Trial Outcomes & Findings for Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty. (NCT NCT03353233)
NCT ID: NCT03353233
Last Updated: 2021-12-21
Results Overview
Ability to hyperextend the knee after surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Within 8 hours
Results posted on
2021-12-21
Participant Flow
Participant milestones
| Measure |
iPACK Block Group
A nerve block technique using a numbing medication called ropivacaine.
Ropivacaine: Local anesthetic (numbing drug)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
|
Sham Group
The same nerve block technique as above, however using an inactive solution of salt water.
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
Baseline characteristics by cohort
| Measure |
iPACK Block Group
n=25 Participants
A nerve block technique using a numbing medication called ropivacaine.
Ropivacaine: Local anesthetic (numbing drug)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
|
Sham Group
n=25 Participants
The same nerve block technique as above, however using an inactive solution of salt water.
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Continuous
|
66.84 years
STANDARD_DEVIATION 6.39 • n=5 Participants
|
64.59 years
STANDARD_DEVIATION 7.01 • n=7 Participants
|
65.71 years
STANDARD_DEVIATION 6.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 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 (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 8 hoursAbility to hyperextend the knee after surgery
Outcome measures
| Measure |
iPACK Block Group
n=25 Participants
A nerve block technique using a numbing medication called ropivacaine.
Ropivacaine: Local anesthetic (numbing drug)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
|
Sham Group
n=25 Participants
The same nerve block technique as above, however using an inactive solution of salt water.
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
|
|---|---|---|
|
Number of Participants Able to Hyperextend the Knee After Surgery
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Post-operative Day 0Outcome measures
| Measure |
iPACK Block Group
n=25 Participants
A nerve block technique using a numbing medication called ropivacaine.
Ropivacaine: Local anesthetic (numbing drug)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
|
Sham Group
n=25 Participants
The same nerve block technique as above, however using an inactive solution of salt water.
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
|
|---|---|---|
|
Ambulation as Measured by Distance Walked After Surgery
|
120.36 feet
Standard Deviation 123.1
|
148.8 feet
Standard Deviation 108.4
|
SECONDARY outcome
Timeframe: 24 hoursThe 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").
Outcome measures
| Measure |
iPACK Block Group
n=25 Participants
A nerve block technique using a numbing medication called ropivacaine.
Ropivacaine: Local anesthetic (numbing drug)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
|
Sham Group
n=25 Participants
The same nerve block technique as above, however using an inactive solution of salt water.
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
|
|---|---|---|
|
Pain as Measure by Numerical Rating Scale (NRS) 11
|
4.64 score on a scale
Standard Deviation 2.74
|
5 score on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 24 hoursTotal amount of opioids used
Outcome measures
| Measure |
iPACK Block Group
n=25 Participants
A nerve block technique using a numbing medication called ropivacaine.
Ropivacaine: Local anesthetic (numbing drug)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
|
Sham Group
n=25 Participants
The same nerve block technique as above, however using an inactive solution of salt water.
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block: An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Saline: An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
|
|---|---|---|
|
Cumulative Opioid Consumption
|
47.52 IV morphine equivalents
Standard Deviation 39.54
|
48.98 IV morphine equivalents
Standard Deviation 36.3
|
Adverse Events
iPACK Block Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham 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
W. Michael Bullock, MD, PhD
Duke University Medical Center
Phone: 919-681-6437
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place