Osteo Arthritis Knee
Conditions
Keywords
Total knee arthroplasty, Peri articular infiltration, Pack block, Adductor canal catheter
Brief summary
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.
Detailed description
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).
Interventions
DEVICEIpack
IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
DRUGBupivacaine
20 cc of bupivacaine(o.25%) injection
PROCEDUREPeri Articular Infiltration
Adductor Canal Catheter and Peri Articular Infiltration
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* ASA (American Society of Anesthesiology) class I-IV * age 18-75.
Exclusion criteria
* ASA class V * morbid obesity * patient refusal * patients with chronic pain or on pain medication * allergy to LA * patients receiving any additional regional techniques * coagulopathy * patients receiving systemic anticoagulation * local infection and procedures anticipated to last more than 5 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Consumption | 24 hours | Narcotic consumption in the first 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Dose of Narcotic Administration | up to 24 hours | — |
| PACU Length of Stay | average 24 hours | Post-Anesthesia Care Unit (PACU) length of stay (LOS) |
| Visual Analogue Score (VAS) for Pain | at 6, 12, 18, and 24 hours post procedure | Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain. |
| Ambulation Distance | Post-op Day 1 | Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT |
| Bartels Index | Post-op Day 1 | 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. |
| Number of Participants With Pain by Location | 24 hours | Location of knee pain as anterior/posterior, medial/lateral |
Countries
United States
Participant flow
Recruitment details
Participants enrolled from March 2018, and study conducted from June 2018 to August 2019
Participants by arm
| Arm | Count |
|---|---|
| Pai (Peri Articular) Group Patients received adductor canal catheter and peri articular infiltration. | 46 |
| 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. | 46 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 1 |
Baseline characteristics
| Characteristic | Total | Ipack Group | Pai (Peri Articular) Group |
|---|---|---|---|
| Age, Continuous | 63.66 years STANDARD_DEVIATION 7.04 | 64.67 years STANDARD_DEVIATION 7.72 | 62.65 years STANDARD_DEVIATION 6.2 |
| Alcohol Use | 29 Participants | 13 Participants | 16 Participants |
| Body Mass Index (BMI) | 32.21 kg/m^2 STANDARD_DEVIATION 6.8 | 31.74 kg/m^2 STANDARD_DEVIATION 6.34 | 32.69 kg/m^2 STANDARD_DEVIATION 7.27 |
| Education Level Bachelor's degree | 23 Participants | 11 Participants | 12 Participants |
| Education Level Graduate degree | 16 Participants | 6 Participants | 10 Participants |
| Education Level High School | 53 Participants | 29 Participants | 24 Participants |
| Number of Employed Participants | 19 Participants | 3 Participants | 16 Participants |
| Race/Ethnicity, Customized Asian | 30 Participants | 10 Participants | 20 Participants |
| Race/Ethnicity, Customized Black or African American | 30 Participants | 20 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 16 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Female | 44 Participants | 14 Participants | 30 Participants |
| Sex: Female, Male Male | 48 Participants | 32 Participants | 16 Participants |
| Side of surgery Left | 40 Participants | 20 Participants | 20 Participants |
| Side of surgery Right | 52 Participants | 26 Participants | 26 Participants |
| Smoker | 6 Participants | 5 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 46 | 0 / 46 |
| other Total, other adverse events | 0 / 46 | 0 / 46 |
| serious Total, serious adverse events | 0 / 46 | 0 / 46 |
Outcome results
Primary
Narcotic Consumption
Narcotic consumption in the first 24 hours
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ipack Group | Narcotic Consumption | 15.87 morphine equivalents, mg | Standard Deviation 19.75 |
| Pai (Peri Articular) Group | Narcotic Consumption | 13.67 morphine equivalents, mg | Standard Deviation 19.39 |
Secondary
Ambulation Distance
Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT
Time frame: Post-op Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipack Group | Ambulation Distance | 50 meters |
| Pai (Peri Articular) Group | Ambulation Distance | 45 meters |
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.
Time frame: Post-op Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipack Group | Bartels Index | 47 score on a scale |
| Pai (Peri Articular) Group | Bartels Index | 39 score on a scale |
Secondary
Number of Participants With Pain by Location
Location of knee pain as anterior/posterior, medial/lateral
Time frame: 24 hours
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ipack Group | Number of Participants With Pain by Location | Anterior | 1 Participants |
| Ipack Group | Number of Participants With Pain by Location | Lateral | 10 Participants |
| Ipack Group | Number of Participants With Pain by Location | Posterior | 4 Participants |
| Ipack Group | Number of Participants With Pain by Location | Knee | 4 Participants |
| Ipack Group | Number of Participants With Pain by Location | No Pain | 22 Participants |
| Ipack Group | Number of Participants With Pain by Location | Medial | 5 Participants |
| Pai (Peri Articular) Group | Number of Participants With Pain by Location | No Pain | 0 Participants |
| Pai (Peri Articular) Group | Number of Participants With Pain by Location | Medial | 3 Participants |
| Pai (Peri Articular) Group | Number of Participants With Pain by Location | Anterior | 0 Participants |
| Pai (Peri Articular) Group | Number of Participants With Pain by Location | Knee | 18 Participants |
| Pai (Peri Articular) Group | Number of Participants With Pain by Location | Lateral | 7 Participants |
| Pai (Peri Articular) Group | Number of Participants With Pain by Location | Posterior | 18 Participants |
Secondary
PACU Length of Stay
Post-Anesthesia Care Unit (PACU) length of stay (LOS)
Time frame: average 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipack Group | PACU Length of Stay | 3.00 hours |
| Pai (Peri Articular) Group | PACU Length of Stay | 3.00 hours |
Secondary
Time to First Dose of Narcotic Administration
Time frame: up to 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ipack Group | Time to First Dose of Narcotic Administration | 1.5 hours |
| Pai (Peri Articular) Group | Time to First Dose of Narcotic Administration | 0.25 hours |
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.
Time frame: at 6, 12, 18, and 24 hours post procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ipack Group | Visual Analogue Score (VAS) for Pain | 6 hours | 0.93 score on a scale | Standard Deviation 2.05 |
| Ipack Group | Visual Analogue Score (VAS) for Pain | 12 hours | 0.76 score on a scale | Standard Deviation 1.62 |
| Ipack Group | Visual Analogue Score (VAS) for Pain | 18 hours | 0.74 score on a scale | Standard Deviation 1.93 |
| Ipack Group | Visual Analogue Score (VAS) for Pain | 24 hours | 1.50 score on a scale | Standard Deviation 2.53 |
| Pai (Peri Articular) Group | Visual Analogue Score (VAS) for Pain | 24 hours | 2.18 score on a scale | Standard Deviation 2.51 |
| Pai (Peri Articular) Group | Visual Analogue Score (VAS) for Pain | 6 hours | 0.93 score on a scale | Standard Deviation 2.19 |
| Pai (Peri Articular) Group | Visual Analogue Score (VAS) for Pain | 18 hours | 1.41 score on a scale | Standard Deviation 2.21 |
| Pai (Peri Articular) Group | Visual Analogue Score (VAS) for Pain | 12 hours | 0.93 score on a scale | Standard Deviation 2.19 |