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

September 26, 2023 updated by: Cenk Gacemer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bursa, Turkey, 16059
        • Bursa Uludağ University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.
Procedure: IPACK + Genicular Nerve Block
IPACK and Genicular Nerve block were applied with the same total volume of local anesthetic as the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Postoperatively 0 minute, 30th minute , 60th minute , 2nd hour, 4th hour, 8th hour, 12th hour and 24th hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Postoperative 24 hours
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.
Postoperative 24th hour.
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
Postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cenk Gacemer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 7, 2022

Primary Completion (Actual)

May 15, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPACKvsIPACK&GNB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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