Knee OsteoarthritisPhase 4NCT03353233
Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
A Phase 4 study testing Ropivacaine, Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block and Saline in people with Knee Osteoarthritis and Primary Total Knee Arthroplasty, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Knee Osteoarthritis, Primary Total Knee Arthroplasty, Physical Therapy
- What is being tested?
- Ropivacaine, Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block and Saline
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2018to 23 Jan 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- Between 18 and 75 years old
- American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27713
About this study
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.
- Conditions
- Knee Osteoarthritis, Primary Total Knee Arthroplasty, Physical Therapy, Pain, Knee Extension
- Being tested
- Ropivacaine, Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block, Saline
- Keywords
- iPACK, Interspace between the Popliteal Artery and Capsule of the Knee, Posterior Capsule block, Nerve Block
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
Local anesthetic (numbing drug)
Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) BlockProcedure or surgery
Also called iPACK, Posterior Capsule
An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
SalineDrug
Also called Salt water placebo
An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
| Study group | Role | What they receive |
|---|---|---|
| iPACK Block Group | Experimental | A nerve block technique using a numbing medication called ropivacaine. Receives: Drug: Ropivacaine; Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block |
| Sham Group | Placebo comparator | The same nerve block technique as above, however using an inactive solution of salt water. Receives: Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Able to Hyperextend the Knee After Surgery
Ability to hyperextend the knee after surgery
Measured: Within 8 hours
Secondary outcomes (3)
Ambulation as Measured by Distance Walked After Surgery
Measured: 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").
Measured: 24 hours
Cumulative Opioid Consumption
Total amount of opioids used
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start3 May 2018
- Primary completion22 Jan 2021
- Study completion23 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353233
- Sponsor's protocol ID
- Pro00070573
- Status last verified
- Nov 2021
- First submitted
- 21 Nov 2017
- Last updated
- 21 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Utility of Ultrasound Guided iPACK Block for Knee Extension After Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT03353233
- Acronym / sponsor ID
- Pro00070573
- Conditions
- Knee Osteoarthritis, Primary Total Knee Arthroplasty, Physical Therapy, Pain, Knee Extension
- Keywords
- iPACK, Interspace between the Popliteal Artery and Capsule of the Knee, Posterior Capsule block, Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 3 May 2018 (actual)
- Primary completion
- 22 Jan 2021 (actual)
- Study completion
- 23 Jan 2021 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Posted 21 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iPACK Block Group | Experimental | Drug: Ropivacaine, Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) BlockA nerve block technique using a numbing medication called ropivacaine. |
| Sham Group | Placebo comparator | Procedure: Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block, Drug: SalineThe same nerve block technique as above, however using an inactive solution of salt water. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- Between 18 and 75 years old
- American Society of Anesthesiologists (ASA) 1-3 patients undergoing primary total knee arthroplasty
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: NaropinLocal anesthetic (numbing drug) | Drug | iPACK Block Group |
| Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) BlockAlso: iPACK, Posterior CapsuleAn ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee. | Procedure or surgery | Sham Group, iPACK Block Group |
| SalineAlso: Salt water placeboAn ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water. | Drug | Sham Group |
Primary outcome
Number of Participants Able to Hyperextend the Knee After Surgery
Time frame: Within 8 hours
Ability to hyperextend the knee after surgery
3 secondary outcomes
Ambulation as Measured by Distance Walked After Surgery
Time frame: Post-operative Day 0
Pain as Measure by Numerical Rating Scale (NRS) 11
Time frame: 24 hours
Cumulative Opioid Consumption
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine, Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block and Saline in people with Knee Osteoarthritis and Primary Total Knee Arthroplasty, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Able to Hyperextend the Knee After Surgery (time frame: Within 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.