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| ID | Type | Description | Link |
|---|---|---|---|
| IRB 17-01981 | Other Identifier | PPHS, ISMMS |
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Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.
There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipack group | Experimental | 20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well. |
|
| Pai (peri articular) group | Active Comparator | Patients will receive adductor canal catheter and peri articular infiltration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipack | Device | IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Narcotic Consumption | Narcotic consumption in the first 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Score (VAS) for Pain | Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain. | at 6, 12, 18, and 24 hours post procedure |
| Time to First Dose of Narcotic Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yan H Lai, MD,MPH | Ichan School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29721648 | Background | Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2. | |
| 35944566 |
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Participants enrolled from March 2018, and study conducted from June 2018 to August 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Ipack Group | 20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well. Ipack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. |
| FG001 | Pai (Peri Articular) Group | Patients received adductor canal catheter and peri articular infiltration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pai (Peri Articular) Group | Patients received adductor canal catheter and peri articular infiltration. |
| BG001 | Ipack Group | 20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well. Ipack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Narcotic Consumption | Narcotic consumption in the first 24 hours | Posted | Mean | Standard Deviation | morphine equivalents, mg | 24 hours |
|
2 days
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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 | Ipack Group | 20 cc of bupivacaine(o.25%) injected with the help of ultrasound guidance. Patients received adductor canal catheter and peri articular infiltration as well. Ipack: IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Poonam Pai B. H | Icahn School of Medicine at Mount Sinai | 347-569-4816 | poonam.paibantwalhebbalasankatte@mountsinai.org |
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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 22, 2017 | Aug 13, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine | Drug | 20 cc of bupivacaine(o.25%) injection |
|
| Peri Articular Infiltration | Procedure | Adductor Canal Catheter and Peri Articular Infiltration |
|
|
| up to 24 hours |
| PACU Length of Stay | Post-Anesthesia Care Unit (PACU) length of stay (LOS) | average 24 hours |
| Number of Participants With Pain by Location | Location of knee pain as anterior/posterior, medial/lateral | 24 hours |
| Ambulation Distance | Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT | Post-op Day 1 |
| Bartels Index | Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence. | Post-op Day 1 |
| Derived |
| Bh PP, Jinadu S, Okunlola O, Darkzali H, Lin HM, Lai YH. Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. J Knee Surg. 2023 Oct;36(12):1289-1296. doi: 10.1055/s-0042-1755355. Epub 2022 Aug 9. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Side of surgery | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Alcohol Use | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Number of Employed Participants | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Visual Analogue Score (VAS) for Pain | Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain. | Posted | Mean | Standard Deviation | score on a scale | at 6, 12, 18, and 24 hours post procedure |
|
|
|
| Secondary | Time to First Dose of Narcotic Administration | Posted | Median | Inter-Quartile Range | hours | up to 24 hours |
|
|
|
| Secondary | PACU Length of Stay | Post-Anesthesia Care Unit (PACU) length of stay (LOS) | Posted | Median | Inter-Quartile Range | hours | average 24 hours |
|
|
|
| Secondary | Number of Participants With Pain by Location | Location of knee pain as anterior/posterior, medial/lateral | Posted | Count of Participants | Participants | 24 hours |
|
|
|
| Secondary | Ambulation Distance | Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT | Posted | Median | Inter-Quartile Range | meters | Post-op Day 1 |
|
|
|
| Secondary | Bartels Index | Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence. | Posted | Median | Inter-Quartile Range | score on a scale | Post-op Day 1 |
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Pai (Peri Articular) Group | Patients received adductor canal catheter and peri articular infiltration. | 0 | 46 | 0 | 46 | 0 | 46 |
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| D000588 |
| Amines |
| 18 hours |
|
| 24 hours |
|
| Lateral |
|
| Medial |
|
| Posterior |
|
| No Pain |
|