AnalgesiaPhase 4NCT06952556
Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following HTO/DFO/TTO
A Phase 4 study testing ACB and IPACK block in people with Analgesia, 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 high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesia
- What is being tested?
- ACB and IPACK block
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2025to 28 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 HTO/DFO/TTO.
- American Society of Anesthesiologists (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 ACLR.
- 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;
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- 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: 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 HTO/DFO/TTO
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 high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).
- Conditions
- Analgesia
- Being tested
- ACB, IPACK block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACBDrug
15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal.
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 |
|---|---|---|
| Adductor Canal Block (ACB) + IPACK Block | Experimental | Participants receive ACB with IPACK block. Receives: Drug: ACB; Drug: IPACK block |
| Isolated Adductor Canal Block | Active comparator | Participants receive ACB only. Receives: Drug: ACB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Utilization for First 24 Hours Post-Surgery
Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oral morphine equivalent.
Measured: Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])
Secondary outcomes (14)
Length of Stay in PACU
Length of time the patient is in the PACU prior to discharge.
Measured: Post-Operation (POD 0 - typically up to 3 hours)
Patient-Reported Visual Analogue Scale (VAS) Score - Baseline
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
Measured: Baseline
Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU)
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
Measured: Post-Operation (POD 0 - typically up to 3 hours)
Patient-Reported VAS Score - Post-Operative Day 1 (POD 1)
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
Measured: POD 1
Patient-Reported VAS Score - Post-Operative Day 2 (POD 2)
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
Measured: POD 2
Patient-Reported VAS Score - Post-Operative Day 3 (POD 3)
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
Measured: POD 3
Patient-Reported VAS Score - Post-Operative Day 7 (POD 7)
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
Measured: POD 7
Patient-Reported VAS Score - Month 6 Follow-Up
Patients rate their pain score on a scale from 0 to 10 (0 being no pain and 10 being the worst imaginable pain); the total score is the response.
Measured: Month 6 Post-Operation
Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline
7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function.
Measured: Baseline
KOOS-PS Score - Month 6 Follow-Up
7-item assessment of how well participants are able to perform different activities. Each item is rated on a 5-point Likert scale (0 to 4), with 0 representing "none" and 4 representing "extreme". The raw score is the sum of responses and is converted to a total score ranging from 0-100, where higher scores indicate greater function.
Measured: Month 6 Post-Operation
Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline
13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability.
Measured: Baseline
Kujala Score / AKPS - Month 6 Follow-Up
13-item self-report questionnaire that assesses subjective reactions to particular activities and symptoms that are known to correlate with anterior knee pain syndrome. The total score is the sum of responses and ranges from 0 to 100, with 100 being the highest possible score. Lower scores reflect greater pain and disability.
Measured: Month 6 Post-Operation
Tegner Activity Scale (TAS) Score - Baseline
The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response.
Measured: Baseline
Tegner Activity Scale (TAS) Score - Month 6 Follow-Up
The Tegner Activity Scale (TAS) is a 1-item, self-administered questionnaire used to assess a patient's ability to engage in work and sports activities. The item is rated on a scale of 0 to 10, with 0 representing maximum disability and 10 representing elite sports participation. The total score is the item response.
Measured: Month 6 Post-Operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start28 Apr 2025
- Primary completion28 Apr 2027 (estimated)
- Study completion28 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laith Jazrawi, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952556
- Sponsor's protocol ID
- 24-01855
- Status last verified
- Feb 2026
- First submitted
- 21 Apr 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The Investigators will not be sharing this information with other researchers beyond publishing our findings in a scientific journal.
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 HTO/DFO/TTO
- ClinicalTrials.gov ID
- NCT06952556
- Acronym / sponsor ID
- 24-01855
- Conditions
- Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- 28 Apr 2027 (estimated)
- Study completion
- 28 Jun 2027 (estimated)
- First posted
- 1 May 2025 (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.
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 high tibial osteotomy (HTO)/distal femoral osteotomy (DFO)/tibial tubercle osteotomy (TTO).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block (ACB) + IPACK Block | Experimental | Drug: ACB, Drug: IPACK blockParticipants receive ACB with IPACK block. |
| Isolated Adductor Canal Block | Active comparator | Drug: ACBParticipants receive ACB only. |
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 HTO/DFO/TTO.
- American Society of Anesthesiologists (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 ACLR.
- 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 |
|---|---|---|
| ACB15 mL of 0.25% Bupivacaine block of the saphenous nerve injected under ultrasound guidance via adductor canal. | Drug | Adductor Canal Block (ACB) + IPACK Block, Isolated Adductor Canal Block |
| IPACK blockIPACK block with 20 mL of 0.25% Bupivacaine injected into the Interspace between the Popliteal Artery and Capsule of the Knee | Drug | Adductor Canal Block (ACB) + IPACK Block |
Primary outcome
Opioid Utilization for First 24 Hours Post-Surgery
Time frame: Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])
Opioid utilization for the first 24 hours after surgery, including during surgery, calculated as oral morphine equivalent.
14 secondary outcomes
Length of Stay in PACU
Time frame: Post-Operation (POD 0 - typically up to 3 hours)
Patient-Reported Visual Analogue Scale (VAS) Score - Baseline
Time frame: Baseline
Patient-Reported VAS Score in Post-Anesthesia Care Unit (PACU)
Time frame: Post-Operation (POD 0 - typically up to 3 hours)
Patient-Reported VAS Score - Post-Operative Day 1 (POD 1)
Time frame: POD 1
Patient-Reported VAS Score - Post-Operative Day 2 (POD 2)
Time frame: POD 2
Patient-Reported VAS Score - Post-Operative Day 3 (POD 3)
Time frame: POD 3
Patient-Reported VAS Score - Post-Operative Day 7 (POD 7)
Time frame: POD 7
Patient-Reported VAS Score - Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Knee injury and Osteoarthritis Outcome Score (KOOS) - Physical Function Shortform (KOOS-PS) Score - Baseline
Time frame: Baseline
KOOS-PS Score - Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Kujala Score / Anterior Knee Pain Scale (AKPS) - Baseline
Time frame: Baseline
Kujala Score / AKPS - Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Tegner Activity Scale (TAS) Score - Baseline
Time frame: Baseline
Tegner Activity Scale (TAS) Score - Month 6 Follow-Up
Time frame: Month 6 Post-Operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No. The Investigators will not be sharing this information with other researchers beyond publishing our findings in a scientific journal.
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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.
Laith Jazrawi, 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 ACB and IPACK block in people with Analgesia, 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: looking for participants now, as of the sponsor's last update on 25 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laith Jazrawi, MD (646-501-7223, Laith.jazrawi@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Utilization for First 24 Hours Post-Surgery (time frame: Up to Hour 24 Post-Procedure (Post-Operative Day 1 [POD 1])). 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 25 Feb 2026.