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A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adductor Canal Block (ACB) + IPACK Block | Experimental | Participants receive ACB with IPACK block. |
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| Isolated Adductor Canal Block | Active Comparator | Participants receive ACB only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACB | Drug | 15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal. |
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| Measure | Description | Time Frame |
|---|---|---|
| Opioid Utilization for First 24 Hours Post-Surgery | Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oral morphine equivalent. | Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1]) |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay in PACU | Length of time the patient is in the PACU prior to discharge. | Post-Operation (POD 0 - typically up to 3 hours) |
| Patient-Reported Visual Analogue Scale (VAS) Score - Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laith Jazrawi, MD | Contact | 646-501-7223 | Laith.jazrawi@nyulangone.org |
| Name | Affiliation | Role |
|---|---|---|
| Laith Jazrawi, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
The Investigators will not be sharing this information with other researchers beyond publishing our findings in a scientific journal.
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| IPACK block | Drug | IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee |
|
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
| Baseline |
| Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU) | Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response. | Post-Operation (POD 0 - typically up to 3 hours) |
| Patient-Reported VAS Score - Post-Operative Day 1 (POD 1) | Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response. | POD 1 |
| Patient-Reported VAS Score - Post-Operative Day 2 (POD 2) | Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response. | POD 2 |
| Patient-Reported VAS Score - Post-Operative Day 3 (POD 3) | Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response. | POD 3 |
| Patient-Reported VAS Score - Post-Operative Day 7 (POD 7) | Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response. | POD 7 |
| Patient-Reported VAS Score - Month 6 Follow-Up | Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response. | Month 6 Post-Operation |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline | 7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function. | Baseline |
| KOOS-PS Score - Month 6 Follow-Up | 7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function. | Month 6 Post-Operation |
| Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline | 13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability. | Baseline |
| Kujala Score / AKPS - Month 6 Follow-Up | 13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability. | Month 6 Post-Operation |
| Tegner Activity Scale (TAS) Score - Baseline | The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response. | Baseline |
| Tegner Activity Scale (TAS) Score - Month 6 Follow-Up | The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response. | Month 6 Post-Operation |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |