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A comparison of two pain control methods - the combination of Adductor Canal Block (ACB)/Periarticular Injection (PAI)/Infiltration of the interspace between the popliteal artery and the capsule of the posterior knee (IPACK) versus the Periarticular Injection (PAI) - in patients undergoing total knee arthroplasty. Primary outcome is NRS pain scores with ambulation on postoperative day one (24 hours post-block administration).
Total knee arthroplasties (TKA) are severely painful surgeries that require optimal pain control to ensure expeditious recovery and discharge. Nerve blocks, such as the femoral and sciatic nerves, are instrumental in effectively providing pain relief and improving patient satisfaction. However, though pain scores notably decreased with the introduction of nerve blocks, motor blockade rendered these patients immobile and may pose a fall risk early in the post-operative period. The advent of ultrasound introduces newer block techniques with adequate analgesia without the cost of motor blockade.
The adductor canal block serves as an alternative to the femoral or sciatic nerve blocks in providing anterior knee analgesia without significantly compromising quadriceps strength. However, patients' posterior knee compartment remains an issue for pain control. Sciatic and posterior tibial nerve blocks were implemented but again, results in motor blockade. A small percentage of sciatic nerve block cases also exhibit foot drop due to peroneal nerve injury. Alternatively, as a sensory block, the periarticular injection (PAI) proves to hasten ambulation and recovery after TKA. The PAI blind injection into the posterior capsule seems to aid in pain control of the posterior compartment and reduces the total number physical therapy sessions.
Injection in the interspace between the Popliteal Artery and Capsule of the posterior Knee (IPACK) provides an alternative to the PAI blind technique for analgesia in the posterior compartment. The IPACK block is not a nerve block, but rather infiltrates the area between the popliteal artery and femur. This area is rich with sensory nerve fibers from the posterior capsule of the knee, which originates from the sciatic and posterior tibial nerve. In this prospective study, we will compare pain scores between the three groups: ACB/PAI/IPACK, ACB/IPACK and PAI only. We will determine whether there is a difference between groups in NRS pain score with ambulation 24 hours post block administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-Articular Injections only | Active Comparator | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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| Peri-Articular Injections, Adductor Canal Block, and IPACK | Experimental | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine with epinephrine | Drug | bupivacaine 0.5% with epinephrine 30cc |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Scores | Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration. Min = 0, no pain Max = 10, worst imaginable pain | 24 hours post block administration |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption | Opioid consumption at different intervals. Although collected at different time points, the average amount of opioid across all the time points was calculated and reported. | 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 |
| Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David H Kim, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital For Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30234517 | Derived | Kim DH, Beathe JC, Lin Y, YaDeau JT, Maalouf DB, Goytizolo E, Garnett C, Ranawat AS, Su EP, Mayman DJ, Memtsoudis SG. Addition of Infiltration Between the Popliteal Artery and the Capsule of the Posterior Knee and Adductor Canal Block to Periarticular Injection Enhances Postoperative Pain Control in Total Knee Arthroplasty: A Randomized Controlled Trial. Anesth Analg. 2019 Aug;129(2):526-535. doi: 10.1213/ANE.0000000000003794. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peri-Articular Injections Only | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Jan 24, 2017 |
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| Methylprednisolone | Drug | 40 mg/ml, 1 ml |
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| Cefazolin | Drug | 500 mg in 10 ml |
|
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| 8 MHz. Chiba needle | Device | 22G/ 4 inches |
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| Bupivacaine with Dexamethasone | Drug | 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone |
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| Bupivacaine 25cc | Drug | 25 cc 0.25% bupivacaine |
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| Bupivacaine 20cc | Drug | 20cc 0.25% bupivacaine |
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| Dexamethasone | Drug | 2 mg IV dexamethasone. |
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Numeric Rating Scale (NRS) Pain scores at rest and with movement at different intervals Min = 0, no pain Max = 10, worst imaginable pain Despite being collected at various times, the average pain score across all time points was calculated and reported. |
| 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 |
| Ambulation Distance During Physical Therapy | The distance patients were able to walked during physical therapy ambulation. Measured in feet. The average distance that patients walked at each time point was calculated and reported for the number of participants analyzed. | It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 |
| Level of Patient Satisfaction With Postoperative Pain Management | Patient satisfaction with their postoperative pain management. Measured on a scale of 0 to 10, with 0 meaning extremely dissatisfied and 10 meaning extremely satisfied. | Post-Operative Day 2 |
| Pain Outcomes | The Pain Outcomes (PainOUT) questionnaire was used to assess postoperative pain, psychological variables associated with pain, opioid consumption, satisfaction, and side effects. Scored on 3 scales of 0 to 10, depending on each individual question: 0 = no pain, 10 = worst pain imaginable 0 = did not interfere, 10 = completely interfered 0 = not at all, 10 = extremely Although measured across different timepoints, the average score of all participants was calculated and reported. | Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported |
| Hospital Length of Stay | The patients' Length of Stay (LOS) at the hospital will be calculate with the time the patient entered the post-operative care unit being the "begin time" and the time patient was discharged being the "end time." The "end time" will differ for each patient depending on which day (post-operative day 1, post-operative day 2, or post-operative day 3) they were discharged. The average length of stay for all patients (reported in minutes) will be reported. | Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3 |
| Opioid Related Symptom Distress Scale (ORSDS) | ORSDS scores. A lower score is a better outcome. range is 0 to 4. | Post-Operative Day 1 and Post-Operative Day 2 |
| Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | This is a patient-reported joint-specific score used to assess outcomes following total knee arthroplasty. Scores range from 0 to 100, with 0 representing total knee disability and 100 representing perfect knee health. Higher score means better outcome. The average score for each time point is reported for each arm. | Measured at pre-operation (day of surgery) and 6 weeks post-operation |
| FG001 | Peri-Articular Injections, Adductor Canal Block, and IPACK | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Peri-Articular Injections Only | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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| BG001 | Peri-Articular Injections, Adductor Canal Block, and IPACK | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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| BG002 | Total | Total of all reporting groups |
| 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, Categorical | Count of Participants | Participants | No |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | cm |
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| Weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| ASA status | The purpose of an ASA score is to assess and communicate a patient's pre-anesthesia medical co-morbidities. Assigning an ASA level is a clinical decision based on multiple factors. While the ASA classification may initially be determined at various times during the preoperative assessment of the patient, the final assignment of ASA is made on the day of anesthesia care by the anesthesiologist after evaluating the patient. ASA I: A normal healthy patient. ASA II: A patient with mild systemic disease. ASA III: A patient with severe systemic disease. | Count of Participants | Participants |
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| 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 | Numeric Rating Scale (NRS) Pain Scores | Numeric Rating Scale (NRS) Pain scores with ambulation 24 hours post block administration. Min = 0, no pain Max = 10, worst imaginable pain | Posted | Mean | Standard Deviation | score on a scale | 24 hours post block administration |
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| Secondary | Opioid Consumption | Opioid consumption at different intervals. Although collected at different time points, the average amount of opioid across all the time points was calculated and reported. | Posted | Mean | Standard Deviation | oral morphine equivalents (mg) | 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Numeric Rating Scale (NRS) Pain Scores at Rest and With Movement | Numeric Rating Scale (NRS) Pain scores at rest and with movement at different intervals Min = 0, no pain Max = 10, worst imaginable pain Despite being collected at various times, the average pain score across all time points was calculated and reported. | Posted | Mean | Standard Deviation | score on a scale | 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 |
| |||||||||||||||||||||||||||||||
| Secondary | Ambulation Distance During Physical Therapy | The distance patients were able to walked during physical therapy ambulation. Measured in feet. The average distance that patients walked at each time point was calculated and reported for the number of participants analyzed. | some patients were discharged or unable to ambulate during time point. | Posted | Mean | Standard Deviation | feet | It will be assessed on 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, and 72 hours on Post-Operative Day 3 |
| ||||||||||||||||||||||||||||||
| Secondary | Level of Patient Satisfaction With Postoperative Pain Management | Patient satisfaction with their postoperative pain management. Measured on a scale of 0 to 10, with 0 meaning extremely dissatisfied and 10 meaning extremely satisfied. | Because patients were not reachable for follow-up on post-operative day 2, the total number of participants analyzed for this outcome was reduced. | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 2 |
| ||||||||||||||||||||||||||||||
| Secondary | Pain Outcomes | The Pain Outcomes (PainOUT) questionnaire was used to assess postoperative pain, psychological variables associated with pain, opioid consumption, satisfaction, and side effects. Scored on 3 scales of 0 to 10, depending on each individual question: 0 = no pain, 10 = worst pain imaginable 0 = did not interfere, 10 = completely interfered 0 = not at all, 10 = extremely Although measured across different timepoints, the average score of all participants was calculated and reported. | Because patients were not reachable for follow-up on post-operative day 2, the total number of participants analyzed for this outcome was reduced. | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 1 and Post-Operative Day 2, average across the two time points reported |
| ||||||||||||||||||||||||||||||
| Secondary | Hospital Length of Stay | The patients' Length of Stay (LOS) at the hospital will be calculate with the time the patient entered the post-operative care unit being the "begin time" and the time patient was discharged being the "end time." The "end time" will differ for each patient depending on which day (post-operative day 1, post-operative day 2, or post-operative day 3) they were discharged. The average length of stay for all patients (reported in minutes) will be reported. | Posted | Median | Inter-Quartile Range | minutes | Assessed at either: 24 hours on Post-Operative Day 1, 48 hours on Post-Operative Day 2, or 72 hours on Post-Operative Day 3 |
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| Secondary | Opioid Related Symptom Distress Scale (ORSDS) | ORSDS scores. A lower score is a better outcome. range is 0 to 4. | some patients did not answer questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Post-Operative Day 1 and Post-Operative Day 2 |
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| Secondary | Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) | This is a patient-reported joint-specific score used to assess outcomes following total knee arthroplasty. Scores range from 0 to 100, with 0 representing total knee disability and 100 representing perfect knee health. Higher score means better outcome. The average score for each time point is reported for each arm. | Because patients were not reachable for follow-up at 6 weeks post-surgery, the total number of participants analyzed for this outcome was reduced. | Posted | Mean | Standard Deviation | score on a scale | Measured at pre-operation (day of surgery) and 6 weeks post-operation |
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Patients were monitored while at the hospital (up to post-operative day 3) and contacted followed up (up to 6-weeks) after their surgery day. Any adverse events that occurred over this time period were documented.
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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 | Peri-Articular Injections Only | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
| 0 | 43 | 0 | 43 | 0 | 43 |
| EG001 | Peri-Articular Injections, Adductor Canal Block, and IPACK | Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
| 0 | 43 | 0 | 43 | 0 | 43 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Kim | Hospital for Special Surgery, Anesthesiology | 2126061036 | kimd@hss.edu |
| Jan 18, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D004837 | Epinephrine |
| D008775 | Methylprednisolone |
| D000077555 | Methylprednisolone Acetate |
| D008776 | Methylprednisolone Hemisuccinate |
| D002437 | Cefazolin |
| D002511 | Cephalosporins |
| D003907 | Dexamethasone |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001557 | Benzenesulfonates |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| ASA II |
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| ASA III |
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| OG001 |
| Peri-Articular Injections, Adductor Canal Block, and IPACK |
Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
Injection prior to cementation a. bupivacaine 0.25% with epinephrine 30cc; b. methylprednisolone, 40 mg/ml, 1 ml c. cefazolin, 500 mg in 10 ml d. normal saline, 22cc
Superficial injection prior to closure.
a. 20cc 0.25% bupivacaine
Adductor canal block technique (supine position, post IV sedation) a. Mid-thigh injection of 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
IPACK technique (supine position)
25 cc 0.25% bupivacaine
Bupivacaine: 0.5% with epinephrine 30cc
Methylprednisolone: 40 mg/ml, 1 ml
Cefazolin: 500 mg in 10 ml
8 MHz. Chiba needle: 22G/ 4 inches
15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone: 15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
25 cc 0.25% bupivacaine: 25 cc 0.25% bupivacaine
20cc 0.25% bupivacaine: 20cc 0.25% bupivacaine
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Combined spinal epidural anesthetic with 1.5% Mepivacaine (60mg)
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