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Total Knee ArthroplastyNCT06686095

Analgesic Effect of Adductor Canal Block, IPACK Block, and Genicular Nerve Block

A study testing Group Adductor canal block, Group Genicular Nerve Block and Group IPACK Block in people with Total Knee Arthroplasty, run by Hitit University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients with total knee arthroplasty (TKA) experience severe postoperative pain. This reduces patient satisfaction, delays mobility, and prolongs hospital stay. Peripheral nerve blocks, which are part of multimodal analgesia, are widely used in postoperative pain management. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Total Knee Arthroplasty
What is being tested?
Group Adductor canal block, Group Genicular Nerve Block and Group IPACK Block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Oct 2022to 15 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ASA I-II-III
  • BMI < 40
  • 18-80 years old

Who cannot join

  • ASA IV-V
  • <18 years, >80 years
  • Will undergo revision TKA surgery
  • Will undergo bilateral TKA surgery
  • BMI > 40
  • Patients who used high dose opioid medication within 3 days before surgery
  • those with widespread chronic pain, diabetes mellitus, a history of neuromuscular disease, hepatic and renal failure
  • who underwent general anesthesia during the intraoperative period

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hitit University Erol Olcok Training and Research Hospital

    Çorum, 19200

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Analgesic Effect of Adductor Canal Block, IPACK, and Genicular Nerve Block Following Total Knee Arthroplasty Under Spinal Anesthesia

Patients with total knee arthroplasty (TKA) experience severe postoperative pain. This reduces patient satisfaction, delays mobility, and prolongs hospital stay. Peripheral nerve blocks, which are part of multimodal analgesia, are widely used in postoperative pain management. In this study, the effects of adductor canal block (ACB), popliteal artery and knee capsule infiltration block (IPACK), and genicular nerve block (GSB) on postoperative VAS score, opioid consumption, and mobility were investigated.

Read the detailed description

Total knee arthroplasty (TKA) is a surgical procedure performed on patients with severe pain and severely limited range of motion in the knee joint due to knee osteoarthritis, when traditional conservative treatments have failed. Fifty-eight percent of patients who undergo TKA experience moderate or severe pain in the postoperative period. Inadequate pain control leads to complications such as venous thrombosis, coronary ischemia, myocardial infarction, and pneumonia, and increases morbidity. In addition, failure to control postoperative pain negatively affects physical therapy procedures. This situation prolongs the rehabilitation and hospital stay of patients, thus increasing care costs. Therefore, it is of great importance to reduce the patient's pain after TKA.

Femoral nerve block (FNB) has traditionally been a critical component of multimodal analgesia in TKA due to its high analgesic efficacy. However, FNB limits physical therapy by causing motor limitations in the quadriceps muscle. This situation causes delays in ambulation and discharge. Due to the difficulties in rehabilitation observed in patients undergoing FNB due to quadriceps muscle weakness, different techniques were sought and the Adductor canal block (ACB) emerged. AKB is a sensory block that blocks the saphenous nerve, a sensory nerve that courses in the adductor canal in the thigh, thus preserving motor function. It is an alternative block to FNB by providing adequate analgesia to the anterior compartment of the knee.

Genicular nerves include branches of the femoral, common peroneal, saphenous, tibial and obturator nerves that innervate the knee capsule. It is known that the superolateral, superomedial and inferomedial branches of the genicular nerve are close to the periosteum of the tibia and femur and play a role in sensory innervation of the anterior part of the knee joint. Genicular nerve block (GNB) is used in chronic osteoarthritis pain and has been used in recent years to relieve postoperative pain in TKA.

Infiltration between Popliteal Artery and Capsule of the Knee (IPACK block) is performed by infiltrating local anesthetic (LA) between the popliteal artery and the knee capsule under USG guidance. The sciatic nerve has an important function in the motor and sensory innervation of the posterior leg. In the IPACK block application, the LA spreads along the popliteal fossa and proximal sciatic nerve involvement does not occur. Thus, the sensory nerve network innervating the posterior part of the knee is blocked. Since IPACK block provides only sensory block without causing motor block, it is a new method recommended for analgesia in knee surgery as an alternative to sciatic nerve block, which causes motor block.

Method:

Exclusion criteria from the study were: patient refusal to participate in the study, patients with ASA physical classification 4-5, revision TKA, simultaneous bilateral TKA, patients younger than 18 years and older than 80 years, BMI >40, allergy to the local anesthetic used, DM, hepatic and renal failure, alcohol and drug addiction, high-dose opioid drug use within 3 days before surgery, peripheral nerve disease, patients who could not score pain with the VAS system, patients with contraindications to spinal anesthesia and peripheral nerve block.

Adductor canal block procesure: Before the procedure, the patient will be informed about the technique and a signed consent will be obtained from the patient. The patient's hip will be slightly externally rotated and the ultrasonography linear probe will be placed on the medial aspect of the thigh, at the midpoint of the patella and vastus medialis. After the femoral artery is visualized at a depth of approximately 3-4 centimeters (cm) from the distal short axis angle, if the artery cannot be identified, the femoral artery, which is visualized in the inguinal region, can be followed distally starting from the proximal and the pulsatile flow of the artery will be seen in the doppler mode. After the vastus medialis and sartorius muscles are visualized, the superficial femoral artery is centered at the midpoint of the sartorius muscle. At this point, the roof of the adductor canal can be visualized. After the saphenous nerve and vastus medianus nerve are seen as small round hyperechoic structures, the needle is inserted with the in plane technique and advanced towards the anterolateral aspect of the superficial femoral artery. Then, 5-20 milliliters (mL) of LA is administered into the adductor canal.

Genicular Nerve Block: Before the procedure, the patient is informed about the technique and approval is obtained from the patient. A pillow is placed in the popliteal fossa of the patient lying in the supine position and the knee is slightly flexed. For superior lateral Genicular nerve blockade; the linear USG probe is placed on the lateral epicondyle of the femur in the coronal plane and moved proximally to visualize the metaphysis of the bone. At this level, the superolateral genicular artery can be seen between the deep fascia of the vastus lateralis and the femur. With the in-plane or out-of-plane technique, the peripheral block needle is advanced from the side of the artery until it touches the bone surface and 4-5 mL of LA medication is injected. For superior medial Genicular nerve blockade; the linear USG probe is placed on the medial epicondyle of the femur in the coronal direction and moved proximally to visualize the metaphysis of the bone in front of the adductor tubercle. The superior medial Genicular artery is seen between the femur and the deep fascia of the vastus medialis muscle. The peripheral block needle is inserted from the side of the artery until it touches the bone surface with an in-plane or out-of-plane technique and 4-5 ml of LA drug is injected. A linear USG probe placed coronally on the medial condyle of the tibia is moved distally to visualize the bone metaphysis. The inferomedial genicular artery can be seen under the medial collateral ligament. The peripheral block needle is inserted from the side of the artery until it touches the bone surface with an in-plane or out-of-plane technique and 4-5 ml of LA drug is injected. A negative aspiration test is performed before injecting LA drug in all blocks.

IPACK Block: Before the procedure, the patient is informed about the technique and written consent is obtained from the patient. The patient lies in the prone position. The linear USG probe is placed approximately 2-3 cm above the popliteal fossa and scanned distally to identify the femoral shaft and popliteal artery. If the femoral condyles are initially visualized, the probe is moved until the condyles disappear and the femoral shaft is identified as a straight line and hyperechoic. Color doppler can be used to identify the popliteal vessels. The peripheral block needle is advanced between the femoral shaft and the popliteal artery. After negative aspiration control, 15-20 mL of LA medication is injected here.

Being tested
Group Adductor canal block, Group Genicular Nerve Block, Group IPACK Block
Keywords
Total Knee Arthroplasty, Adductor Canal Block, Ipack block, Genicular nerve block, Post-Operative Pain, Peripheral Nerve Block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group Adductor canal blockProcedure or surgery

    Adductor canal block procedure: The patient will be informed about the technique and consent will be obtained. The patient's hip will be slightly externally rotated, and an ultrasonography linear probe will be placed on the medial thigh, at the midpoint of the patella and vastus medialis. After locating the femoral artery at approximately 3-4 cm depth, if not visible, the artery can be traced distally from the inguinal region using Doppler mode. Once the vastus medialis and sartorius muscles are identified, the superficial femoral artery is centered at the midpoint of the sartorius muscle. The adductor canal roof, along with the saphenous and vastus medialis nerves, appears as hyperechoic structures. A needle is inserted in-plane, advancing toward the anterolateral femoral artery aspect, and 5-20 mL of LA is injected.

  • Group Genicular Nerve BlockProcedure or surgery

    Genicular Nerve Block: The patient is informed and consent is obtained. With a pillow in the popliteal fossa, the knee is slightly flexed. For the superior lateral genicular nerve, a linear USG probe is positioned on the lateral femoral epicondyle, moving proximally to visualize the bone metaphysis. The superolateral artery is seen between the vastus lateralis fascia and the femur. Using in-plane or out-of-plane technique, the needle is guided to the bone, and 4-5 mL of LA is injected. For the superior medial nerve, the probe is placed on the medial epicondyle and moved proximally to visualize the bone near the adductor tubercle. The artery lies between the femur and vastus medialis fascia. For the inferomedial artery, the probe is placed on the tibial medial condyle, moving distally. A negative aspiration test is conducted before each LA injection.

  • Group IPACK BlockProcedure or surgery

    IPACK Block: Before the procedure, the patient is informed about the technique and written consent is obtained from the patient. The patient lies in the prone position. The linear USG probe is placed approximately 2-3 cm above the popliteal fossa and scanned distally to identify the femoral shaft and popliteal artery. If the femoral condyles are initially visualized, the probe is moved until the condyles disappear and the femoral shaft is identified as a straight line and hyperechoic. Color doppler can be used to identify the popliteal vessels. The peripheral block needle is advanced between the femoral shaft and the popliteal artery. After negative aspiration control, 15-20 mL of LA medication is injected here.

Study groups in NCT06686095
Study groupRoleWhat they receive
Group Adductor canal blockActive comparatorPatients who underwent adductor canal block
Receives: Procedure: Group Adductor canal block
Group IPACK BlockActive comparatorPatients who underwent Infiltration between Popliteal Artery and Capsule of the Knee block
Receives: Procedure: Group IPACK Block
Group Genicular Nerve BlockActive comparatorPatients who underwent Genicular nerve block
Receives: Procedure: Group Genicular Nerve Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Examination with Numeric Rating Scale

    Determination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and >8=intolerable pain).

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2024
  2. Study start1 Oct 2022
  3. Primary completion1 Feb 2023
  4. Study completion15 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Group A (n=30): Patients who underwent adductor canal block , group I (n=30): Patients who underwent infiltration block between popliteal artery and knee capsule block, group G (n=30): Patients who underwentgenicular nerve block
Masking
Single blind
Who is masked
Participant
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06686095
Sponsor's protocol ID
2022-81
Status last verified
Nov 2024
First submitted
7 Nov 2024
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Group Adductor canal block, Group Genicular Nerve Block and Group IPACK Block in people with Total Knee Arthroplasty, run by Hitit University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Examination with Numeric Rating Scale (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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