Trial Outcomes & Findings for iPACK for Post-op Pain Following ACL Reconstruction (NCT NCT05498870)
NCT ID: NCT05498870
Last Updated: 2024-10-16
Results Overview
The primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
0-72 hours post op
Results posted on
2024-10-16
Participant Flow
Each participant contributed one study knee. They underwent an ACL reconstruction on one single knee to qualify for participation in the study.
Participant milestones
| Measure |
Adductor Canal Block (ACB) Only
Participants randomized to the ACB only group will receive an adductor canal block alone.
Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal
|
ACB + iPACK
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
iPACK for Post-op Pain Following ACL Reconstruction
Baseline characteristics by cohort
| Measure |
Adductor Canal Block (ACB) Only
n=34 Participants
Participants randomized to the ACB only group will receive an adductor canal block alone.
Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal
|
ACB + iPACK
n=38 Participants
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.6 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
22.8 years
STANDARD_DEVIATION 8.53 • n=7 Participants
|
22.7 years
STANDARD_DEVIATION 8.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Body Mass Index
|
25.4 kg/m^2
STANDARD_DEVIATION 3.49 • n=5 Participants
|
25.9 kg/m^2
STANDARD_DEVIATION 5.46 • n=7 Participants
|
25.7 kg/m^2
STANDARD_DEVIATION 4.63 • n=5 Participants
|
|
Preoperative VAS Pain Score
|
0 units on a scale
n=5 Participants
|
0 units on a scale
n=7 Participants
|
0 units on a scale
n=5 Participants
|
|
ACL Side
Left ACL
|
17 participants
n=5 Participants
|
16 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
ACL Side
Right ACL
|
17 participants
n=5 Participants
|
22 participants
n=7 Participants
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-72 hours post opThe primary endpoint will measure subjective pain scores using a Visual Analog Scale ranging from 0 (no pain) to 100 (severe intolerable pain) at 12-hour intervals during the first 72 hours of the postoperative window. A higher score means worse outcome.
Outcome measures
| Measure |
Adductor Canal Block (ACB) Only
n=34 Participants
Participants randomized to the ACB only group will receive an adductor canal block alone.
Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal
|
ACB + iPACK
n=38 Participants
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block
|
|---|---|---|
|
Pain Scores
Pain at Discharge
|
41.5 units on a scale
Standard Error 27.3
|
29.8 units on a scale
Standard Error 20.5
|
|
Pain Scores
12 hours post-op
|
37.9 units on a scale
Standard Error 4.22
|
47.4 units on a scale
Standard Error 4.02
|
|
Pain Scores
24 hours post-op
|
38.7 units on a scale
Standard Error 4.05
|
49.9 units on a scale
Standard Error 4.32
|
|
Pain Scores
36 hours post-op
|
40.9 units on a scale
Standard Error 4.84
|
54.7 units on a scale
Standard Error 4.35
|
|
Pain Scores
48 hours post-op
|
40.2 units on a scale
Standard Error 4.66
|
50.8 units on a scale
Standard Error 4.68
|
|
Pain Scores
60 hours post-op
|
41.1 units on a scale
Standard Error 4.39
|
44.2 units on a scale
Standard Error 4.2
|
|
Pain Scores
72 hours post-op
|
36.2 units on a scale
Standard Error 4.8
|
36.7 units on a scale
Standard Error 4.15
|
SECONDARY outcome
Timeframe: up to 72 hours post-opThe secondary endpoints will measure perioperative opioid consumption through postoperative day 2 in 12-hour intervals and converted into morphine milligram equivalents using standard conversions.
Outcome measures
| Measure |
Adductor Canal Block (ACB) Only
n=34 Participants
Participants randomized to the ACB only group will receive an adductor canal block alone.
Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal
|
ACB + iPACK
n=38 Participants
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block
|
|---|---|---|
|
Total Postoperative Opioid Consumption (Total MME)
72 hours post-op
|
6.65 morphine milligram equivalents
Standard Error 2.18
|
7.65 morphine milligram equivalents
Standard Error 2.66
|
|
Total Postoperative Opioid Consumption (Total MME)
12 hours post-op
|
8.26 morphine milligram equivalents
Standard Error 1.99
|
11.2 morphine milligram equivalents
Standard Error 1.93
|
|
Total Postoperative Opioid Consumption (Total MME)
24 hours post-op
|
6.09 morphine milligram equivalents
Standard Error 1.98
|
10.5 morphine milligram equivalents
Standard Error 2.05
|
|
Total Postoperative Opioid Consumption (Total MME)
36 hours post-op
|
10.4 morphine milligram equivalents
Standard Error 2.48
|
16.2 morphine milligram equivalents
Standard Error 2.97
|
|
Total Postoperative Opioid Consumption (Total MME)
48 hours post-op
|
6.51 morphine milligram equivalents
Standard Error 2.15
|
10.5 morphine milligram equivalents
Standard Error 2.43
|
|
Total Postoperative Opioid Consumption (Total MME)
60 hours post-op
|
10.5 morphine milligram equivalents
Standard Error 2.52
|
14.5 morphine milligram equivalents
Standard Error 2.55
|
SECONDARY outcome
Timeframe: up to two months after surgeryAn additional secondary endpoint is the range of motion, measured in degrees, of the operative knee at post-op visit 1 and 2. The post-op measurements will be compared to the pre-operative measurements. The scale of range of motion is from 0 - 135 degrees. The higher the score (degrees), the better the outcome.
Outcome measures
| Measure |
Adductor Canal Block (ACB) Only
n=34 Participants
Participants randomized to the ACB only group will receive an adductor canal block alone.
Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal
|
ACB + iPACK
n=38 Participants
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block
|
|---|---|---|
|
Range of Motion (Degrees)
|
90.0 degrees
Standard Error 2.38
|
99.3 degrees
Standard Error 2.23
|
Adverse Events
Adductor Canal Block (ACB) Only
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
ACB + iPACK
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adductor Canal Block (ACB) Only
n=34 participants at risk
Participants randomized to the ACB only group will receive an adductor canal block alone.
Adductor Canal Block (ACB) Only: Patients will receive an ACB with lidocaine skin wheal
|
ACB + iPACK
n=38 participants at risk
Participants randomized to the ACB + iPACK group will receive both the ACB and iPACK block.
Adductor Canal Block (ACB) + iPACK Block: Patients will receive an ACB with iPACK block
|
|---|---|---|
|
Injury, poisoning and procedural complications
Nerve Block Adverse Event
|
5.9%
2/34 • Number of events 2 • Adverse events were collected from the time randomization occurred through the end of post-op Day 3, an average of 4 days.
Patients self reported if they developed any type of nerve-block related adverse event such as nerve damage, local anesthetic systemic toxicity (LAST), numbness, or infection at injection site, etc. Additionally, they also self-reported if they had any surgical adverse events such as incision infection. All patient-reported adverse events were followed up on to confirm reported details.
|
7.9%
3/38 • Number of events 3 • Adverse events were collected from the time randomization occurred through the end of post-op Day 3, an average of 4 days.
Patients self reported if they developed any type of nerve-block related adverse event such as nerve damage, local anesthetic systemic toxicity (LAST), numbness, or infection at injection site, etc. Additionally, they also self-reported if they had any surgical adverse events such as incision infection. All patient-reported adverse events were followed up on to confirm reported details.
|
|
Surgical and medical procedures
Surgical Adverse Event
|
11.8%
4/34 • Number of events 4 • Adverse events were collected from the time randomization occurred through the end of post-op Day 3, an average of 4 days.
Patients self reported if they developed any type of nerve-block related adverse event such as nerve damage, local anesthetic systemic toxicity (LAST), numbness, or infection at injection site, etc. Additionally, they also self-reported if they had any surgical adverse events such as incision infection. All patient-reported adverse events were followed up on to confirm reported details.
|
13.2%
5/38 • Number of events 5 • Adverse events were collected from the time randomization occurred through the end of post-op Day 3, an average of 4 days.
Patients self reported if they developed any type of nerve-block related adverse event such as nerve damage, local anesthetic systemic toxicity (LAST), numbness, or infection at injection site, etc. Additionally, they also self-reported if they had any surgical adverse events such as incision infection. All patient-reported adverse events were followed up on to confirm reported details.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place