| Primary | Opioid Utilization in First 24 Hours Post-Surgery | Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent. | | Posted | | Mean | Standard Deviation | morphine milligram equivalents | | Up to Hour 24 Post-Operation | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0006.1± 5.5
- OG00110.7± 7.1
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| Secondary | Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score ranges from 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Hour 24 Post-Operation | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Patient-Reported VAS Scores at 48 Hours Post-Surgery | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Hour 48 Post-Operation | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Patient-Reported VAS Scores at 72 Hours Post-Surgery | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Hour 72 Post-Operation | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Patient-Reported VAS Scores at Day 7 Post-Surgery | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Day 7 Post-Operation | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Length of Stay in Post-Anesthesia Care Unit (PACU) | Measured by the length of stay after surgery (minutes) | | Posted | | Mean | Standard Deviation | Minutes | | Up to Day 1 Post-Operation | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS) | The KOOS-PS is a 7-item measure of physical functional derived from the items of the Function, daily living and Function, sports and recreational activity subscales of the KOOS. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The raw score is calculated by summing the responses and ranges from 0-28. The raw score is converted to a true interval score ranging from 0-100, where higher scores indicate greater physical function. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Month 6 Post-Operation Visit | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Change in Kujala Scale Score | Knee pain will be measured by self reported Kujala scale. The Kujala Scale is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The total score ranges from 0 to 100; higher scores indicate lesser knee pain. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Month 6 Post-Operation Visit | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Change in Tegner Activity Scale (TAS) Score | The TAS asks participants to indicate the highest level of activity they are able to participate in at the time of the survey. The options range from Level 10 (competitive sports on a national elite level) to Level 0 (sick leave or disability pension because of knee problems). The total score corresponds with the selected Level and ranges from 0-10; higher scores indicate higher levels of activity. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline, Month 6 Post-Operation Visit | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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| Secondary | Change of Range of Motion (ROM) Assessment | A Range of Motion (ROM) assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures of knee ROM will be taken at baseline and Month 6 to assess the change in ROM over time. | No participants had data collected/were analyzed for the purposes of this outcome measure. | Posted | | | | | | Baseline, Month 6 Post-Operation Visit | | | | ID | Title | Description |
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| OG000 | Participants Receiving IPACK Block | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. IPACK block: IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | | OG001 | Standard of Care Group | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
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