Osteo Arthritis KneePhase 4NCT03653416
Efficacy of Ipack Block and Surgeon's Joint Infiltration in Total Knee Arthroplasty
A Phase 4 study testing Ipack, Bupivacaine and Peri Articular Infiltration in people with Osteo Arthritis Knee, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Ipack, Bupivacaine and Peri Articular Infiltration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Aug 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiology) class I-IV
- age 18-75.
Who cannot join
- ASA class V
- morbid obesity
- patient refusal
- patients with chronic pain or on pain medication
- allergy to LA
- patients receiving any additional regional techniques
Show all 9Show fewer
- coagulopathy
- patients receiving systemic anticoagulation
- local infection and procedures anticipated to last more than 5 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial
Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.
Read the detailed description
There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).
- Conditions
- Osteo Arthritis Knee
- Being tested
- Ipack, Bupivacaine, Peri Articular Infiltration
- Keywords
- Total knee arthroplasty, Peri articular infiltration, Pack block, Adductor canal catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpackDevice
IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
BupivacaineDrug
20 cc of bupivacaine(o.25%) injection
Peri Articular InfiltrationProcedure or surgery
Also called PAI
Adductor Canal Catheter and Peri Articular Infiltration
| Study group | Role | What they receive |
|---|---|---|
| Ipack group | Experimental | 20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well. Receives: Device: Ipack; Drug: Bupivacaine; Procedure: Peri Articular Infiltration |
| Pai (peri articular) group | Active comparator | Patients will receive adductor canal catheter and peri articular infiltration. Receives: Procedure: Peri Articular Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Narcotic Consumption
Narcotic consumption in the first 24 hours
Measured: 24 hours
Secondary outcomes (6)
Visual Analogue Score (VAS) for Pain
Visual Analogue Score (VAS) for pain - scored from 0 (no pain) to 10 (extreme pain), that is, higher score indicates more pain.
Measured: at 6, 12, 18, and 24 hours post procedure
Time to First Dose of Narcotic Administration
Measured: up to 24 hours
PACU Length of Stay
Post-Anesthesia Care Unit (PACU) length of stay (LOS)
Measured: average 24 hours
Number of Participants With Pain by Location
Location of knee pain as anterior/posterior, medial/lateral
Measured: 24 hours
Ambulation Distance
Ambulation distance with assistance on Post-operative Day (POD) 1 as assessed by PT
Measured: Post-op Day 1
Bartels Index
Bartels Index to measure activities of daily living (ADL's) on POD 1 as assessed by OT. Total possible scores range from 0-100, with higher scores indicating more independence.
Measured: Post-op Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Mar 2018
- Primary completion1 Aug 2019
- Study completion1 Aug 2019
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Lai, Icahn School of Medicine at Mount Sinai
- Investigators
- Yan H Lai, MD,MPH, Principal investigator, Ichan School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03653416
- Sponsor's protocol ID
- GCO 17-04304
- Other IDs
- IRB 17-01981
- Status last verified
- Oct 2020
- First submitted
- 28 Aug 2018
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
PubMed 29721648Bh PP, Jinadu S, Okunlola O, Darkzali H, Lin HM, Lai YH. Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. J Knee Surg. 2023 Oct;36(12):1289-1296. doi: 10.1055/s-0042-1755355. Epub 2022 Aug 9.
PubMed 35944566
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ipack Block and Periarticular Infiltration in Total Knee Arthroplasty - a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT03653416
- Acronym / sponsor ID
- GCO 17-04304
- Conditions
- Osteo Arthritis Knee
- Keywords
- Total knee arthroplasty, Peri articular infiltration, Pack block, Adductor canal catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Posted 3 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee arthroplasty(TKA) is an effective modality for the treatment of advanced osteoarthritis of the knee joint with excellent outcomes. With 719,000 cases being performed as of 2010, the incidence is expected to increase up to 3.48 million procedures annually by 2030.
Detailed description
There have been several studies regarding efficacy of peri articular infiltration. IPACK block is a novel technique gaining popularity where one injects local anesthesia safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
There have been no studies till date comparing the efficacy between IPACK block and Periarticular Infiltration (PAI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipack group | Experimental | Device: Ipack, Drug: Bupivacaine, Procedure: Peri Articular Infiltration20 cc of bupivacaine(o.25%) will be injected with the help of ultrasound guidance. Patients will receive adductor canal catheter and peri articular infiltration as well. |
| Pai (peri articular) group | Active comparator | Procedure: Peri Articular InfiltrationPatients will receive adductor canal catheter and peri articular infiltration. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiology) class I-IV
- age 18-75.
Key exclusion criteria (9 listed)
- ASA class V
- morbid obesity
- patient refusal
- patients with chronic pain or on pain medication
- allergy to LA
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 |
|---|---|---|
| IpackIPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee. | Device | Ipack group |
| Bupivacaine20 cc of bupivacaine(o.25%) injection | Drug | Ipack group |
| Peri Articular InfiltrationAlso: PAIAdductor Canal Catheter and Peri Articular Infiltration | Procedure or surgery | Ipack group, Pai (peri articular) group |
Primary outcome
Narcotic Consumption
Time frame: 24 hours
Narcotic consumption in the first 24 hours
6 secondary outcomes
Visual Analogue Score (VAS) for Pain
Time frame: at 6, 12, 18, and 24 hours post procedure
Time to First Dose of Narcotic Administration
Time frame: up to 24 hours
PACU Length of Stay
Time frame: average 24 hours
Number of Participants With Pain by Location
Time frame: 24 hours
Ambulation Distance
Time frame: Post-op Day 1
Bartels Index
Time frame: Post-op Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29721648Sankineani SR, Reddy ARC, Eachempati KK, Jangale A, Gurava Reddy AV. Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Eur J Orthop Surg Traumatol. 2018 Oct;28(7):1391-1395. doi: 10.1007/s00590-018-2218-7. Epub 2018 May 2.
- Derived from this study: PubMed 35944566Bh PP, Jinadu S, Okunlola O, Darkzali H, Lin HM, Lai YH. Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. J Knee Surg. 2023 Oct;36(12):1289-1296. doi: 10.1055/s-0042-1755355. Epub 2022 Aug 9.
- Individual participant dataSharing planned: No
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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.
Yan H Lai, MD,MPH principal investigator
Ichan School of Medicine
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 Ipack, Bupivacaine and Peri Articular Infiltration in people with Osteo Arthritis Knee, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 9 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 3 Nov 2020. 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. 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 3 Nov 2020). 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?
Narcotic Consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03653416, which also lists 2 linked publications.
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 3 Nov 2020.