Adductor canal plus IPACK block versus adductor canal block alone for pain control after 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 HTO/DFO/TTO
This study tests whether adding an IPACK block to an adductor canal block reduces postoperative pain and opioid use in adults having high tibial, distal femoral, or tibial tubercle osteotomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06952556 on ClinicalTrials.gov |
What this trial studies
This randomized, single-blind, single-center Phase 4 trial compares combined adductor canal block (ACB) plus IPACK infiltration to isolated ACB in adults undergoing high tibial osteotomy (HTO), distal femoral osteotomy (DFO), or tibial tubercle osteotomy (TTO). Participants aged 18–75 with ASA I–II are randomized to receive either ACB+IPACK or ACB alone, with patients blinded to allocation. The primary outcomes are postoperative pain scores and opioid consumption monitored in the immediate postoperative period and during early follow-up. Key exclusions include chronic opioid use, multi-ligament injuries, concomitant cartilage procedures or ACL reconstruction, significant organ disease, and neurologic or cognitive conditions that affect pain reporting.
Who should consider this trial
Good fit: Adults 18–75 years old with ASA I–II who are scheduled for HTO, DFO, or TTO and who are not chronic opioid users or severely ill are the ideal candidates.
Not a fit: Patients with multi‑ligament injuries, those having concomitant cartilage procedures or ACL reconstruction, chronic opioid users, people with significant cardiac, hepatic, or renal disease, neurologic disorders affecting pain perception, or allergies to study medications may not benefit or be eligible.
Why it matters
Potential benefit: If successful, adding the IPACK block could reduce pain and opioid requirements after these knee osteotomy procedures, potentially speeding recovery and lowering opioid-related side effects.
How similar studies have performed: Combined ACB and IPACK approaches have reduced posterior knee pain and opioid consumption in total knee arthroplasty studies, but evidence specific to osteotomy procedures is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients between 18 and 75 years of age * Patients undergoing HTO/DFO/TTO. * American Society of Anesthesiologists (ASA) I or II Exclusion Criteria: * 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; * 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;
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Laith Jazrawi, MD — NYU Langone Health
- Study coordinator: Laith Jazrawi, MD
- Email: Laith.jazrawi@nyulangone.org
- Phone: 646-501-7223
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.