78 Participants Needed

IPACK Block for Postoperative Pain After ACL Surgery

JM
Overseen ByJohn Miller, MD
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: Loyola University
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.13467

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.148910

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.
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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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IPACKExperimental Treatment1 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: PlaceboPlacebo Group1 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.

Find a Clinic Near You

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.
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.
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.
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]

References

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]
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]
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]
Using the iPACK block to reduce chronic pain in a patient with knee osteoarthritis: A case report. [2021]
Evaluation of the iPACK block injectate spread: a cadaveric study. [2019]
Efficacy of adding an interspace block to the posterior knee for perioperative pain in total knee arthroplasty: a randomized controlled trial. [2022]
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]
Surgeon-Directed Arthroscopic Infiltration Between the Popliteal Artery and Capsule of the Knee (IPACK) Block: Technical Description. [2023]
Infiltration between the popliteal artery and the capsule of the knee (IPACK) block in knee surgery: a narrative review. [2021]
10.United Statespubmed.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]
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