Anterior Cruciate Ligament RupturePhase 4NCT05286307
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft:
A Phase 4 study testing IPACK block in people with Anterior Cruciate Ligament Rupture, run by NYU Langone Health at 1 site in United States.
Trial summary
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- IPACK block
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to 18 Dec 2023
- 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
- Patients between 18 and 75 years of age
- Patients undergoing primary ACL reconstruction with BPTB Autograft
- ASA I or II
Who cannot join
- Patients younger than 18 and older than 75.
- Patients with multi-ligament injury
- Patients undergoing concomitant cartilage procedure or osteotomy.
- Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
- Patients who are allergic to oxycodone;
- Patients with diagnosed or self-reported cognitive dysfunction;
Show all 14Show fewer
- Patients with a history of neurologic disorder that can interfere with pain sensation;
- Patients with a history of drug or recorded alcohol abuse;
- Patients who are unable to understand or follow instructions;
- Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
- Patients with a BMI over 45;
- Any patient that the investigators feel cannot comply with all study related procedures;
- Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft: A Single Center Randomized Placebo-Controlled Trial
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft
Read the detailed description
The protocol will determine if the addition of an IPACK block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing ACLR with Bone Patellar Tendon Bone Autograft
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- IPACK block
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACK blockDrug
IPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving IPACK block | Experimental | Patients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. Receives: Drug: IPACK block |
| Standard of care group | No intervention | Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Utilization in First 24 Hours Post-Surgery
Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.
Measured: Up to Hour 24 Post-Operation
Secondary outcomes (9)
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score ranges from 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Hour 24 Post-Operation
Patient-Reported VAS Scores at 48 Hours Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Hour 48 Post-Operation
Patient-Reported VAS Scores at 72 Hours Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Hour 72 Post-Operation
Patient-Reported VAS Scores at Day 7 Post-Surgery
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 100 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Day 7 Post-Operation
Length of Stay in Post-Anesthesia Care Unit (PACU)
Measured by the length of stay after surgery (minutes)
Measured: Up to Day 1 Post-Operation
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)
The KOOS-PS is a 7-item measure of physical functional derived from the items of the Function, daily living and Function, sports and recreational activity subscales of the KOOS. It is a 42-item questionnaire, including 5 subscales: symptoms, pain, ADLs, sports/recreation, and quality of life. The raw score is calculated by summing the responses and ranges from 0-28. The raw score is converted to a true interval score ranging from 0-100, where higher scores indicate greater physical function.
Measured: Baseline, Month 6 Post-Operation Visit
Change in Kujala Scale Score
Knee pain will be measured by self reported Kujala scale. The Kujala Scale is a 13-item screening instrument designed to assess patellofemoral pain in adolescents and young adults, with a variable ordinal response format. For example, a 'Limp' score would be scored as follows: none (5), slight/periodic (3), constant (0). The total score ranges from 0 to 100; higher scores indicate lesser knee pain.
Measured: Baseline, Month 6 Post-Operation Visit
Change in Tegner Activity Scale (TAS) Score
The TAS asks participants to indicate the highest level of activity they are able to participate in at the time of the survey. The options range from Level 10 (competitive sports on a national elite level) to Level 0 (sick leave or disability pension because of knee problems). The total score corresponds with the selected Level and ranges from 0-10; higher scores indicate higher levels of activity.
Measured: Baseline, Month 6 Post-Operation Visit
Change of Range of Motion (ROM) Assessment
A Range of Motion (ROM) assessment is most commonly used to measure movement of the ankles, knees, hips, shoulders, elbows, wrists and fingers. Measures of knee ROM will be taken at baseline and Month 6 to assess the change in ROM over time.
Measured: Baseline, Month 6 Post-Operation Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start11 Jul 2022
- Primary completion31 Mar 2023
- Study completion18 Dec 2023
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 (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric J Strauss, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05286307
- Sponsor's protocol ID
- 22-00148
- Status last verified
- Apr 2024
- First submitted
- 10 Mar 2022
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data will be maintained in an encrypted REDCap database to be accessed only by the principal investigator and study team members
Publications
Rao N, Triana J, Avila A, Campbell KA, Alaia MJ, Jazrawi LM, Furiguele D, Popovic J, Strauss EJ. Postoperative Pain and Opioid Usage With Combined Adductor Canal and IPACK Block Versus Isolated Adductor Canal Block After Anterior Cruciate Ligament Reconstruction With a Bone-Patellar Tendon-Bone Autograft: A Single-Center Randomized Controlled Trial. Am J Sports Med. 2025 May;53(6):1359-1367. doi: 10.1177/03635465251328609. Epub 2025 May 1.
PubMed 40308075
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft: A Single Center Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT05286307
- Acronym / sponsor ID
- 22-00148
- Conditions
- Anterior Cruciate Ligament Rupture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Posted 26 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft
Detailed description
The protocol will determine if the addition of an IPACK block to the standard adductor canal block is superior to an isolated adductor canal block in controlling post-operative pain and decreasing postoperative opioid consumption in patients undergoing ACLR with Bone Patellar Tendon Bone Autograft
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving IPACK block | Experimental | Drug: IPACK blockPatients in this study group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). And receive the additional IPACK block performed using 20 mL of Bupivacaine (0.25%) injected into the interspace between the popliteal artery and capsule of the knee. |
| Standard of care group | No intervention | –Patients in the control group will receive the standard of care adductor canal block composed of 15 mL of Bupivacaine (0.25%). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients between 18 and 75 years of age
- Patients undergoing primary ACL reconstruction with BPTB Autograft
- ASA I or II
Key exclusion criteria (14 listed)
- Patients younger than 18 and older than 75.
- Patients with multi-ligament injury
- Patients undergoing concomitant cartilage procedure or osteotomy.
- Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer.
- Patients who are allergic to oxycodone;
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 |
|---|---|---|
| IPACK blockIPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | Drug | Participants receiving IPACK block |
Primary outcome
Opioid Utilization in First 24 Hours Post-Surgery
Time frame: Up to Hour 24 Post-Operation
Opioid utilization for the first 24 hours after surgery, including during surgery, is calculated as oral morphine equivalent.
9 secondary outcomes
Patient-Reported Visual Analog Scale (VAS) Scores at 24 Hours Post-Surgery
Time frame: Hour 24 Post-Operation
Patient-Reported VAS Scores at 48 Hours Post-Surgery
Time frame: Hour 48 Post-Operation
Patient-Reported VAS Scores at 72 Hours Post-Surgery
Time frame: Hour 72 Post-Operation
Patient-Reported VAS Scores at Day 7 Post-Surgery
Time frame: Day 7 Post-Operation
Length of Stay in Post-Anesthesia Care Unit (PACU)
Time frame: Up to Day 1 Post-Operation
Change in Knee Injury and Osteoarthritis Outcome Score- Physical Function Short Form (KOOS-PS)
Time frame: Baseline, Month 6 Post-Operation Visit
Change in Kujala Scale Score
Time frame: Baseline, Month 6 Post-Operation Visit
Change in Tegner Activity Scale (TAS) Score
Time frame: Baseline, Month 6 Post-Operation Visit
Change of Range of Motion (ROM) Assessment
Time frame: Baseline, Month 6 Post-Operation Visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40308075Rao N, Triana J, Avila A, Campbell KA, Alaia MJ, Jazrawi LM, Furiguele D, Popovic J, Strauss EJ. Postoperative Pain and Opioid Usage With Combined Adductor Canal and IPACK Block Versus Isolated Adductor Canal Block After Anterior Cruciate Ligament Reconstruction With a Bone-Patellar Tendon-Bone Autograft: A Single-Center Randomized Controlled Trial. Am J Sports Med. 2025 May;53(6):1359-1367. doi: 10.1177/03635465251328609. Epub 2025 May 1.
- Individual participant dataSharing planned: No. Participant data will be maintained in an encrypted REDCap database to be accessed only by the principal investigator and study team members
Related trials for Anterior Cruciate Ligament Rupture
Not yet recruiting
Supporting Athletes' Return to Sports After ACL Reconstruction: A Study of a Psychological Readiness Program
Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
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.
Eric J Strauss, MD principal investigator
NYU Langone Health
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 block in people with Anterior Cruciate Ligament Rupture, run by NYU Langone Health 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 26 Apr 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 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 26 Apr 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?
Opioid Utilization in First 24 Hours Post-Surgery (time frame: Up to Hour 24 Post-Operation). 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 NCT05286307, which also lists 1 linked publication.
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 26 Apr 2024.