Scale Pain Score | Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable). Verbal Response Scale (VRS) pain scores after surgery - which ranged from 0 (no pain) to 10 (maximum intolerable pain) - were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.). | 48 hours after surgery |
| Opioid Consumption | cumulative opioid consumption, where all opioids were converted to IV morphine equivalents | 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Block Performance Time | Block performance time, defined as the time from block start until catheter placement. | time elapsed from beginning the block to catheter placement |
| Incremental Cost of Femoral Nerve Blocks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ehab Farag, M.D. | The Cleveland Clinic | Principal Investigator |
| Daniel I Sessler, M.D. | The Cleveland Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ultrasound Guidance Alone | The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. |
| FG001 | Ultrasound Guidance Needle Stimulation | For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation. |
| FG002 | Ultrasound Guidance+Catheter Stimulation | For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ultrasound Guidance Alone | The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Time Weighted Average Verbal Response Scale Pain Score | Time weighted average of verbal response scale (VRS) pain score on a scale from 0 (no pain) to 10 (worst pain imaginable). Verbal Response Scale (VRS) pain scores after surgery - which ranged from 0 (no pain) to 10 (maximum intolerable pain) - were assessed every 30 minutes in the recovery area and every 4 hours thereafter up to 48 hours postoperatively. These individual measurements were averaged for each patient using a time-weighted formula. (For a given patient, the observed VRS pain score profile as a function of time was linearly interpolated and integrated using the trapezoidal rule; then, the time-weighted average was calculated as the value of this integral divided by the total monitoring time of 48 hours.). | Posted | Mean | Standard Deviation | units on a scale | 48 hours after 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 | Ultrasound Guidance Alone | The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberta Johnson | Cleveland Clinic | 216-444-9950 | johnsor13@ccf.org |
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|
| ultrasound guidance and needle stimulation | Procedure | For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation. |
|
| ultrasound guidance and catheter stimulation | Procedure | The Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA. |
|
The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate.
| postoperative period when block is used |
| equipment failure |
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| ineligible post randomization |
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| cancellation of surgery |
|
| BG001 | Ultrasound Guidance Needle Stimulation | For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation. |
| BG002 | Ultrasound Guidance+Catheter Stimulation | For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Ultrasound Guidance Needle Stimulation | For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation. |
| OG002 | Ultrasound Guidance+Catheter Stimulation | For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA. |
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| Primary | Opioid Consumption | cumulative opioid consumption, where all opioids were converted to IV morphine equivalents | Posted | Median | Inter-Quartile Range | mg morphine equivalents | 48 hours after surgery |
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|
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| Secondary | Block Performance Time | Block performance time, defined as the time from block start until catheter placement. | Posted | Mean | 95% Confidence Interval | seconds | time elapsed from beginning the block to catheter placement |
|
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|
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| Secondary | Incremental Cost of Femoral Nerve Blocks | The incremental cost between strategies was calculated as the additional cost of one strategy to the next less costly strategy. There was no variance in the price because these prices were contracted with the hospital. The contracted price for a hospital does not change or fluctuate. | Posted | Mean | Standard Deviation | dollars | postoperative period when block is used |
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|
|
|
| 0 |
| 147 |
| 0 |
| 147 |
| EG001 | Ultrasound Guidance Needle Stimulation | For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation. | 0 | 152 | 0 | 152 |
| EG002 | Ultrasound Guidance+Catheter Stimulation | For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA. | 0 | 138 | 0 | 138 |
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| The primary analysis for opioid was a linear regression model comparing stimulating needle to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours. | t-test, 2 sided | 0.002 | Significance criterion of 0.00347 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons. | Mean Difference (Final Values) | -5 | 2-Sided | 95 | -25 | 21 | Non-Inferiority or Equivalence | Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean stimulating catheter is greater than 0.5 points). |
| The primary analysis for opioid was a linear regression model comparing stimulating catheter to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours. | t-test, 2 sided | 0.03 | Significance criterion of 0.01735 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons. | Mean Difference (Final Values) | 3 | 2-Sided | 95 | -25 | 21 | Non-Inferiority or Equivalence | Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating catheter minus mean ultrasound alone is greater than 0.5 points). |
| The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating catheter on the log of cumulative opioid consumption score for a patient in the first 48 hours. | t-test, 2 sided | 0.005 | Significance criterion of 0.00694 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons. | Mean Difference (Final Values) | -3 | 2-Sided | 95 | -24 | 23 | Non-Inferiority or Equivalence | Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating catheter is greater than 0.5 points). |
| The primary analysis for opioid was a linear regression model comparing stimulating needle to ultrasound alone on the log of cumulative opioid consumption score for a patient in the first 48 hours. | t-test, 2 sided | 0.006 | Significance criterion of 0.01041 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons. | Mean Difference (Final Values) | -2 | 2-Sided | 95 | -22 | 25 | Non-Inferiority or Equivalence | Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean stimulating needle minus mean ultrasound alone is greater than 0.5 points). |
| The primary analysis for opioid was a linear regression model comparing ultrasound alone to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours. | t-test, 2 sided | 0.02 | Significance criterion of 0.01388 after adjusting for group sequential design and applying Holm Bonferroni procedure to account for multiple comparisons. | Mean Difference (Final Values) | 2 | 2-Sided | 95 | -20 | 29 | Non-Inferiority or Equivalence | Noninferiority analysis used the 0.5-point noninferiority delta in a 1-tailed test of the treatment effect regression parameter (i.e., testing the null hypothesis that mean ultrasound alone minus mean stimulating needle is greater than 0.5 points). |
| 0.01 |
| Mean Difference (Final Values) |
| 40 |
| 2-Sided |
| 95 |
| 6 |
| 75 |
| Superiority or Other |
| Stimulating catheter versus ultrasound guidance alone | ANOVA | < 0.001 | Mean Difference (Final Values) | 67 | 2-Sided | 95 | 31 | 102 | Superiority or Other |
We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy. |
| incremental cost, measured in dollars |
| 36 |
| 2-Sided |
We estimated incremental cost, or additional cost of stimulating needle + catheter stimulation to stimulating needle alone. |
| Superiority or Other |
| We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy. | incremental cost, measured in dollars | 50 | 2-Sided | We calculated incremental cost, or the additional cost of stimulating needle + stimulating catheter to ultrasound alone. | Superiority or Other |