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This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACB + iPACK | Experimental | Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). |
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| ACB w/o iPACK | No Intervention | Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK) | Drug | nerve block for posterior knee pain after a TKA. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery | Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator | Six hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score Measurement Reported by Patients | Average of pain scores over the first 24 hours following the regional anesthetic based on Numeric Rating Scale ( NRS). The scale is from 0 - 10, where 0 is no pain and 10 is the worst pain possible. | 24 hours after surgery |
| Quality of Recovery (QoR) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taras Grosh, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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120 patients enrolled, 119 patients completed all necessary follow-up for inclusion in the study: 60 patients in the IPACK group and 59 patients in the sham group. There were no block failures. These 119 patients were randomized to receive either an IPACK or a sham block in addition to multimodal analgesia and an ACB. We were set to assess pain in the back of the knee 6 hours after surgery, quality of recovery after surgery, pain scores, opioid requirements, and functional measures
Four hundred and sixty-four patients were screened for eligibility, with 120 patients ultimately enrolling in the study. Of the 120 patients enrolled, 119 patients completed all necessary follow-up for inclusion into the study
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| ID | Title | Description |
|---|---|---|
| FG000 | ACB + iPACK | Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA. |
| FG001 | ACB w/o iPACK | Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ACB + iPACK | Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery | Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator | Posted | Number | percentage of patients reporting pain | Six hours after surgery |
|
48 hours
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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 | ACB + iPACK | Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK): nerve block for posterior knee pain after a TKA. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nabil Elkassbany, MD | University of Pennsylvania | 2158236700 | nabil.elkassabany@uphs.upenn.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 | Oct 15, 2018 | Aug 2, 2023 | Prot_SAP_000.pdf |
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This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
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Score of QoR-15 survey to determine recovery status. The questionnaire is a 15 item questionnaire and each question has a score possible from 0-10. It has two parts. Part 1 includes questions from 1-10. the scale on this question ranges from 0=none of the time ( poor) to 10=all the time ( excellent). The 2nd part include questions from 11-15 where the scale goes from 10 to 0, where 10=none of the time ( excellent) and 0=all the time (poor). The total score is obtained by adding the scores of all the 15 questions. The total score is 0 (poor_ to 150 (excellent). |
| one week, measurements are obtained at 24 hours, 48 hours, and one week |
| BG001 | ACB w/o iPACK | Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. |
| BG002 | Total | Total of all reporting groups |
| Age (years) |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| OG001 | ACB w/o iPACK | Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. |
|
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| Secondary | Pain Score Measurement Reported by Patients | Average of pain scores over the first 24 hours following the regional anesthetic based on Numeric Rating Scale ( NRS). The scale is from 0 - 10, where 0 is no pain and 10 is the worst pain possible. | Posted | Mean | Standard Deviation | pain scores | 24 hours after surgery |
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|
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| Secondary | Quality of Recovery (QoR) Score | Score of QoR-15 survey to determine recovery status. The questionnaire is a 15 item questionnaire and each question has a score possible from 0-10. It has two parts. Part 1 includes questions from 1-10. the scale on this question ranges from 0=none of the time ( poor) to 10=all the time ( excellent). The 2nd part include questions from 11-15 where the scale goes from 10 to 0, where 10=none of the time ( excellent) and 0=all the time (poor). The total score is obtained by adding the scores of all the 15 questions. The total score is 0 (poor_ to 150 (excellent). | Posted | Median | Standard Deviation | score on a scale | one week, measurements are obtained at 24 hours, 48 hours, and one week |
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| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | ACB w/o iPACK | Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. | 0 | 59 | 0 | 59 | 0 | 59 |
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| Postoperative Day 7 |
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