IPACK Block for Postoperative Pain After ACL Surgery

Overseen By John Miller, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: Loyola University

Must not be taking: Opioids

Disqualifiers: Previous knee surgery, Chronic opioid use, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

78 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to learn whether using an anesthetic technique called IPACK block will control pain after ACL reconstruction surgery. The main questions it aims to answer are: * if participants who receive the IPACK block prior to ACL reconstruction experience less pain after surgery and at 1 day after surgery * if participants who receive the IPACK block prior to ACL reconstruction require less short-term opioid use immediately after surgery and up to one week after surgery. Participants will be randomized 1:1 to 1 of 2 groups: Use of IPACK block during ACL reconstruction vs. placebo (a placebo is a look-alike substance that contains no active drug). Neither the participant nor the investigator will know which group the participants has been assigned to. Researchers will compare self-reported pain scores and short-term opioid use of all study participants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are a chronic opioid user, you cannot participate in the trial.

What data supports the effectiveness of the IPACK treatment for reducing postoperative pain after ACL surgery?

Research on the IPACK treatment for knee surgeries, like total knee replacement, shows it may help reduce pain in the back of the knee. One study found that patients who received the IPACK treatment had less posterior knee pain compared to those who did not. ^{1 2 3 4 5}

Is the IPACK block safe for use in humans?

The IPACK block, used to manage knee pain, has been studied in various settings, including total knee arthroplasty, and no significant safety concerns have been reported in the available research. ^{1 3 4 6 7}

How does the IPACK block treatment differ from other treatments for postoperative pain after ACL surgery?

The IPACK block is a novel technique that targets pain in the back of the knee by injecting anesthetic between the popliteal artery and the knee capsule, providing effective pain relief without causing muscle weakness. This approach is unique because it can reduce the need for opioids and enhance the effects of other nerve blocks used in knee surgeries. ^{1 4 8 9 10}

Eligibility Criteria

This trial is for patients 16 or older who are undergoing ACL reconstruction at Loyola University Medical Center and can make their own medical decisions. It's not for those with chronic opioid use, using cadaver grafts, allergic to local anesthetics, or with past surgery/infections in the knee.

Inclusion Criteria

I am 16 years old or older.

I can make my own medical decisions and agree to join the study.

I am choosing to have ACL surgery with Dr. John Miller at Loyola University.

Exclusion Criteria

I am using a cadaver's tissue for my ACL surgery.

I have had a knee infection before.

I have had surgery on my knee before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo ACL reconstruction surgery with either an IPACK block or placebo

1 day

1 visit (in-person)

Immediate Post-operative Monitoring

Pain scores and opioid consumption are monitored in the PACU immediately after surgery

2-3 hours

1 visit (in-person)

Follow-up

Participants are monitored for pain scores and opioid use up to one week post-operatively

1 week

1 visit (in-person or phone call)

Treatment Details

Interventions

• IPACK
• PLACEBO

Trial Overview The study tests if the IPACK block—anesthetic technique—reduces pain and opioid use after ACL surgery compared to a placebo. Participants are randomly assigned to either receive IPACK or a placebo without knowing which one they get.

Participant Groups

Group I: IPACK Experimental Treatment 1 Intervention

After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of 0.5% bupivacaine will be injected.

Group II: Placebo Placebo Group 1 Intervention

After the adductor canal block, the anesthesiologist will reposition, visualize the anatomy of the IPACK block with ultrasound, and place 1% lidocaine for skin infiltration. Once adequate needle visualization is achieved within the correct anatomic position and plane, 20mL of normal saline will be injected.

Who Is Running the Clinical Trial?

Loyola University

Lead Sponsor

Trials

161

Recruited

31,400+

Findings from Research

The implementation of the IPACK block in total knee arthroplasty patients significantly reduced the lowest pain scores on postoperative day 0 compared to patients who did not receive the block, indicating its efficacy in pain management.

Despite the improvement in pain scores, other outcomes such as opioid consumption, ambulation distance, and length of stay remained unchanged, suggesting that while IPACK blocks can enhance early pain relief, they do not affect overall recovery metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block into a multimodal analgesic pathway for total knee replacement. Kandarian, B., Indelli, PF., Sinha, S., et al.[2020]

The iPACK block significantly reduced postoperative pain scores during activity at 4 hours after total knee arthroplasty compared to periarticular local infiltration analgesia (LIA), indicating its effectiveness for immediate pain control.

Patients receiving the iPACK block demonstrated faster physical rehabilitation, as shown by quicker performance in the timed up and go test, while both techniques did not differ in knee range of motion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of interspace between the popliteal artery and the capsule of the posterior knee (iPACK) block versus periarticular local infiltration analgesia after unilateral total knee arthroplasty: Prospective randomized control trial. Narejo, AS., Abdulwahab, F., Aqil, M., et al.[2022]

In a study of 96 patients undergoing total knee arthroplasty (TKA), adding an interspace between the popliteal artery and capsule of the posterior knee (IPACK) block to an enhanced recovery after surgery (ERAS) pathway did not significantly reduce opioid consumption or improve most functional outcomes.

However, the IPACK block was associated with a significantly lower incidence of posterior knee pain (8.7% in the IPACK group vs. 39% in the control group), suggesting it may help alleviate this specific type of pain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. Bh, PP., Jinadu, S., Okunlola, O., et al.[2023]

The iPACK block is an effective method for managing chronic knee joint pain in patients with knee osteoarthritis, demonstrating its potential for pain control.

This technique may also be beneficial in perioperative settings and for other pain-related procedures, such as radiofrequency ablation, by targeting the popliteal plexus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the iPACK block to reduce chronic pain in a patient with knee osteoarthritis: A case report. Kim, J., Lee, K., Kim, Y., et al.[2021]

In a cadaveric study involving 14 specimens, both proximal and distal ultrasound-guided iPACK injection techniques achieved similar areas of dye spread in the popliteal region, indicating effective targeting of posterior knee pain after total knee arthroplasty.

The proximal injection technique resulted in greater anteromedial dye spread, while the distal technique showed more anterolateral spread, suggesting that the choice of injection technique can influence the distribution of analgesic effects in the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the iPACK block injectate spread: a cadaveric study. Tran, J., Giron Arango, L., Peng, P., et al.[2019]

In a study of 89 patients undergoing unilateral primary total knee arthroplasty, the addition of the IPACK block to standard adductor canal block (ACB) and periarticular injection (PAI) did not significantly reduce postoperative pain compared to ACB and PAI alone.

There were no differences in opioid usage or ambulation pain between the two groups, suggesting that the IPACK block may not provide additional benefits for pain management in this surgical context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of adding an interspace block to the posterior knee for perioperative pain in total knee arthroplasty: a randomized controlled trial. Chatmaitri, S., Tangwiwat, S., Halilamien, P., et al.[2022]

The combination of iPACK block and adductor canal block (ACB) significantly reduced opioid consumption in the first 24 hours after total knee arthroplasty (TKA), suggesting a more effective pain management strategy.

While the iPACK block + ACB group showed lower Visual Analogue Scale (VAS) scores for pain at rest and during activity on the day of surgery, these differences did not reach the minimal clinically important difference, indicating that while beneficial, the combination may not lead to substantial improvements in pain perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Addition of iPACK Block to Adductor Canal Block Provide Improved Analgesic Effect in Total Knee Arthroplasty? A Systematic Review and Meta-Analysis. Wang, JH., Ma, HH., Chou, TA., et al.[2023]

The infiltration between the popliteal artery and capsule of the knee (IPACK) block significantly enhances postoperative pain control for knee surgery, reducing the need for opioid painkillers.

This study presents a straightforward and reproducible technique for administering the IPACK block during arthroscopic procedures, improving patient comfort and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgeon-Directed Arthroscopic Infiltration Between the Popliteal Artery and Capsule of the Knee (IPACK) Block: Technical Description. Shroff, JB., Hanna, P., Edgar, CM.[2023]

The IPACK block, which targets the area between the popliteal artery and the knee capsule, shows promise as an effective analgesic strategy for knee pain, particularly in surgeries like knee replacement and ACL reconstruction, based on a review of 35 studies.

When used in combination with the adductor canal block (ACB), the IPACK block may enhance pain relief and functional outcomes while reducing the risk of complications like foot drop compared to traditional tibial nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. Chan, E., Howle, R., Onwochei, D., et al.[2021]

The IPACK technique, used in three adolescent patients undergoing ACL surgery, effectively provided additional pain relief by targeting the area behind the knee, enhancing the effects of a continuous femoral nerve block.

This method resulted in minimal opioid requirements for pain management post-surgery and did not cause any motor weakness in the sciatic nerve, indicating a safe approach for pain control in adolescents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infiltration Between Popliteal Artery and Capsule of the Knee Block to Augment Continuous Femoral Nerve Catheter for Adolescent Anterior Cruciate Ligament Reconstruction: A Case Series. Nguyen, KT., Marcelino, R., Jagannathan, N., et al.[2021]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Implementation of the IPACK (Infiltration between the Popliteal Artery and Capsule of the Knee) block into a multimodal analgesic pathway for total knee replacement. [2020]

2. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Efficacy of interspace between the popliteal artery and the capsule of the posterior knee (iPACK) block versus periarticular local infiltration analgesia after unilateral total knee arthroplasty: Prospective randomized control trial. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Integrating IPACK (Interspace between the Popliteal Artery and Capsule of the Posterior Knee) Block in an Enhanced Recovery after Surgery Pathway for Total Knee Arthroplasty-A Prospective Triple-Blinded Randomized Controlled Trial. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Using the iPACK block to reduce chronic pain in a patient with knee osteoarthritis: A case report. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of the iPACK block injectate spread: a cadaveric study. [2019]

6. Sweden pubmed.ncbi.nlm.nih.gov

Efficacy of adding an interspace block to the posterior knee for perioperative pain in total knee arthroplasty: a randomized controlled trial. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Does the Addition of iPACK Block to Adductor Canal Block Provide Improved Analgesic Effect in Total Knee Arthroplasty? A Systematic Review and Meta-Analysis. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Surgeon-Directed Arthroscopic Infiltration Between the Popliteal Artery and Capsule of the Knee (IPACK) Block: Technical Description. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Infiltration Between Popliteal Artery and Capsule of the Knee Block to Augment Continuous Femoral Nerve Catheter for Adolescent Anterior Cruciate Ligament Reconstruction: A Case Series. [2021]