Pain, PostoperativePhase 3NCT05316168
Post Operative Pain Management for ACL Reconstruction
A Phase 3 study testing Bupivacaine HCl 0.5% Injectable Solution, Dexamethasone and Infiltration between Popliteal Artery and Capsule of the knee (iPACK) in people with Pain, Postoperative, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine HCl 0.5% Injectable Solution, Dexamethasone and Infiltration between Popliteal Artery and Capsule of the knee (iPACK)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2023to 30 Sep 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.
Who cannot join
- Revision ACLR, worker's compensation, pregnancy, age<18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial
Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK.
The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine HCl 0.5% Injectable Solution, Dexamethasone, Infiltration between Popliteal Artery and Capsule of the knee (iPACK), Percocet 5Mg-325Mg Tablet
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine HCl 0.5% Injectable SolutionDrug
During adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5%
DexamethasoneDrug
During adductor canal block participants will receive 2mg Dexamethasone
Infiltration between Popliteal Artery and Capsule of the knee (iPACK)Procedure or surgery
Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone
Percocet 5Mg-325Mg TabletDrug
Participant will receive 20 Percocet 5/325mg tablets post surgery for pain control
| Study group | Role | What they receive |
|---|---|---|
| isolated adductor canal block (ACB) | Active comparator | Adductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone. Receives: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Dexamethasone; Drug: Percocet 5Mg-325Mg Tablet |
| isolated adductor canal block (ACB) + IPACK | Active comparator | ACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone. Receives: Drug: Bupivacaine HCl 0.5% Injectable Solution; Drug: Dexamethasone; Procedure: Infiltration between Popliteal Artery and Capsule of the knee (iPACK); Drug: Percocet 5Mg-325Mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain management
This will be measured by the participants completing a pain and medication Use questionnaire
Measured: 14 days
Post operative pain management 2
Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start30 Sep 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05316168
- Sponsor's protocol ID
- ftjo21D.1099
- Status last verified
- Sep 2023
- First submitted
- 2 Dec 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Isolated Adductor Canal Block vs Adductor Canal Block With IPACK in ACL Reconstruction: A Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT05316168
- Acronym / sponsor ID
- ftjo21D.1099
- Conditions
- Pain, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Health care providers are seeking methods to limit post-operative pain and opioid prescriptions to reduce the burden of the national opioid use epidemic. Adductor canal block (ACB) is a peripheral nerve block that has been shown to reduce pain and opioid usage with minimal effect on quadriceps function in patients undergoing arthroscopic knee surgery. Infiltration between Popliteal Artery and Capsule of the Knee (iPACK) block has also shown promise in reducing pain and opioid usage, specifically reducing posterior knee pain, which ACB is not able to achieve. To our knowledge, there is currently no study in the orthopedic literature comparing post-operative pain and opioid consumption in ACL reconstruction (ACLR) patients who received isolated ACB versus ACB with IPACK.
The primary aim of this study is to investigate the role of IPACK in combination with ACB in reducing peri-operative (14-days) pain levels in ACLR patients. The secondary aim is to determine the effectiveness of IPACK in reducing post-operative opioid use. The tertiary aim is to determine any effect of IPACK on post-operative functional outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isolated adductor canal block (ACB) | Active comparator | Drug: Bupivacaine HCl 0.5% Injectable Solution, Drug: Dexamethasone, Drug: Percocet 5Mg-325Mg TabletAdductor Canal Block with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone. |
| isolated adductor canal block (ACB) + IPACK | Active comparator | Drug: Bupivacaine HCl 0.5% Injectable Solution, Drug: Dexamethasone, Procedure: Infiltration between Popliteal Artery and Capsule of the knee (iPACK), Drug: Percocet 5Mg-325Mg TabletACB with 20cc 0.5% bupivacaine HCl + 2mg dexamethasone, and iPACK with 20cc 0.5% bupivacaine + 2mg dexamethasone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing primary ACLR for ACL tear, including patients with concomitant meniscectomy or meniscal repair.
Key exclusion criteria (1 listed)
- Revision ACLR, worker's compensation, pregnancy, age<18 years
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 |
|---|---|---|
| Bupivacaine HCl 0.5% Injectable SolutionDuring adductor canal block participants will receive 20cc of Bupivacaine HCl 0.5% | Drug | isolated adductor canal block (ACB), isolated adductor canal block (ACB) + IPACK |
| DexamethasoneDuring adductor canal block participants will receive 2mg Dexamethasone | Drug | isolated adductor canal block (ACB), isolated adductor canal block (ACB) + IPACK |
| Infiltration between Popliteal Artery and Capsule of the knee (iPACK)Prior to closing the surgical wound participants will receive a local injections of 20cc 0.5% bupivacaine mixed with 2mg dexamethasone | Procedure or surgery | isolated adductor canal block (ACB) + IPACK |
| Percocet 5Mg-325Mg TabletParticipant will receive 20 Percocet 5/325mg tablets post surgery for pain control | Drug | isolated adductor canal block (ACB), isolated adductor canal block (ACB) + IPACK |
Primary outcome
Post operative pain management
Time frame: 14 days
This will be measured by the participants completing a pain and medication Use questionnaire
Post operative pain management 2
Time frame: 6 months
Participants will also complete the International Knee Documentation Committee (IKDC) questionnaires
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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 3 study testing Bupivacaine HCl 0.5% Injectable Solution, Dexamethasone and Infiltration between Popliteal Artery and Capsule of the knee (iPACK) in people with Pain, Postoperative, run by Rothman Institute Orthopaedics 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?
Results are not available in the source record.
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?
Post operative pain management (time frame: 14 days). The study lists 2 primary outcomes in all. 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 Sep 2023.