Knee Arthroplasty, TotalPhase 3NCT03703206
The Analgesic Efficacy of Protocol for Primary Total Knee Arthroplasty (TKA)
A Phase 3 study testing ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK) in people with Knee Arthroplasty, Total, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 27 Aug 2021
- Phase
- Phase 3
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for total knee arthroplasty
- American Society Anesthesiologists (ASA) physical status I- III.
- Mentally competent and able to give consent for enrollment in the study.
Who cannot join
- Patient refusal,
- allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
- Revision surgery will be excluded.
- Impaired kidney functions
- patient with coagulopathy will be also excluded.
- Chronic pain syndromes and patients with chronic opioid use in excess of a daily morphine equivalent dose (MED) of 40mg or greater for the past 3 months prior to the surgery.
- BMI of 45 or more
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty
This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).
- Conditions
- Knee Arthroplasty, Total
- Being tested
- ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)Drug
Also called iPACK
nerve block for posterior knee pain after a TKA.
| Study group | Role | What they receive |
|---|---|---|
| ACB + iPACK | Experimental | Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). Receives: Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK) |
| ACB w/o iPACK | No intervention | Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery
Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator
Measured: Six hours after surgery
Secondary outcomes (2)
Pain Score Measurement Reported by Patients
Average of pain scores over the first 24 hours following the regional anesthetic based on Numeric Rating Scale ( NRS). The scale is from 0 - 10, where 0 is no pain and 10 is the worst pain possible.
Measured: 24 hours after surgery
Quality of Recovery (QoR) Score
Score of QoR-15 survey to determine recovery status. The questionnaire is a 15 item questionnaire and each question has a score possible from 0-10. It has two parts. Part 1 includes questions from 1-10. the scale on this question ranges from 0=none of the time ( poor) to 10=all the time ( excellent). The 2nd part include questions from 11-15 where the scale goes from 10 to 0, where 10=none of the time ( excellent) and 0=all the time (poor). The total score is obtained by adding the scores of all the 15 questions. The total score is 0 (poor_ to 150 (excellent).
Measured: one week, measurements are obtained at 24 hours, 48 hours, and one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Jul 2018
- Primary completion27 Aug 2019
- Study completion27 Aug 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 Arthroplasty, TotalStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Taras Grosh, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03703206
- Sponsor's protocol ID
- 828618
- Status last verified
- May 2024
- First submitted
- 27 Jul 2018
- Last updated
- 30 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Adding the IPACK Block to a Multimodal Analgesia Protocol for Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03703206
- Acronym / sponsor ID
- 828618
- Conditions
- Knee Arthroplasty, Total
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 11 Oct 2018 (actual)
- Results
- Posted 30 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a perspective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups to assess the analgesic efficacy of adding the iPACK (injection between the popliteal artery and the capsule of the knee) in addition to the adductor canal block (ACB) for Total Knee Arthoplasty patients (TKA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, blinded study with a parallel design and an allocation ratio of 1 to 1 for the treatment groups
| Arm | Type | Receives |
|---|---|---|
| ACB + iPACK | Experimental | Drug: ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)Patients scheduled for TKA will be randomized to receive an adductor canal block with an additional ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK). |
| ACB w/o iPACK | No intervention | –Patients enrolled in this arm will receive the standard of care adductor canal block (ACB) prior to their total knee arthoplasty. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for total knee arthroplasty
- American Society Anesthesiologists (ASA) physical status I- III.
- Mentally competent and able to give consent for enrollment in the study.
Key exclusion criteria (7 listed)
- Patient refusal,
- allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol (MP3).
- Revision surgery will be excluded.
- Impaired kidney functions
- patient with coagulopathy will be also excluded.
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 |
|---|---|---|
| ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)Also: iPACKnerve block for posterior knee pain after a TKA. | Drug | ACB + iPACK |
Primary outcome
Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery
Time frame: Six hours after surgery
Each patient will be provided by a colored chart that will have different parts of the knee marked clearly and they will indicate whether the pain they have in which region of the knee. the different regions are ( anterior, posterior, lateral, medial, and the middle of the thigh). it will be marked as a yes or no question. it will be measured as a ratio of patients in each patient who has the pain in the numerator and all patients in the study will be in the denominator
2 secondary outcomes
Pain Score Measurement Reported by Patients
Time frame: 24 hours after surgery
Quality of Recovery (QoR) Score
Time frame: one week, measurements are obtained at 24 hours, 48 hours, and one week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Taras Grosh, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK) in people with Knee Arthroplasty, Total, run by University of Pennsylvania 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 7 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 30 May 2024. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 30 May 2024). 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?
Percentage of Patients Presenting With Pain in the Back of the Knee 6 Hours After Surgery (time frame: Six hours after surgery). 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 30 May 2024.