ACB + IPACK Block for Pain Relief

Overseen By Laith Jazrawi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must not be taking: Opioids, Oxycodone

Disqualifiers: Chronic pain, Cognitive dysfunction, Neurologic disorder, Drug abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding an IPACK block (a type of pain relief shot) to an adductor canal block (another pain relief shot) reduces pain and the need for opioids after certain knee surgeries. The goal is to determine which combination of pain relief works better for individuals undergoing high tibial osteotomy, distal femoral osteotomy, or tibial tubercle osteotomy. It suits patients scheduled for these surgeries who do not have long-term pain issues or other specific health problems. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What is the safety track record for these treatments?

Research has shown that the adductor canal block (ACB) combined with the IPACK block is generally well-tolerated by patients undergoing knee surgery. One study found that this combination provided better pain relief and reduced the need for opioids post-surgery, indicating its safety and effectiveness.

Another study found that using ACB with the IPACK block before surgery helped reduce the risk and severity of long-term pain three months after surgery. Importantly, the adductor canal block itself is recognized as a safe method for pain relief following knee operations.

Overall, evidence suggests these treatments effectively reduce pain with minimal side effects. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the ACB + IPACK Block treatment for pain relief because it offers a potentially more effective approach to managing postoperative pain, particularly after knee surgeries. Unlike standard treatments that often rely solely on an Adductor Canal Block (ACB), this approach combines ACB with an IPACK block, which targets additional nerves responsible for pain in the knee area. This combination aims to provide more comprehensive pain relief, potentially reducing the need for opioids and their associated side effects. By tackling pain from multiple angles, this method could enhance patient comfort and speed up recovery.

What evidence suggests that this trial's treatments could be effective for post-operative pain relief in osteotomy patients?

Research shows that using an Adductor Canal Block (ACB) with an IPACK block effectively relieves pain after knee surgery. In this trial, some participants will receive the combination of ACB and IPACK block, which studies have found reduces pain both at rest and during knee movement for up to 8 hours post-operation. Patients receiving ACB plus IPACK reported less long-term pain three months after surgery compared to those who received a placebo. Additionally, this approach can lower the need for opioids, which are strong painkillers with potential side effects. The evidence supporting ACB plus IPACK demonstrates a strong record in managing pain after knee surgeries. ^{2 6 7 8 9}

Who Is on the Research Team?

Laith Jazrawi, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for patients aged 18-75 undergoing high tibial, distal femoral, or tibial tubercle osteotomy with low risk of complications (ASA I or II). Excluded are those with chronic pain and opioid use, allergies to oxycodone, additional knee procedures, extreme obesity (BMI over 45), cognitive issues, substance abuse history, severe organ disease, inability to follow instructions or pregnant women.

Inclusion Criteria

I am undergoing leg realignment surgery.

I am in good or mild systemic disease condition.

Exclusion Criteria

I have been using opioids for chronic pain for over 3 months.

Patients who are allergic to oxycodone

I am having surgery on my cartilage or ACL.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an isolated adductor canal block or an adductor canal block combined with IPACK infiltration to manage post-operative pain

1 week

Daily visits during the first week post-operation

Follow-up

Participants are monitored for pain and opioid consumption, with assessments at various post-operative days and a 6-month follow-up

6 months

Multiple visits including POD 1, POD 2, POD 3, POD 7, and Month 6

What Are the Treatments Tested in This Trial?

Interventions

• Adductor Canal Block
• IPACK Block

Trial Overview

The study compares the effectiveness of two pain relief methods after leg bone surgery: one group receives an adductor canal block combined with IPACK infiltration while another gets only the adductor canal block. It's a randomized trial focusing on post-op pain and opioid use.

How Is the Trial Designed?

Group I: Adductor Canal Block (ACB) + IPACK Block Experimental Treatment 2 Interventions

Participants receive ACB with IPACK block.

Group II: Isolated Adductor Canal Block Active Control 1 Intervention

Participants receive ACB only.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a study of 30 patients undergoing total knee arthroplasty, both adductor canal block (ACB) and femoral nerve block (FNB) provided similar levels of pain relief, with no significant difference in morphine consumption in the first 24 hours post-surgery.

Both techniques also preserved quadriceps strength equally well, showing no significant differences in muscle strength or functional recovery at 24 and 48 hours after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial comparing adductor canal block and femoral nerve block for knee arthroplasty. Lim, YC., Quek, HYK., Phoo, WHJ., et al.[2020]

The combination of adductor canal block (ACB) with iPACK block provides noninferior pain relief compared to ACB with periarticular injection (PAI) after total knee arthroplasty, as shown in a study of 76 patients.

However, patients receiving the ACB + iPACK block required significantly more morphine and experienced greater reductions in quadriceps strength immediately after surgery, indicating potential trade-offs in functional performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adductor Canal Block Combined With iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block vs Periarticular Injection for Analgesia After Total Knee Arthroplasty: A Randomized Noninferiority Trial. Kertkiatkachorn, W., Kampitak, W., Tanavalee, A., et al.[2021]

In a study of 70 patients undergoing arthroscopic knee surgeries under spinal anesthesia, those who received an adductor canal block (ACB) experienced significantly lower morphine consumption (8.63 mg) compared to those who did not receive the block (21.91 mg), indicating ACB's effectiveness in pain management.

The ACB not only prolonged the duration of analgesia (approximately 366 minutes vs. 150 minutes) but also resulted in lower pain scores during rest and knee flexion, while maintaining better hemodynamic stability and showing no complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Analgesic Efficacy of Ultrasound-Guided Adductor Canal Block With 20 mL of 0.5% Ropivacaine in Patients Undergoing Knee Surgeries-A Randomized Control Trial. Arumugam, P., Ravi, S., Ln, S., et al.[2023]

In a study of 120 patients undergoing total knee arthroplasty, the combination of adductor canal block (ACB) and interspace between popliteal artery and capsule of posterior knee block (IPACK) provided significantly better pain relief compared to ACB alone, as measured by VAS scores.

Patients receiving the ACB+IPACK technique also demonstrated improved range of motion and ambulation distance post-surgery, indicating that this method enhances recovery without compromising motor function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of adductor canal block and IPACK block (interspace between the popliteal artery and the capsule of the posterior knee) with adductor canal block alone after total knee arthroplasty: a prospective control trial on pain and knee function in immediate postoperative period. Sankineani, SR., Reddy, ARC., Eachempati, KK., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12083146/

Comparative analysis of adductor canal block combined ...

The A + I regimen demonstrated superior analgesic efficacy, reduced motor blockade, and earlier ambulation compared to S + F in TKA patients.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0883540321007907

Primary Knee Adductor Canal Block Combined With IPACK ...

Our results showed that an ACB + IPACK block can provide analgesia for postoperative pain at rest and with knee maximum flexion up to 8 hours.

3.

bmcanesthesiol.biomedcentral.com

bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-024-02707-2

Effect of adductor canal block combined with infiltration ...

ACB combined with IPACK before surgery decreases the incidence and intensity of chronic pain 3 months after TKA compared with placebo injection.

4.

eurarchmedres.org

eurarchmedres.org/article/EAMR-18199/pdf

Comparing the Effectiveness of Adductor Canal and ...

The primary outcome compares analgesic efficacy at different time points (1st, 8th, and 24th hours post-block administration) between the ACB + IPACK block ...

5.

tandfonline.com

tandfonline.com/doi/full/10.1080/11101849.2023.2238530

Postoperative analgesic effectiveness of ultrasound guided ...

Femoral-Sciatic group had lower opioid consumption. The Adductor-IPACK group showed a statistically significant higher Modified Bromage score.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11748369/

Adductor Canal Block Combined With IPACK Block for ...

This retrospective study found associations between combined ACB and IPACK block and better pain relief, reduced opioid use, improved postoperative motor ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S277260962500005X

Review Article Adductor canal block in total knee arthroplasty

Adductor canal block is a safe and potentially effective peripheral nerve block for reducing postoperative pain after total knee arthroplasty while preserving ...

8.

journals.lww.com

journals.lww.com/md-journal/fulltext/2021/06040/analgesia_effects_of_ipack_block_added_to.13.aspx

Analgesia effects of IPACK block added to multimodal...

The most important finding in our study was that although IPACK block supplementation improved pain scores at 12 hours with rest or activity after surgery, no ...

9.

rapm.bmj.com

rapm.bmj.com/content/48/2/49

a systemic review and meta-analysis of randomized trials

Conclusions Our results suggest that continuous catheter-based ACB does not enhance or prolong the analgesic benefits when compared with single-shot ACB for TKA ...