Comparison Of The Analgesic Efficacy Of IPACK (Interspace Between The Popliteal Artery And Capsule Of The Posterior Knee) Block Alone And IPACK Block Combined With Genicular Block In Patients Planned For Total Knee Arthroplasty

NCT ID: NCT06065878

Last Updated: 2023-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2023-06-01

Brief Summary

The IPACK (interspace between the popliteal artery and capsule of the posterior knee) block is a regional anesthesia technique in which a local anesthetic is infiltrated under ultrasound guidance between the popliteal artery and the capsule of the posterior knee. This technique blocks the branches of the obturator nerve, the common peroneal nerve, and the tibial nerve in the popliteal region. In the context of knee arthroplasty, the application of the IPACK block has been associated with lower scores for ambulatory pain, lower scores for resting pain, and reduced morphine consumption .

The genicular nerves, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve, comprise the five main innervation branches of the knee. Clinically, they play an important role in the anterior sensory innervation of the knee.

In the study, the investigators aimed to prospectively, double-blind, and randomly compare the postoperative analgesic efficacy of combined IPACK block and genicular block with the sole application of IPACK block in patients undergoing total knee arthroplasty (TKA). The investigators hypothesized that in blocks performed with equal volumes, there might be a spread of the local anesthetic solution from the IPACK block area to the genicular block area, and the investigators investigated this hypothesis.

Detailed Description

Chronic knee pain, observed in the range of 7-33% in the society, is often caused by osteoarthritis. The knee joint consists of four bones: the femur, tibia, the largest sesamoid bone called the patella, and the fibula, although it does not directly join the joint. It is divided into three compartments called the medial tibiofemoral, lateral tibiofemoral, and patellofemoral, which share a common synovial cavity. Additionally, the knee joint is composed of the patellofemoral and tibiofemoral joints. The knee joint is supported by ligaments that provide stability and muscles and tendons that maintain its dynamic structure.

The superomedial quarter of the anteromedial aspect of the knee joint is innervated by the nervus vastus medialis, the medial branch of the nervus vastus intermedius, and the superior medial genicular nerve. The inferomedial quarter is innervated by the infrapatellar branch of the saphenous nerve and the inferior medial genicular nerve. The superolateral quarter of the anterolateral aspect is innervated by the nervus vastus lateralis, the lateral branch of the nervus vastus intermedius, the superior lateral genicular nerve, and the articular branches of the common fibular nerve. The inferolateral portion is innervated by the inferior lateral genicular nerve and the recurrent fibular nerve. The posterior sensation of the knee is provided by the popliteal plexus. Due to the dense innervation of the knee joint, approximately 60% of patients undergoing knee prostheses experience severe pain, while 30% describe a moderate level of pain.

The IPACK (interspace between the popliteal artery and capsule of the posterior knee) block is a regional anesthesia technique in which a local anesthetic is infiltrated under ultrasound guidance between the popliteal artery and the capsule of the posterior knee. This technique blocks the branches of the obturator nerve, the common peroneal nerve, and the tibial nerve in the popliteal region. In the context of knee arthroplasty, the application of the IPACK block has been associated with lower scores for ambulatory pain, lower scores for resting pain, and reduced morphine consumption .

The genicular nerves, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve, comprise the five main innervation branches of the knee. Clinically, they play an important role in the anterior sensory innervation of the knee. GNB (genicular nerve block) and radiofrequency ablation techniques are utilized in the treatment of chronic osteoarthritis and have recently gained popularity in postoperative pain management following knee surgeries.

In our study, the investigators aimed to prospectively, double-blind, and randomly compare the postoperative analgesic efficacy of combined IPACK block and genicular block with the sole application of IPACK block in patients undergoing total knee arthroplasty (TKA). The investigators hypothesized that in blocks performed with equal volumes, there might be a spread of the local anesthetic solution from the IPACK block area to the genicular block area, and the investigators investigated this hypothesis.

Conditions

Pain, Joint; Knee Arthropathy; Anesthesia; Orthopedic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

IPACK block

In the IPACK block group, a 20 mL solution containing 50 mg of 0.25% bupivacaine (Buvicaine®, Polifarma, Tekirdağ, Turkey) and 8 mg of dexamethasone (Dekort®, Deva, Istanbul, Turkey) was infiltrated between the popliteal artery and femur, starting 2 cm distal to the popliteal artery and being withdrawn while infiltrating proximally.

Group Type: NO_INTERVENTION

No interventions assigned to this group

IPACK + Genicular Nerve Block

In the IPACK+GNB group, 12 mL of the same solution was used for the IPACK block infiltration. Then, the patient was positioned supine, and an ultrasound (Logiq e®, GE, Boston, USA) linear probe was placed approximately 2-3 cm above the patella, in the midline of the femur, with a sagittal plane angle of 45 degrees to visualize the femur and genicular artery . The visible needle was advanced in-plane towards the genicular artery, and 4 mL of local anesthetic solution was injected on the surface of the femur. The same procedure was repeated for the superior lateral genicular nerve block, creating a mirror image on the lateral side of the femur.

Group Type: ACTIVE_COMPARATOR

IPACK + Genicular Nerve Block

Intervention Type: PROCEDURE

IPACK and Genicular Nerve block were applied with the same total volume of local anesthetic as the control group.

Interventions

IPACK + Genicular Nerve Block

IPACK and Genicular Nerve block were applied with the same total volume of local anesthetic as the control group.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Unilateral total knee arthroplasty
• Between the ages of 18 and 80,
• Classified as American Society of Anesthesiologists (ASA) class I-III

Exclusion Criteria

• Patients under 18 years old or over 80
• ASA scores IV and above,
• pregnant or suspected of being pregnant,
• allergic to local anesthetics,
• coagulopathy,
• injection site infection,
• significant neurological or psychiatric disorders,
• severe cardiovascular diseases,
• chronic opioid use

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cenk Gacemer

OTHER

Sponsor Role: lead

Responsible Party

Cenk Gacemer

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bursa Uludag University

Bursa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

A. Fırat, K. Başarır, and M. Binnet, Türk Ortopedi ve Travmatoloji Birliği Derneği Diz ekleminin cerrahi anatomisi, TOTBİD Dergisi, 2011; 10 (1): 38-44

Reference Type: BACKGROUND

GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.

Reference Type: BACKGROUND

PMID: 18915634 (View on PubMed)

Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.

Reference Type: BACKGROUND

PMID: 28861197 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 36572894 (View on PubMed)

Kukreja P, Venter A, Mason L, Kofskey AM, Northern T, Naranje S, Ghanem E, Lawson PA, Kalagara H. Comparison of Genicular Nerve Block in Combination With Adductor Canal Block in Both Primary and Revision Total Knee Arthroplasty: A Retrospective Case Series. Cureus. 2021 Jul 29;13(7):e16712. doi: 10.7759/cureus.16712. eCollection 2021 Jul.

Reference Type: BACKGROUND

PMID: 34471571 (View on PubMed)

Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.

Reference Type: BACKGROUND

PMID: 31407791 (View on PubMed)

Elsaman AM, Maaty A, Hamed A. Genicular nerve block in rheumatoid arthritis: a randomized clinical trial. Clin Rheumatol. 2021 Nov;40(11):4501-4509. doi: 10.1007/s10067-021-05821-5. Epub 2021 Jul 2.

Reference Type: BACKGROUND

PMID: 34213672 (View on PubMed)

Tran J, Giron Arango L, Peng P, Sinha SK, Agur A, Chan V. Evaluation of the iPACK block injectate spread: a cadaveric study. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100355. doi: 10.1136/rapm-2018-100355. Online ahead of print.

Reference Type: BACKGROUND

PMID: 31061110 (View on PubMed)

Other Identifiers

IPACKvsIPACK&GNB

Identifier Type: -

Identifier Source: org_study_id