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The purpose of the study is to compare two types of perioperative analgesic modalities, adductor canal block plus interspace between popliteal artery and capsule of the knee (IPACK) block and periarticular injection versus periarticular injection alone, to determine their relative efficacies with regard to pain relief and functional outcomes in the early postoperative period following primary total knee arthroplasty.
The widespread adoption of multimodal analgesia in contemporary total knee arthroplasty (TKA) has led to improvements in perioperative pain control, expedited recovery times, and shorter hospital stays1-3. Periarticular injections (PAIs), adductor canal blocks (ACBs), and interspace between popliteal artery and capsule of the knee (IPACK) blocks are commonly utilized as part of contemporary multimodal analgesia protocols, but their relative efficacies in improving early recovery after TKA has yet to be definitively elucidated4. There are a few known potential drawbacks of ACBs and IPACKs including surgical delay due to administration timing, increased costs, and small risks associated with a regional block. Both regional anesthesia and PAI have been found to be effective alone in improving pain and opioid consumption, but there is limited data on whether there is an additive benefit of providing both treatments for patients undergoing primary TKA. Therefore, the purpose of our study is to compare the efficacy of regional anesthesia and PAI vs. PAI alone for pain management and functional recovery in the early postoperative period following TKA.
Design Prospective randomized trial
Treatment Groups All ACBs will be administered as a single shot preoperatively in the holding area on the day of surgery by the regional anesthesia team and PAIs will be administered intraoperatively by the treating orthopaedic surgeon.
Group 1: regional anesthesia (ACB + IPACK) and PAI Group 2: PAI alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Block and Periarticular injection | Active Comparator | regional anesthesia (Adductor canal block +IPACK) and Periarticular injection |
|
| Periarticular injectin alone | Active Comparator | Periarticular injection alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| regional anesthesia and PAI | Drug | this is the block portion of the study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively | pain score 0-10 10 being more pain | at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use | opioid medications survey Opioids calculated MMEs (morphine milligram equivalents) milligrams of opioids correlates with the morphine equivalents. Morphine equivalents are standard units used to compare the analgesic potency of different opioids to a reference dose of oral morphine. They calculate total daily, safe, and effective doses | postop day 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Schneider, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | Creve Coeur | Missouri | 63110 | United States |
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patients are randomized once consented. patients have been withdrawn and not all patients are analyzed due to incomplete data . these patients are not patients that are just prescreened. they actually are enrolled and randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Block and Periarticular Injection | regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study |
| FG001 | Periarticular Injectin Alone | Periarticular injection alone PAI: this is the no block portion of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Block and Periarticular Injection | regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study |
| BG001 | Periarticular Injectin Alone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | some patients did not have complete data and some patients dropped out of the study after randomization. |
| 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 | Mean Visual Analog Scale (VAS) Pain Score for 2 Weeks Postoperatively | pain score 0-10 10 being more pain | Posted | Mean | Standard Deviation | score on a scale | at 2 weeks |
|
up to 1 month postop
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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 | Block and Periarticular Injection | regional anesthesia (Adductor canal block +IPACK) and Periarticular injection regional anesthesia and PAI: this is the block portion of the study PAI: this is the no block portion of the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Schneider | Washington University School of Medicine | 314-747-2511 | schneidera@wustl.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 | Feb 29, 2024 | Mar 30, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000765 | Anesthesia, Conduction |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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patients will be randomized into 2 groups.
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patients will not know which group they are in
| PAI | Drug | this is the no block portion of the study |
|
|
| Daily Step Count at 2 Weeks Postop | step count throught fitbit | 2 weeks postop |
| Oxford Knee Score | oxford knee survey through app, 0-48 scale 0 being min and 48 being max score assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment. | baseline |
| Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep | sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the baseline timepoint. | baseline % of very good sleep and fairly good sleep |
| Oxford Knee Score | oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment. | 7 days postop |
| Oxford Knee Score | oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment. | 14 days postop |
| Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep | sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 7 day timepoint. | 7 days postop % of fairly good to very good sleep |
| Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep | sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 14 day timepoint. | 14 days postop % of very good sleep to fairly good sleep |
Periarticular injection alone PAI: this is the no block portion of the study |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | the overall is patients that were originally enrolled but didn't qualify after enrolled. | Mean | Full Range | years |
|
| Sex: Female, Male | some patients did not have complete data and also withdrew from the study after randomization. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Opioid Use | opioid medications survey Opioids calculated MMEs (morphine milligram equivalents) milligrams of opioids correlates with the morphine equivalents. Morphine equivalents are standard units used to compare the analgesic potency of different opioids to a reference dose of oral morphine. They calculate total daily, safe, and effective doses | Posted | Mean | Standard Deviation | milligram morphine equivalents/MME | postop day 2 |
|
|
|
| Secondary | Daily Step Count at 2 Weeks Postop | step count throught fitbit | Posted | Mean | 95% Confidence Interval | steps per day | 2 weeks postop |
|
|
|
| Secondary | Oxford Knee Score | oxford knee survey through app, 0-48 scale 0 being min and 48 being max score assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment. | Posted | Mean | 95% Confidence Interval | score on a scale | baseline |
|
|
|
| Secondary | Sleep Quality Via Survey That Patients Completed Ranging From Very Good Sleep and Fairly Good Sleep | sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the baseline timepoint. | Posted | Count of Participants | Participants | baseline % of very good sleep and fairly good sleep |
|
|
|
| Secondary | Oxford Knee Score | oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment. | Posted | Mean | 95% Confidence Interval | score on a scale | 7 days postop |
|
|
|
| Secondary | Oxford Knee Score | oxford knee survey through app, 0-48 scale 0 being min and 48 being max assesses pain and function of the knee Score 0 to 19 May indicate severe knee arthritis requiring surgical intervention. Score 20 to 29 May indicate moderate to severe knee arthritis. Score 30 to 39 May indicate mild to moderate knee arthritis. Score 40 to 48 May indicate satisfactory joint function not requiring treatment. | Posted | Mean | 95% Confidence Interval | score on a scale | 14 days postop |
|
|
|
| Secondary | Sleep Quality Via App Surveys With Range of Very Good Sleep and Fairly Good Sleep | sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 7 day timepoint. | Posted | Count of Participants | Participants | 7 days postop % of fairly good to very good sleep |
|
|
|
| Secondary | Sleep Quality Via App Surveys With Range of Very Good Sleep to Fairly Good Sleep | sleep quality through app surveys number of participants that answered survey in the app with choices of very good sleep to very bad sleep. 0=very good sleep, 1=fairly good sleep, 2=fairly bad sleep. 3=very bad sleep the outcome measures data table reflects the number or participants that scored 0-1 on the survey at the 14 day timepoint. | Posted | Count of Participants | Participants | 14 days postop % of very good sleep to fairly good sleep |
|
|
|
| 0 |
| 70 |
| 0 |
| 70 |
| 0 |
| 70 |
| EG001 | Periarticular Injection Alone | Periarticular injection alone PAI: this is the no block portion of the study | 0 | 70 | 0 | 70 | 0 | 70 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |