Total Knee Replacement Surgery
Conditions
Keywords
TKA, total knee replacement
Brief summary
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.
Detailed description
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. * Pain Scores after surgery with be measured using the VAS (Visual Analogue Scale). Subjects will be asked to rate their pain on a scale of 1-10. * Block Performance time is the time from starting the block (after prepping and draping) until catheter is placed. * Opioid requirements will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used both during surgery, and during the first 48 hours after surgery. * Block failure rate will be calculated as the rate of cases that requires repeating the block after surgery.
Interventions
PROCEDUREultrasound 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.
PROCEDUREultrasound 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.
PROCEDUREultrasound guidance and catheter stimulation
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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 80 years old at time of surgery. * Male or female patients undergoing total knee replacement under either general or neuraxial anesthesia (spinal or epidural). Intraoperative, patients will receive spinal anesthetics with 15 mg bupivacaine and 25mcg of fentanyl intrathecally.
Exclusion criteria
* Current or recent drug abuse (within past 6 months). * Pregnancy. * Patient refuses regional analgesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Weighted Average Verbal Response Scale Pain Score | 48 hours after surgery | 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.). |
| Opioid Consumption | 48 hours after surgery | cumulative opioid consumption, where all opioids were converted to IV morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Block Performance Time | time elapsed from beginning the block to catheter placement | Block performance time, defined as the time from block start until catheter placement. |
| Incremental Cost of Femoral Nerve Blocks | postoperative period when block is used | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 147 |
| 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. | 152 |
| 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. | 138 |
| Total | 437 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | cancellation of surgery | 0 | 1 | 2 |
| Overall Study | enrollment in another study | 1 | 1 | 2 |
| Overall Study | equipment failure | 1 | 0 | 0 |
| Overall Study | ineligible post randomization | 0 | 3 | 1 |
| Overall Study | Lost to Follow-up | 4 | 0 | 0 |
Baseline characteristics
| Characteristic | Ultrasound Guidance Alone | Ultrasound Guidance Needle Stimulation | Ultrasound Guidance+Catheter Stimulation | Total |
|---|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 9 | 61 years STANDARD_DEVIATION 13 | 63 years STANDARD_DEVIATION 9 | 62 years STANDARD_DEVIATION 10 |
| Sex: Female, Male Female | 80 Participants | 80 Participants | 76 Participants | 236 Participants |
| Sex: Female, Male Male | 67 Participants | 72 Participants | 62 Participants | 201 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 147 | 0 / 152 | 0 / 138 |
| serious Total, serious adverse events | 0 / 147 | 0 / 152 | 0 / 138 |
Outcome results
Primary
Opioid Consumption
cumulative opioid consumption, where all opioids were converted to IV morphine equivalents
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasound Guidance Alone | Opioid Consumption | 57 mg morphine equivalents |
| Ultrasound Guidance Needle Stimulation | Opioid Consumption | 58 mg morphine equivalents |
| Ultrasound Guidance+Catheter Stimulation | Opioid Consumption | 55 mg morphine equivalents |
Comparison: The primary analysis for opioid was a linear regression model comparing stimulating catheter to stimulating needle on the log of cumulative opioid consumption score for a patient in the first 48 hours.p-value: 0.0495% CI: [-17, 34]t-test, 2 sided
Comparison: 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.p-value: 0.00295% CI: [-25, 21]t-test, 2 sided
Comparison: 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.p-value: 0.0395% CI: [-25, 21]t-test, 2 sided
Comparison: 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.p-value: 0.00595% CI: [-24, 23]t-test, 2 sided
Comparison: 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.p-value: 0.00695% CI: [-22, 25]t-test, 2 sided
Comparison: 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.p-value: 0.0295% CI: [-20, 29]t-test, 2 sided
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.).
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Guidance Alone | Time Weighted Average Verbal Response Scale Pain Score | 3.52 units on a scale | Standard Deviation 1.62 |
| Ultrasound Guidance Needle Stimulation | Time Weighted Average Verbal Response Scale Pain Score | 3.24 units on a scale | Standard Deviation 1.55 |
| Ultrasound Guidance+Catheter Stimulation | Time Weighted Average Verbal Response Scale Pain Score | 3.40 units on a scale | Standard Deviation 1.47 |
Comparison: The primary analysis for pain was a linear regression model comparing stimulating needle to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.p-value: <0.00195% CI: [-0.61, 0.29]t-test, 2 sided
Comparison: The primary analysis for pain was a linear regression model comparing stimulating catheter to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.p-value: 0.0395% CI: [-0.29, 0.61]t-test, 2 sided
Comparison: The primary analysis for pain was a linear regression model comparing stimulating catheter to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.p-value: <0.00195% CI: [-0.57, 0.33]t-test, 2 sided
Comparison: The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating catheter on the mean time-weighted average pain score for a patient in the first 48 hours.p-value: 0.0295% CI: [-0.33, 0.57]t-test, 2 sided
Comparison: The primary analysis for pain was a linear regression model comparing stimulating needle to ultrasound alone on the mean time-weighted average pain score for a patient in the first 48 hours.p-value: <0.00195% CI: [-0.72, 0.16]t-test, 2 sided
Comparison: The primary analysis for pain was a linear regression model comparing ultrasound alone to stimulating needle on the mean time-weighted average pain score for a patient in the first 48 hours.p-value: 0.1195% CI: [-0.16, 0.72]t-test, 2 sided
Secondary
Block Performance Time
Block performance time, defined as the time from block start until catheter placement.
Time frame: time elapsed from beginning the block to catheter placement
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ultrasound Guidance Alone | Block Performance Time | 110 seconds |
| Ultrasound Guidance Needle Stimulation | Block Performance Time | 150 seconds |
| Ultrasound Guidance+Catheter Stimulation | Block Performance Time | 177 seconds |
Comparison: Stimulating needle versus stimulating catheter.p-value: 0.11ANOVA
Comparison: Stimulating needle versus ultrasound guidance alonep-value: 0.0195% CI: [6, 75]ANOVA
Comparison: Stimulating catheter versus ultrasound guidance alonep-value: <0.00195% CI: [31, 102]ANOVA
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.
Time frame: postoperative period when block is used
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound Guidance Alone | Incremental Cost of Femoral Nerve Blocks | 14 dollars | Standard Deviation 0 |
| Ultrasound Guidance Needle Stimulation | Incremental Cost of Femoral Nerve Blocks | 36 dollars | Standard Deviation 0 |
| Ultrasound Guidance+Catheter Stimulation | Incremental Cost of Femoral Nerve Blocks | 50 dollars | Standard Deviation 0 |
Comparison: We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.
Comparison: We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.
Comparison: We calculated incremental cost, defined as the additional cost of one strategy to the next less costly strategy.