Trial Outcomes & Findings for Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction (NCT NCT03704376)
NCT ID: NCT03704376
Last Updated: 2021-10-21
Results Overview
Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
COMPLETED
PHASE4
125 participants
Post-operative day 1
2021-10-21
Participant Flow
125 were enrolled, but 39 were excluded because they ended up receiving a different type of graft.
Participant milestones
| Measure |
Femoral Nerve Blockade
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
44
|
|
Overall Study
COMPLETED
|
38
|
40
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
24.4 years
STANDARD_DEVIATION 8.8 • n=38 Participants
|
21.0 years
STANDARD_DEVIATION 7.3 • n=40 Participants
|
22.7 years
STANDARD_DEVIATION 8.1 • n=78 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=38 Participants
|
17 Participants
n=40 Participants
|
35 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=38 Participants
|
23 Participants
n=40 Participants
|
43 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
38 Participants
n=38 Participants
|
40 Participants
n=40 Participants
|
78 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: Post-operative day 1Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)
|
266.5 microvolts (uV)
Standard Deviation 52.4
|
212.5 microvolts (uV)
Standard Deviation 65.1
|
PRIMARY outcome
Timeframe: Post-operative day 14Quadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
|
183.2 microvolts (uV)
Standard Deviation 41.8
|
126.5 microvolts (uV)
Standard Deviation 48.9
|
PRIMARY outcome
Timeframe: 4 weeks post operativeQuadriceps muscle activation was examined using surface electromyography (sEMG) of the vastus medialis oblique muscle. Peak sEMG activity was recorded in microvolts (uV) on the surgical and contralateral limbs while performing five maximal effort isometric contractions in full knee extension--the reported values are equal to the quadriceps sEMG in uV of the contralateral limb minus the quadriceps sEMG in uV of the surgical limb.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
|
109.1 microvolts (uV)
Standard Deviation 32.2
|
94.1 microvolts (uV)
Standard Deviation 33.2
|
SECONDARY outcome
Timeframe: Post-operative day 1The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Number of Successful Repetitions With Straight Leg Raise Test
|
3.2 number of repetitions
Standard Deviation 6.1
|
6.2 number of repetitions
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Post-operative day 14The straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Number of Successful Repetitions With Straight Leg Raise Test
|
23.3 number of repetitions
Standard Deviation 10.6
|
24.2 number of repetitions
Standard Deviation 10.9
|
SECONDARY outcome
Timeframe: 4 weeks post operativeThe straight leg raise assessment was performed in a standardized long-sitting position with well-knee flexed to 90 degrees. Patients were asked to complete 30 repetitions of straight leg raises with a small bolster supporting the heel using the following criteria; (1) perform with no visible quad lag (2) reach the height of the opposite tibial tubercle and (3) maintain a controlled rate of 30 hertz for the ascending and descending phases. The examination was only performed on the surgical limb and the absolute number of successful repetitions is reported.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Number of Successful Repetitions With Straight Leg Raise Test
|
29.7 number of repetitions
Standard Deviation 1.4
|
30 number of repetitions
Standard Deviation 0.0
|
SECONDARY outcome
Timeframe: 1 hr post surgeryThe items are scored on a visual analogical scale from 0-10, 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
0.81 units on a scale
Standard Deviation 2.09
|
0.8 units on a scale
Standard Deviation 2.23
|
SECONDARY outcome
Timeframe: 2 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
1.78 units on a scale
Standard Deviation 2.61
|
2.13 units on a scale
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: 3 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2.65 units on a scale
Standard Deviation 2.8
|
3.23 units on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 4 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2.83 units on a scale
Standard Deviation 2.6
|
2.87 units on a scale
Standard Deviation 3.08
|
SECONDARY outcome
Timeframe: 5 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2.97 units on a scale
Standard Deviation 2.47
|
3.06 units on a scale
Standard Deviation 2.94
|
SECONDARY outcome
Timeframe: 6 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2.63 units on a scale
Standard Deviation 2.51
|
3.03 units on a scale
Standard Deviation 2.99
|
SECONDARY outcome
Timeframe: 7 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2.83 units on a scale
Standard Deviation 2.22
|
2.81 units on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: 8 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2.84 units on a scale
Standard Deviation 2.04
|
2.57 units on a scale
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: 9 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2.91 units on a scale
Standard Deviation 2.07
|
2.41 units on a scale
Standard Deviation 2.27
|
SECONDARY outcome
Timeframe: 10 hr post surgeryThe items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
|
2 units on a scale
Standard Deviation 1.9
|
2.53 units on a scale
Standard Deviation 1.89
|
SECONDARY outcome
Timeframe: 11 hr post surgeryPopulation: No participants were analyzed for this time point because participants were discharged from hospital at around 10 hours, before this time point would have occurred.
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 hr post surgeryPopulation: No participants were analyzed for this time point because participants were discharged from hospital at around 10 hours, before this time point would have occurred.
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Postoperative physicians visitPopulation: Patients were not analyzed at postoperative physicians visit.
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgerymorphine equivalents consumed during the entire post-anesthesia care unit (PACU) visit post surgery will be obtained from the All-scripts electronic medical record (EMR) system.
Outcome measures
| Measure |
Femoral Nerve Blockade
n=38 Participants
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 Participants
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Narcotics Use as Assessed by Morphine Equivalents Consumed
|
14.8 milligrams (mg)
Standard Deviation 8.3
|
16.0 milligrams (mg)
Standard Deviation 7.4
|
Adverse Events
Femoral Nerve Blockade
Adductor Canal Blockade
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Femoral Nerve Blockade
n=38 participants at risk
Ultrasound guided FNB (30 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) below the inguinal ligament using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ) with stimulator confirmation.
30 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
Adductor Canal Blockade
n=40 participants at risk
Ultrasound guided ACB (15 ml of 0.2% ropivacaine with 100 mcg clonidine using a 22-gauge 40 mm ProBloc II insulated needle; Kimberly-Clark, Roswell, Georgia) at the mid-thigh using a high-frequency linear ultrasound transducer (4-12 Hz; Mindray M7; Mindray North America, Mahwah, NJ).
15 ml of 0.2% ropivacaine
100 mcg clonidine
High-frequency linear ultrasound transducer
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Anterior Knee Pain
|
18.4%
7/38 • Number of events 7 • 6 months
|
20.0%
8/40 • Number of events 8 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Knee Extension Loss
|
21.1%
8/38 • Number of events 8 • 6 months
|
5.0%
2/40 • Number of events 2 • 6 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/38 • 6 months
|
2.5%
1/40 • Number of events 1 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Reinjury
|
2.6%
1/38 • Number of events 1 • 6 months
|
0.00%
0/40 • 6 months
|
Additional Information
Lane Bailey, PhD, PT
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place