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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06065878
• Other study ID #: IPACKvsIPACK&GNB
• Status: Completed
• Phase: N/A
• Start date: December 7, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: September 2023
• Source: Uludag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 1, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Arthralgia
• Knee Arthropathy
• Musculoskeletal Diseases
• Orthopedic Disorder
• Pain, Joint

Intervention

Procedure:
• IPACK + Genicular Nerve Block
IPACK and Genicular Nerve block were applied with the same total volume of local anesthetic as the control group.

Locations

Country	Name	City	State
Turkey	Bursa Uludag University	Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Cenk Gacemer

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

A. Firat, K. Basarir, and M. Binnet, Türk Ortopedi ve Travmatoloji Birligi Dernegi Diz ekleminin cerrahi anatomisi, TOTBID Dergisi, 2011; 10 (1): 38-44

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Xiumei T, Yahao L, Siwei D, Ning N. Correction: Analgesic efficacy of adding the IPACK block to multimodal analgesia protocol for primary total knee arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Dec 26;17(1):565. doi: 10.1186/s13018-022-03460-3. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Scores- Visual Analog Scale scores	Visual Analog Scale scores. 0 to 10 scale. 0 is no pain and 10 is the worst pain.	Postoperatively 0 minute, 30th minute , 60th minute , 2nd hour, 4th hour, 8th hour, 12th hour and 24th hour
Secondary	Time to First Analgesic Requirement	the time to first rescue analgesic requirement was recorded and referred to as the analgesic time	Postoperative 24 hours
Secondary	Patient and Surgeon Satisfaction- 5 point Likert scale	5 point Likert scale is from 1 to 5. 1 is Very Dissatisfied, 5 is very Satisfied.	Postoperative 24th hour.
Secondary	Mobilization Time	The time elapsed until the patient could stand up and start walking with or without support was recorded as the mobilization time	Postoperative 24 hours