Anterior Cruciate Ligament Injury
Conditions
Keywords
Femoral Nerve Block, Adductor Canal Block
Brief summary
This study will examine the potential differences between femoral nerve blockade (FNB) and adductor canal blockade (ACB) for pain control and quadriceps muscle activation for patients following anterior cruciate ligament (ACL) reconstruction.
Detailed description
Adequate pain control following anterior cruciate ligament reconstruction (ACL) often requires a regional nerve block. The femoral nerve block (FNB) has been traditionally employed. More recently, ultrasound application to regional nerve blocks allows for the use of alternatives such as the adductor canal block following ACL reconstruction. In 2009, Manickam et al. were the first to describe the ultrasound guided adductor canal technique for the purposes of knee joint analgesia. Unlike other traditional techniques that seek to cause a sensory as well as a motor blockade, the adductor canal block attempts to spare the motor block of the neighboring distributions in an attempt to offer selective analgesia and strength preservation. Chisholm et al demonstrated the adductor canal block provides similar and adequate postoperative analgesia when compared to the FNB, following arthroscopic ACL reconstruction with patellar tendon autograft. Their study focused on analgesia and did not evaluate quadriceps function or impact on rehabilitation. Sharma et al drew the first association between femoral nerve blocks and increased fall risk due to muscle weakness in total knee arthroplasty population. A randomized, blinded study to compare quadriceps strength following adductor canal versus FNB was performed by Kwofie et al. They showed that compared with FNB, adductor canal block results in significant quadriceps motor sparing and significantly preserved balance. These studies focused on acute muscle weakness after regional anesthesia and its relation to safety. Quadriceps function is very important in rehabilitation of ACL reconstruction. Luo et al demonstrated long term deficits related to FNB. They demonstrated that patients treated with FNB after ACL reconstruction had significant isokinetic deficits in knee extension and flexion strength at 6 months when compared with patients who did not receive a nerve block. Patients without a block were 4 times more likely to meet criteria for clearance to return to sports at 6 months. In addition, Krych et al found significantly inferior quadriceps strength and function at 6 months in FNB group. Based on the available literature, we aim to compare femoral nerve versus adductor canal block in regards to pain control and muscle strength in ACL reconstruction patients until return to sport.
Interventions
DRUG30 ml of 0.2% ropivacaine
DRUG15 ml of 0.2% ropivacaine
DRUG100 mcg clonidine
DEVICEHigh-frequency linear ultrasound transducer
Sponsors
Memorial Hermann Hospital
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
* Males & Females ages 16-30 yrs * Undergoing ACL reconstruction by Co-Investigator (Walter Lowe) * Receiving peri-operative FNB or ACB
Exclusion criteria
* Not enrolled within the COFAKS study * Receiving intrathecal nerve blockade or no blockade
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG) | Post-operative day 1 | 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. |
| Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG) | Post-operative day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Successful Repetitions With Straight Leg Raise Test | Post-operative day 1 | 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. |
| Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 1 hr post surgery | The items are scored on a visual analogical scale from 0-10, 0 being the better outcome. |
| Narcotics Use as Assessed by Morphine Equivalents Consumed | Entire post-anesthesia care unit (PACU) visit post surgery, PACU range 1 hr to 12 hrs post surgery | 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. |
Countries
United States
Participant flow
Pre-assignment details
125 were enrolled, but 39 were excluded because they ended up receiving a different type of graft.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 38 |
| 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 | 40 |
| Total | 78 |
Baseline characteristics
| Characteristic | Adductor Canal Blockade | Total | Femoral Nerve Blockade |
|---|---|---|---|
| Age, Continuous | 21.0 years STANDARD_DEVIATION 7.3 | 22.7 years STANDARD_DEVIATION 8.1 | 24.4 years STANDARD_DEVIATION 8.8 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 40 Participants | 78 Participants | 38 Participants |
| Sex: Female, Male Female | 17 Participants | 35 Participants | 18 Participants |
| Sex: Female, Male Male | 23 Participants | 43 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 40 |
| other Total, other adverse events | 16 / 38 | 11 / 40 |
| serious Total, serious adverse events | 0 / 38 | 0 / 40 |
Outcome results
Primary
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG) | 183.2 microvolts (uV) | Standard Deviation 41.8 |
| Adductor Canal Blockade | Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG) | 126.5 microvolts (uV) | Standard Deviation 48.9 |
Primary
Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG) | 109.1 microvolts (uV) | Standard Deviation 32.2 |
| Adductor Canal Blockade | Quadriceps Muscle Activation as Assessed by Surface Electromyography (EMG) | 94.1 microvolts (uV) | Standard Deviation 33.2 |
Primary
Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG) | 266.5 microvolts (uV) | Standard Deviation 52.4 |
| Adductor Canal Blockade | Quadriceps Muscle Activation as Assessed by Surface Electromyography (sEMG) | 212.5 microvolts (uV) | Standard Deviation 65.1 |
Secondary
Narcotics Use as Assessed by Morphine Equivalents Consumed
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Narcotics Use as Assessed by Morphine Equivalents Consumed | 14.8 milligrams (mg) | Standard Deviation 8.3 |
| Adductor Canal Blockade | Narcotics Use as Assessed by Morphine Equivalents Consumed | 16.0 milligrams (mg) | Standard Deviation 7.4 |
Secondary
Number of Successful Repetitions With Straight Leg Raise Test
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Number of Successful Repetitions With Straight Leg Raise Test | 23.3 number of repetitions | Standard Deviation 10.6 |
| Adductor Canal Blockade | Number of Successful Repetitions With Straight Leg Raise Test | 24.2 number of repetitions | Standard Deviation 10.9 |
Secondary
Number of Successful Repetitions With Straight Leg Raise Test
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Number of Successful Repetitions With Straight Leg Raise Test | 29.7 number of repetitions | Standard Deviation 1.4 |
| Adductor Canal Blockade | Number of Successful Repetitions With Straight Leg Raise Test | 30 number of repetitions | Standard Deviation 0 |
Secondary
Number of Successful Repetitions With Straight Leg Raise Test
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Number of Successful Repetitions With Straight Leg Raise Test | 3.2 number of repetitions | Standard Deviation 6.1 |
| Adductor Canal Blockade | Number of Successful Repetitions With Straight Leg Raise Test | 6.2 number of repetitions | Standard Deviation 8 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 2 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 1.78 units on a scale | Standard Deviation 2.61 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.13 units on a scale | Standard Deviation 3.2 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Time frame: 3 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.65 units on a scale | Standard Deviation 2.8 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 3.23 units on a scale | Standard Deviation 3.3 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 4 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.83 units on a scale | Standard Deviation 2.6 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.87 units on a scale | Standard Deviation 3.08 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 5 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.97 units on a scale | Standard Deviation 2.47 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 3.06 units on a scale | Standard Deviation 2.94 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 6 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.63 units on a scale | Standard Deviation 2.51 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 3.03 units on a scale | Standard Deviation 2.99 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 7 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.83 units on a scale | Standard Deviation 2.22 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.81 units on a scale | Standard Deviation 2.63 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 8 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.84 units on a scale | Standard Deviation 2.04 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.57 units on a scale | Standard Deviation 2.63 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 9 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.91 units on a scale | Standard Deviation 2.07 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.41 units on a scale | Standard Deviation 2.27 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 10 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2 units on a scale | Standard Deviation 1.9 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 2.53 units on a scale | Standard Deviation 1.89 |
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 11 hr post surgery
Population: 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.
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better outcome.
Time frame: 12 hr post surgery
Population: 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.
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, with 0 being the better
Time frame: Postoperative physicians visit
Population: Patients were not analyzed at postoperative physicians visit.
Secondary
Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale
The items are scored on a visual analogical scale from 0-10, 0 being the better outcome.
Time frame: 1 hr post surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Femoral Nerve Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 0.81 units on a scale | Standard Deviation 2.09 |
| Adductor Canal Blockade | Postoperative Pain Control as Assessed by a Numeric Pain Rating Scale | 0.8 units on a scale | Standard Deviation 2.23 |