An interventional study of High Pressure Injection and Low Pressure Injection in Orthopedic Disorders and Injury of Anterior Cruciate Ligament, sponsored by University of Miami. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by University of Miami · Not applicable, Interventional, and Prevention
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.
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.
657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.
This study's enrollment of 26 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.
Browse Musculoskeletal Diseases studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
High pressure injection of Ropivacaine local anesthetic at greater than 20 psi
Procedure: High Pressure Injection
Low pressure injection of Ropivacaine local anesthetic at less than 15 psi
Procedure: Low Pressure Injection
Adductor canal block performed at greater than 20 psi injection pressure
Adductor canal block performed at less than 15 psi injection pressure
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
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
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
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
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
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
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
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
Opioid Administration
Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).
Time frame: day 1
| Milestone | High Pressure | Low Pressure |
|---|---|---|
| Started | 12 | 14 |
| Completed | 12 | 14 |
| Not completed | 0 | 0 |
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.
| cm | High Pressure | Low Pressure |
|---|---|---|
| Spread of Injectate | 18.5 (8.5 to 29) | 10 (2 to 16.5) |
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.
| Events | High Pressure | Low Pressure |
|---|---|---|
| Number of Events of Femoral Nerve Block 30 Minutes After Block Placement | 0 | 0 |
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.
| Events | High Pressure | Low Pressure |
|---|---|---|
| Number of Events of Sciatic Nerve Block 30 Minutes After Block Placement | 0 | 0 |
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.
| score on a scale | High Pressure | Low Pressure |
|---|---|---|
| Postoperative Pain Scores (Numeric Rating Scale, 0-10) | 3 (2 to 3) | 4 (3.25 to 5.75) |
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).
| score on a scale | High Pressure | Low Pressure |
|---|---|---|
| Postoperative Physical Therapy Milestone Achievement | 47 (18 to 68) | 30 (8 to 55) |
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).
| score on a scale | High Pressure | Low Pressure |
|---|---|---|
| Postoperative Physical Therapy Milestone Achievement | 53 (32 to 75) | 50 (22 to 58) |
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).
| score on a scale | High Pressure | Low Pressure |
|---|---|---|
| Postoperative Physical Therapy Milestone Achievement | 60 (30 to 72) | 51 (40 to 70) |
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).
| score on a scale | High Pressure | Low Pressure |
|---|---|---|
| Postoperative Physical Therapy Milestone Achievement | 70 (59 to 78) | 65 (20 to 69) |
Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams).
| milligrams | High Pressure | Low Pressure |
|---|---|---|
| Opioid Administration | 20.909 ± 2.827 | 16.033 ± 2.438 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Pressure | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Low Pressure | 0/14 (0%) | 0/14 (0%) | 0/14 (0%) |
| Age, Categorical(Participants) | High Pressure | Low Pressure | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 12 | 14 | 26 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | High Pressure | Low Pressure | Total |
|---|---|---|---|
| Female | 7 | 4 | 11 |
| Male | 5 | 10 | 15 |
| Race and Ethnicity Not Collected(Participants) | High Pressure | Low Pressure | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Miami