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Completed

NCT Number: NCT06065878

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa Uludag University

Bursa, 16059, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IPACK + Genicular Nerve Block

Procedure

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

Primary outcomes

  1. Pain Scores- Visual Analog Scale scores

    Time frame: Postoperatively 0 minute, 30th minute , 60th minute , 2nd hour, 4th hour, 8th hour, 12th hour and 24th hour

    Visual Analog Scale scores. 0 to 10 scale. 0 is no pain and 10 is the worst pain.

Secondary outcomes

  1. Time to First Analgesic Requirement

    Time frame: Postoperative 24 hours

    the time to first rescue analgesic requirement was recorded and referred to as the analgesic time

  2. Patient and Surgeon Satisfaction- 5 point Likert scale

    Time frame: Postoperative 24th hour.

    5 point Likert scale is from 1 to 5. 1 is Very Dissatisfied, 5 is very Satisfied.

  3. Mobilization Time

    Time frame: Postoperative 24 hours

    The time elapsed until the patient could stand up and start walking with or without support was recorded as the mobilization time

Sponsors and collaborators

Lead sponsor

Cenk Gacemer

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 4, 2023
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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