A Phase 4 interventional study of Ropivacaine and Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block in Knee Osteoarthritis, Primary Total Knee Arthroplasty and Physical Therapy, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Duke University · Phase 4, Interventional, and Supportive care
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.
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.
This study's enrollment of 50 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Duke University is the lead sponsor of 2,063 studies on the registry; 273 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A nerve block technique using a numbing medication called ropivacaine.
Drug: Ropivacaine · Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block
The same nerve block technique as above, however using an inactive solution of salt water.
Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block · Drug: Saline
Local anesthetic (numbing drug)
Also known as: Naropin
An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
Also known as: iPACK, Posterior Capsule
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
Also known as: Salt water placebo
Number of Participants Able to Hyperextend the Knee After Surgery
Ability to hyperextend the knee after surgery
Time frame: Within 8 hours
Ambulation as Measured by Distance Walked After Surgery
Time frame: Post-operative Day 0
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
Cumulative Opioid Consumption
Total amount of opioids used
Time frame: 24 hours
| Milestone | iPACK Block Group | Sham Group |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
Ability to hyperextend the knee after surgery
| Participants | iPACK Block Group | Sham Group |
|---|---|---|
| Number of Participants Able to Hyperextend the Knee After Surgery | 4 | 3 |
| feet | iPACK Block Group | Sham Group |
|---|---|---|
| Ambulation as Measured by Distance Walked After Surgery | 120.36 ± 123.1 | 148.8 ± 108.4 |
The 11-point numeric rating scale ranges from 0 ("no pain") to 10 ("worst pain imaginable").
| score on a scale | iPACK Block Group | Sham Group |
|---|---|---|
| Pain as Measure by Numerical Rating Scale (NRS) 11 | 4.64 ± 2.74 | 5 ± 2.2 |
Total amount of opioids used
| IV morphine equivalents | iPACK Block Group | Sham Group |
|---|---|---|
| Cumulative Opioid Consumption | 47.52 ± 39.54 | 48.98 ± 36.3 |
Collected over From enrollment in study until 24 hours post-op.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iPACK Block Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Sham Group | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Categorical(Participants) | iPACK Block Group | Sham Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 11 | 19 |
| >=65 years | 17 | 14 | 31 |
| Age, Continuous(years) | iPACK Block Group | Sham Group | Total |
|---|---|---|---|
| Mean | 66.84 ± 6.39 | 64.59 ± 7.01 | 65.71 ± 6.73 |
| Sex: Female, Male(Participants) | iPACK Block Group | Sham Group | Total |
|---|---|---|---|
| Female | 15 | 13 | 28 |
| Male | 10 | 12 | 22 |
| Ethnicity (NIH/OMB)(Participants) | iPACK Block Group | Sham Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 25 | 25 | 50 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | iPACK Block Group | Sham Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 2 | 7 |
| White | 20 | 23 | 43 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | iPACK Block Group | Sham Group | Total |
|---|---|---|---|
| United States | 25 | 25 | 50 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Ran from May 2018 to primary completion in Jan 2021, 32 months.
Results were first posted in Dec 2021, 10 months after primary completion.
Of 88 non-industry phase 4 interventional studies under Osteoarthritis, Knee, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 32. This study's 32 months is above that.
Counting every sponsor, half of 97 studies reached it within 19 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine