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Unable to recruit additional patients due to transfer of surgical service (ortho sports medicine) and recruitable cases to another institution.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Pressure | Experimental | High pressure injection of Ropivacaine local anesthetic at greater than 20 psi |
|
| Low Pressure | Active Comparator | Low pressure injection of Ropivacaine local anesthetic at less than 15 psi |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Pressure Injection | Procedure | Adductor canal block performed at greater than 20 psi injection pressure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate post-procedure on day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andres Missair, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Hospital | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Full Range | cm | Immediate post-procedure on day 1 |
|
1 day
Adverse events collected as related to intervention only, as assessed by treating physician.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Trial was terminated early due to inability to recruit additional subjects after the participating surgeons were staffed at a different hospital and no replacement surgical service was established.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andres Missair | University of Miami | 3055857037 | amissair@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 10, 2015 | Dec 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| Low Pressure Injection | Procedure | Adductor canal block performed at less than 15 psi injection pressure |
|
| 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. | 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. | 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). | 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). | 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). | 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). | postoperative week 4 |
| Opioid Administration | Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams). | day 1 |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
|
|
| 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. | Posted | Number | Events | post-procedure and postoperative on day 1 |
|
|
|
| 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. | Posted | Number | Events | post-procedure and postoperative on day 1 |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | score on a scale | postoperative on day 1 |
|
|
|
| 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). | Posted | Mean | Full Range | score on a scale | postoperative week 1 |
|
|
|
| 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). | Posted | Mean | Full Range | score on a scale | postoperative week 2 |
|
|
|
| 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). | Posted | Mean | Full Range | score on a scale | postoperative week 3 |
|
|
|
| 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). | Posted | Mean | Full Range | score on a scale | postoperative week 4 |
|
|
|
| Secondary | Opioid Administration | Intraoperative and immediate postoperative opioid administration. Calculated as morphine milliequivalent (in milligrams). | Posted | Mean | Standard Error | milligrams | day 1 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 | 0 | 14 | 0 | 14 | 0 | 14 |
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