Knee Extension, Knee Osteoarthritis, Pain, Physical Therapy, Primary Total Knee Arthroplasty
Conditions
Keywords
iPACK, Interspace between the Popliteal Artery and Capsule of the Knee, Posterior Capsule block, Nerve Block
Brief summary
The purpose of this study is to learn if using an Interspace between the Popliteal Artery and Capsule of the Knee (iPACK) injection technique (also called a nerve block) that numbs the nerves going to the back part of the knee to aid in physical therapy after surgery. The iPACK technique uses a numbing solution (local anesthetics) that is injected behind the knee to reduce pain and to help straighten the knee. This block may affect movement in the leg and make the legs weak, but thing is rare. A few institutions use the iPACK block for patients having total knee replacements, with the hope of providing good pain relief combined with improved mobility after surgery.
Interventions
DRUGRopivacaine
Local anesthetic (numbing drug)
PROCEDUREInterspace 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.
DRUGSaline
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* English speaking * Between 18 and 75 years old * American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty
Exclusion criteria
* ASA 4 or 5 * Revision knee arthroplasty * Diagnosis of chronic pain * Daily chronic opioid use (over 3 months of continuous opioid use) * Inability to communicate pain scores or need for analgesia * Acute knee dislocation/fracture * Infection at the site of block placement * Age under 18 years old or greater than 75 years old * Pregnant women * Intolerance/allergy to local anesthetics * Weight \<50 kg * Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years. * Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance * Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Able to Hyperextend the Knee After Surgery | Within 8 hours | Ability to hyperextend the knee after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ambulation as Measured by Distance Walked After Surgery | Post-operative Day 0 | — |
| Pain as Measure by Numerical Rating Scale (NRS) 11 | 24 hours | The 11-point numeric rating scale ranges from 0 (no pain) to 10 (worst pain imaginable). |
| Cumulative Opioid Consumption | 24 hours | Total amount of opioids used |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 25 |
| 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. | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Sham Group | Total | iPACK Block Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 31 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 19 Participants | 8 Participants |
| Age, Continuous | 64.59 years STANDARD_DEVIATION 7.01 | 65.71 years STANDARD_DEVIATION 6.73 | 66.84 years STANDARD_DEVIATION 6.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 50 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 43 Participants | 20 Participants |
| Region of Enrollment United States | 25 Participants | 50 Participants | 25 Participants |
| Sex: Female, Male Female | 13 Participants | 28 Participants | 15 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Number of Participants Able to Hyperextend the Knee After Surgery
Ability to hyperextend the knee after surgery
Time frame: Within 8 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| iPACK Block Group | Number of Participants Able to Hyperextend the Knee After Surgery | 4 Participants |
| Sham Group | Number of Participants Able to Hyperextend the Knee After Surgery | 3 Participants |
Secondary
Ambulation as Measured by Distance Walked After Surgery
Time frame: Post-operative Day 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iPACK Block Group | Ambulation as Measured by Distance Walked After Surgery | 120.36 feet | Standard Deviation 123.1 |
| Sham Group | Ambulation as Measured by Distance Walked After Surgery | 148.8 feet | Standard Deviation 108.4 |
Secondary
Cumulative Opioid Consumption
Total amount of opioids used
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iPACK Block Group | Cumulative Opioid Consumption | 47.52 IV morphine equivalents | Standard Deviation 39.54 |
| Sham Group | Cumulative Opioid Consumption | 48.98 IV morphine equivalents | Standard Deviation 36.3 |
Secondary
Pain as Measure by Numerical Rating Scale (NRS) 11
The 11-point numeric rating scale ranges from 0 (no pain) to 10 (worst pain imaginable).
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| iPACK Block Group | Pain as Measure by Numerical Rating Scale (NRS) 11 | 4.64 score on a scale | Standard Deviation 2.74 |
| Sham Group | Pain as Measure by Numerical Rating Scale (NRS) 11 | 5 score on a scale | Standard Deviation 2.2 |