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

NCT06065878 | Completed

• 1 other identifier: IPACKvsIPACK&GNB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Joint; Knee Arthropathy; Anesthesia; Orthopedic Disorder

Keywords

IPACK Block; Genicular Nerve Block; Total Knee Arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to First Analgesic Requirement

  Postoperative 24 hours

• Patient and Surgeon Satisfaction- 5 point Likert scale

  Postoperative 24th hour.

• Mobilization Time

  Postoperative 24 hours

Study Arms (2)

IPACK block

NO INTERVENTION

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.

IPACK + Genicular Nerve Block

ACTIVE COMPARATOR

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.

Procedure: IPACK + Genicular Nerve Block

Interventions

IPACK + Genicular Nerve Block PROCEDURE

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

IPACK + Genicular Nerve Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cenk Gacemer: lead

Study Sites (1)

Bursa Uludag University

Bursa, 16059, Turkey (Türkiye)

Location

Related Publications (8)

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

  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.

  PMID: 18915634 BACKGROUND

• 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.

  PMID: 28861197 BACKGROUND

• 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.

  PMID: 36572894 BACKGROUND

• 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.

  PMID: 34471571 BACKGROUND

• 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.

  PMID: 31407791 BACKGROUND

• 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.

  PMID: 34213672 BACKGROUND

• 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.

  PMID: 31061110 BACKGROUND

MeSH Terms

Conditions

Arthralgia; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Joint Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 4, 2023
• Study Start: December 7, 2022
• Primary Completion: May 15, 2023
• Study Completion: June 1, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)