Injury of Anterior Cruciate Ligament, Orthopedic Disorders
Conditions
Brief summary
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block.
Detailed description
This is a prospective, randomized, single-blinded human clinical trial that will examine how injection pressure influences the spread of a given volume of injectate in the adductor canal, during adductor canal nerve block. The study population will be patients undergoing elective anterior cruciate ligament repair in the distal lower extremity and receiving preoperative adductor canal nerve blocks for postoperative analgesia. They will be randomized into two groups of 25 patients each. The investigators speculate that high injection pressures (\>20 psi) will lead to greater spread of local anesthetic than low injection pressures (\<15 psi) during mid-thigh adductor canal nerve blocks. The primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound. The secondary endpoints are the incidence of femoral and sciatic nerve blocks 30 minutes after block placement, amount of IV opioid administered intraoperatively and postoperatively, preoperative and postoperative pain (Numeric Rating Scale, 0-10), and postoperative physical therapy milestone achievement.
Interventions
PROCEDURELow Pressure Injection
Adductor canal block performed at less than 15 psi injection pressure
PROCEDUREHigh Pressure Injection
Adductor canal block performed at greater than 20 psi injection pressure
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Planned general anesthetic. 2. American Society of Anesthesia classes I, II, or III. 3. Patients aged 18-65. 4. English-speaking patients.
Exclusion criteria
1. ASA classes IV and V. 2. Patients younger than 18 or older than 65. 3. Contraindication to regional anesthesia (coagulopathy, patient refusal). 4. Allergy to local anesthetic or other study medications. 5. BMI \> 35 kg/m2. 6. Chronic opioid use (daily or almost daily use for \> 3 months). 7. Active illicit drug use. 8. Additional surgical site other than the limb for adductor canal block. 9. Pregnancy. 10. Preexisting neuropathy in the operative limb. 11. Inability to communicate to investigators or hospital staff. 12. Inability to speak or understand English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spread of Injectate | Immediate post-procedure on day 1 | Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Events of Femoral Nerve Block 30 Minutes After Block Placement | post-procedure and postoperative on day 1 | Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the femoral nerve distribution, then an outcome of a femoral nerve block will be recorded. |
| Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement | post-procedure and postoperative on day 1 | Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the sciatic nerve distribution, then an outcome of a sciatic nerve block will be recorded. |
| Postoperative Pain Scores (Numeric Rating Scale, 0-10) | postoperative on day 1 | Patients will rate their pain after surgery on a scale from 0-10, with 0 being no pain, and 10 being the worst pain of their life. |
| Postoperative Physical Therapy Milestone Achievement | postoperative week 1 | The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional). |
| Opioid Administration | day 1 | Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Pressure High pressure injection of Ropivacaine local anesthetic at greater than 20 psi
High Pressure Injection: Adductor canal block performed at greater than 20 psi injection pressure
High Pressure Injection: Ropivacaine 0.2% injection at greater than 20 psi injection pressure | 12 |
| Low Pressure Low pressure injection of Ropivacaine local anesthetic at less than 15 psi
Low Pressure Injection: Adductor canal block performed at less than 15 psi injection pressure
Low Pressure Injection: Ropivacaine 0.2% injection at less than 15 psi injection pressure | 14 |
| Total | 26 |
Baseline characteristics
| Characteristic | High Pressure | Low Pressure | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 14 Participants | 26 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 5 Participants | 10 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 0 / 12 | 0 / 14 |
| serious Total, serious adverse events | 0 / 12 | 0 / 14 |
Outcome results
Primary
Spread of Injectate
Our primary endpoint is the spread of injectate, defined as the distance between the uppermost and lowermost limits of spread of local anesthetic as assessed by ultrasound.
Time frame: Immediate post-procedure on day 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Pressure | Spread of Injectate | 18.5 cm |
| Low Pressure | Spread of Injectate | 10 cm |
Secondary
Number of Events of Femoral Nerve Block 30 Minutes After Block Placement
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the femoral nerve distribution, then an outcome of a femoral nerve block will be recorded.
Time frame: post-procedure and postoperative on day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Pressure | Number of Events of Femoral Nerve Block 30 Minutes After Block Placement | 0 Events |
| Low Pressure | Number of Events of Femoral Nerve Block 30 Minutes After Block Placement | 0 Events |
Secondary
Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement
Sensory testing will use a pinprick method in the femoral (anterior thigh), saphenous (medial calf proximal to the medial malleolus, top of the patella) and sciatic (posterolateral calf, plantar surface of the foot) nerve distributions; if patients are unable to feel the stimulus in the sciatic nerve distribution, then an outcome of a sciatic nerve block will be recorded.
Time frame: post-procedure and postoperative on day 1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Pressure | Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement | 0 Events |
| Low Pressure | Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement | 0 Events |
Secondary
Opioid Administration
Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).
Time frame: day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Pressure | Opioid Administration | 20.909 milligrams | Standard Error 2.827 |
| Low Pressure | Opioid Administration | 16.033 milligrams | Standard Error 2.438 |
Secondary
Postoperative Pain Scores (Numeric Rating Scale, 0-10)
Patients will rate their pain after surgery on a scale from 0-10, with 0 being no pain, and 10 being the worst pain of their life.
Time frame: postoperative on day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Pressure | Postoperative Pain Scores (Numeric Rating Scale, 0-10) | 3 score on a scale |
| Low Pressure | Postoperative Pain Scores (Numeric Rating Scale, 0-10) | 4 score on a scale |
Secondary
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time frame: postoperative week 1
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Pressure | Postoperative Physical Therapy Milestone Achievement | 47 score on a scale |
| Low Pressure | Postoperative Physical Therapy Milestone Achievement | 30 score on a scale |
Secondary
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time frame: postoperative week 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Pressure | Postoperative Physical Therapy Milestone Achievement | 53 score on a scale |
| Low Pressure | Postoperative Physical Therapy Milestone Achievement | 50 score on a scale |
Secondary
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time frame: postoperative week 3
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Pressure | Postoperative Physical Therapy Milestone Achievement | 60 score on a scale |
| Low Pressure | Postoperative Physical Therapy Milestone Achievement | 51 score on a scale |
Secondary
Postoperative Physical Therapy Milestone Achievement
The patient will be evaluated by physical therapy postoperatively using the Lower Extremity Function Scale (LEFS). The LEFS is a self-reporting measure (0-80 score range, where 0 is complete disability and 80 is fully functional).
Time frame: postoperative week 4
| Arm | Measure | Value (MEAN) |
|---|---|---|
| High Pressure | Postoperative Physical Therapy Milestone Achievement | 70 score on a scale |
| Low Pressure | Postoperative Physical Therapy Milestone Achievement | 65 score on a scale |