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Clinical Comparison of Femoral Nerve Versus Adductor Canal Block Following Anterior Ligament Reconstruction (FNB vs ACB)

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ClinicalTrials.gov Identifier: NCT03704376
Recruitment Status : Active, not recruiting
First Posted : October 12, 2018
Results First Posted : December 11, 2018
Last Update Posted : December 11, 2018
Sponsor:
Collaborator:
Memorial Hermann Hospital
Information provided by (Responsible Party):
Lane Bailey, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Anterior Cruciate Ligament Injury
Interventions Drug: 30 ml of 0.2% ropivacaine
Drug: 15 ml of 0.2% ropivacaine
Drug: 100 mcg clonidine
Device: High-frequency linear ultrasound transducer
Enrollment 125
Recruitment Details  
Pre-assignment Details 125 were enrolled, but 39 were excluded because they ended up receiving a different type of graft.
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 42 44
Completed 38 40
Not Completed 4 4
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 38 40 78
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 40 participants 78 participants
24.4  (8.8) 21.0  (7.3) 22.7  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 40 participants 78 participants
Female
18
  47.4%
17
  42.5%
35
  44.9%
Male
20
  52.6%
23
  57.5%
43
  55.1%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants 40 participants 78 participants
38
 100.0%
40
 100.0%
78
 100.0%
1.Primary Outcome
Title Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)
Hide Description 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.
Time Frame Post-operative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: microvolts (uV)
266.5  (52.4) 212.5  (65.1)
2.Primary Outcome
Title Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Hide Description 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.
Time Frame Post-operative day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: microvolts (uV)
183.2  (41.8) 126.5  (48.9)
3.Primary Outcome
Title Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
Hide Description 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.
Time Frame 4 weeks post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: microvolts (uV)
109.1  (32.2) 94.1  (33.2)
4.Secondary Outcome
Title Straight Leg Raise Test
Hide Description The 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.
Time Frame Post-operative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: number of repetitions
3.2  (6.1) 6.2  (8.0)
5.Secondary Outcome
Title Straight Leg Raise Test
Hide Description The 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.
Time Frame Post-operative day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: number of repetitions
23.3  (10.6) 24.2  (10.9)
6.Secondary Outcome
Title Straight Leg Raise Test
Hide Description The 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.
Time Frame 4 weeks post operative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: number of repetitions
29.7  (1.4) 30  (0.0)
7.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, 0 being the better outcome.
Time Frame 1 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.81  (2.09) 0.8  (2.23)
8.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 2 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.78  (2.61) 2.13  (3.2)
9.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better
Time Frame 3 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.65  (2.8) 3.23  (3.3)
10.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 4 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.83  (2.6) 2.87  (3.08)
11.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 5 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.97  (2.47) 3.06  (2.94)
12.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 6 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.63  (2.51) 3.03  (2.99)
13.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 7 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.83  (2.22) 2.81  (2.63)
14.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 8 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.84  (2.04) 2.57  (2.63)
15.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 9 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.91  (2.07) 2.41  (2.27)
16.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 10 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
2  (1.9) 2.53  (1.89)
17.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 11 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time Frame 12 hr post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
Hide Description The items are scored on a visual analogical scale from 0-10, with 0 being the better
Time Frame Postoperative physicians visit
Outcome Measure Data Not Reported
20.Secondary Outcome
Title Narcotics Use as Assessed by Morphine Equivalents Consumed
Hide Description morphine 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.
Time Frame Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 38 40
Mean (Standard Deviation)
Unit of Measure: milligrams (mg)
14.8  (8.3) 16.0  (7.4)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Femoral Nerve Blockade Adductor Canal Blockade
Hide Arm/Group Description

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

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

All-Cause Mortality
Femoral Nerve Blockade Adductor Canal Blockade
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/40 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Femoral Nerve Blockade Adductor Canal Blockade
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Femoral Nerve Blockade Adductor Canal Blockade
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/38 (42.11%)      11/40 (27.50%)    
Musculoskeletal and connective tissue disorders     
Anterior Knee Pain *  7/38 (18.42%)  7 8/40 (20.00%)  8
Knee Extension Loss *  8/38 (21.05%)  8 2/40 (5.00%)  2
Reinjury *  1/38 (2.63%)  1 0/40 (0.00%)  0
Vascular disorders     
Deep Vein Thrombosis *  0/38 (0.00%)  0 1/40 (2.50%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Lane Bailey, PhD, PT
Organization: The University of Texas Health Science Center at Houston
Phone: 713-704-6794
Responsible Party: Lane Bailey, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03704376     History of Changes
Other Study ID Numbers: HSC-MH-14-0734 (addendum)
First Submitted: September 27, 2018
First Posted: October 12, 2018
Results First Submitted: November 16, 2018
Results First Posted: December 11, 2018
Last Update Posted: December 11, 2018