Trial Outcomes & Findings for Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty (NCT NCT03653416)
NCT ID: NCT03653416
Last Updated: 2020-11-03
Results Overview
Narcotic consumption in the first 24 hours
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
99 participants
Primary outcome timeframe
24 hours
Results posted on
2020-11-03
Participant Flow
Participants enrolled from March 2018, and study conducted from June 2018 to August 2019
Participant milestones
| Measure |
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.
|
Pai (Peri Articular) Group
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
47
|
|
Overall Study
COMPLETED
|
46
|
46
|
|
Overall Study
NOT COMPLETED
|
6
|
1
|
Reasons for withdrawal
| Measure |
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.
|
Pai (Peri Articular) Group
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
6
|
1
|
Baseline Characteristics
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
Baseline characteristics by cohort
| Measure |
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
Ipack Group
n=46 Participants
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.
|
Total
n=92 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.65 years
STANDARD_DEVIATION 6.20 • n=5 Participants
|
64.67 years
STANDARD_DEVIATION 7.72 • n=7 Participants
|
63.66 years
STANDARD_DEVIATION 7.04 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
32.69 kg/m^2
STANDARD_DEVIATION 7.27 • n=5 Participants
|
31.74 kg/m^2
STANDARD_DEVIATION 6.34 • n=7 Participants
|
32.21 kg/m^2
STANDARD_DEVIATION 6.80 • n=5 Participants
|
|
Side of surgery
Left
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Side of surgery
Right
|
26 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Smoker
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Alcohol Use
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Education Level
High School
|
24 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Education Level
Bachelor's degree
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Education Level
Graduate degree
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Number of Employed Participants
|
16 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursNarcotic consumption in the first 24 hours
Outcome measures
| Measure |
Ipack Group
n=46 Participants
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.
|
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Narcotic Consumption
|
15.87 morphine equivalents, mg
Standard Deviation 19.75
|
13.67 morphine equivalents, mg
Standard Deviation 19.39
|
SECONDARY outcome
Timeframe: at 6, 12, 18, and 24 hours post procedureVisual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain.
Outcome measures
| Measure |
Ipack Group
n=46 Participants
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.
|
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Visual Analogue Score (VAS) for Pain
6 hours
|
0.93 score on a scale
Standard Deviation 2.05
|
0.93 score on a scale
Standard Deviation 2.19
|
|
Visual Analogue Score (VAS) for Pain
12 hours
|
0.76 score on a scale
Standard Deviation 1.62
|
0.93 score on a scale
Standard Deviation 2.19
|
|
Visual Analogue Score (VAS) for Pain
18 hours
|
0.74 score on a scale
Standard Deviation 1.93
|
1.41 score on a scale
Standard Deviation 2.21
|
|
Visual Analogue Score (VAS) for Pain
24 hours
|
1.50 score on a scale
Standard Deviation 2.53
|
2.18 score on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: up to 24 hoursOutcome measures
| Measure |
Ipack Group
n=46 Participants
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.
|
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Time to First Dose of Narcotic Administration
|
1.5 hours
Interval 0.0 to 7.0
|
0.25 hours
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: average 24 hoursPost-Anesthesia Care Unit (PACU) length of stay (LOS)
Outcome measures
| Measure |
Ipack Group
n=46 Participants
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.
|
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
PACU Length of Stay
|
3.00 hours
Interval 2.5 to 4.51
|
3.00 hours
Interval 3.0 to 5.0
|
SECONDARY outcome
Timeframe: 24 hoursLocation of knee pain as anterior/posterior, medial/lateral
Outcome measures
| Measure |
Ipack Group
n=46 Participants
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.
|
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Number of Participants With Pain by Location
Anterior
|
1 Participants
|
0 Participants
|
|
Number of Participants With Pain by Location
Knee
|
4 Participants
|
18 Participants
|
|
Number of Participants With Pain by Location
Lateral
|
10 Participants
|
7 Participants
|
|
Number of Participants With Pain by Location
Medial
|
5 Participants
|
3 Participants
|
|
Number of Participants With Pain by Location
Posterior
|
4 Participants
|
18 Participants
|
|
Number of Participants With Pain by Location
No Pain
|
22 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Post-op Day 1Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT
Outcome measures
| Measure |
Ipack Group
n=46 Participants
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.
|
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Ambulation Distance
|
50 meters
Interval 30.0 to 74.0
|
45 meters
Interval 15.0 to 100.0
|
SECONDARY outcome
Timeframe: Post-op Day 1Bartels 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.
Outcome measures
| Measure |
Ipack Group
n=46 Participants
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.
|
Pai (Peri Articular) Group
n=46 Participants
Patients received adductor canal catheter and peri articular infiltration.
|
|---|---|---|
|
Bartels Index
|
47 score on a scale
Interval 38.0 to 53.0
|
39 score on a scale
Interval 38.0 to 53.0
|
Adverse Events
Ipack Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pai (Peri Articular) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Poonam Pai B. H
Icahn School of Medicine at Mount Sinai
Phone: 347-569-4816
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER