The Effect of Adding an IPACK Block to the Adductor Canal Block on Total Knee Arthroplasty Surgery

NCT ID: NCT06586840

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-04-01

Brief Summary

Total knee arthroplasty (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to prolonged hospital stay. Optimal postoperative knee analgesia is crucial not only for patient comfort and satisfaction but also for accelerating mobilization, functional recovery, and discharge from the hospital. To facilitate early ambulation and superior performance, multimodal analgesia and motor-sparing blocks are increasingly utilized

Detailed Description

In total knee arthroplasty, a pain management method that preserves motor strength is increasingly accepted as part of the perioperative rehabilitation protocol. Although peripheral nerve blocks like the femoral nerve block (FNB) can cause significant loss of quadriceps muscle strength and delayed rehabilitation due to the risk of patient falls, growing evidence supports the use of the Total knee arthroplasty (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to prolonged hospital stay. Optimal postoperative knee analgesia is crucial not only for patient comfort and satisfaction but also for accelerating mobilization, functional recovery, and discharge from the hospital. To facilitate early ambulation and superior performance, multimodal analgesia and motor-sparing blocks are increasingly utilized.

Regional anesthesia techniques are among the most effective methods for postoperative analgesia. Peripheral nerve blocks, a type of regional anesthesia, provide ideal postoperative analgesia due to their ability to offer effective analgesia, reduce opioid requirements and associated side effects, and facilitate recovery by effectively managing dynamic pain.

The innervation of the knee joint is supplied by branches from the femoral nerve, obturator nerve, common peroneal nerve, and tibial nerve, which originate from the lumbar and sacral plexuses responsible for lower extremity innervation.

adductor canal block (ACB) in total knee arthroplasty patients for minimal motor involvement or purely sensory block.

The adductor canal block (ACB) is a predominantly sensory nerve block that includes the saphenous nerve, the nerve to the vastus medialis muscle, and the articular branches of the obturator nerve. When performed successfully, it provides analgesia similar to the femoral nerve block without significant motor loss in the thigh. It is primarily used for lower extremity surgeries such as total knee arthroplasty, anterior cruciate ligament reconstruction, and meniscus repair.

There is increasing interest in the technique called iPACK (infiltration between the popliteal artery and capsule of the knee), which involves injecting local anesthetics into the space between the popliteal artery and the posterior capsule of the knee. This approach blocks the terminal branches of the genicular nerves and the popliteal plexus, which innervate the posterior capsule of the knee, while sparing the main trunks of the tibial and common peroneal nerves. Therefore, the iPACK block appears advantageous by providing motor-sparing posterior knee analgesia with a lower likelihood of nerve or vascular injury under ultrasound guidance. Studies have shown that combining ACB with the iPACK block provides significantly better postoperative numerical rating scale (NRS) scores, knee range of motion, and ambulation distances compared to ACB alone.

Conditions

Postoperative Pain, Acute

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Adductor Canal Block

For Group I, after patients are placed in the supine position, a linear ultrasound probe (13-6 MHz) will be used to identify the superficial femoral artery in the short axis, lateral to the Sartorius muscle, and anterior to the adductor magnus muscle in the adductor canal. A 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially under sterile conditions, and 20 mL of 0.5% bupivacaine will be injected after negative aspiration.

rescue analgesia

Intervention Type: OTHER

. If NRS is 4 or higher in the postoperative recovery room, 100 mg of intravenous tramadol will be administered as rescue analgesia

Adductor Canal Block

Intervention Type: PROCEDURE

For Group I, after patients are placed in the supine position, a linear ultrasound probe (13-6 MHz) will be used to identify the superficial femoral artery in the short axis, lateral to the Sartorius muscle, and anterior to the adductor magnus muscle in the adductor canal. A 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially under sterile conditions, and 20 mL of 0.5% bupivacaine will be injected after negative aspiration.

Adding an IPACK Block to the Adductor Canal Block

For Group II, 20 mL of 0.25% bupivacaine will be injected into the Adductor Canal after spinal anesthesia. With the knee flexed, a convex probe (3.5-6 MHz) will be placed in the popliteal region to identify the popliteal artery in the short axis. The ultrasound probe will be moved distally after the common peroneal and tibial nerves are identified. The probe will be gradually moved towards the popliteal fossa until the popliteal vessels are identified superficially. The ultrasound probe will be moved to the level where the femoral condyles merge with the femoral shaft. The popliteal artery, tibial and peroneal nerves will be visualized to identify the space between the femur and the popliteal artery. In the area known as iPACK, a 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially, and 20 mL of 0.25% bupivacaine will be injected after negative aspiration.

rescue analgesia

Intervention Type: OTHER

. If NRS is 4 or higher in the postoperative recovery room, 100 mg of intravenous tramadol will be administered as rescue analgesia

Adding an IPACK Block to the Adductor Canal Block

Intervention Type: PROCEDURE

For Group II, 20 mL of 0.25% bupivacaine will be injected into the Adductor Canal after spinal anesthesia. With the knee flexed, a convex probe (3.5-6 MHz) will be placed in the popliteal region to identify the popliteal artery in the short axis. The ultrasound probe will be moved distally after the common peroneal and tibial nerves are identified. The probe will be gradually moved towards the popliteal fossa until the popliteal vessels are identified superficially. The ultrasound probe will be moved to the level where the femoral condyles merge with the femoral shaft. The popliteal artery, tibial and peroneal nerves will be visualized to identify the space between the femur and the popliteal artery. In the area known as iPACK, a 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially, and 20 mL of 0.25% bupivacaine will be injected after negative aspiration.

Interventions

rescue analgesia

. If NRS is 4 or higher in the postoperative recovery room, 100 mg of intravenous tramadol will be administered as rescue analgesia

Intervention Type: OTHER

Adductor Canal Block

For Group I, after patients are placed in the supine position, a linear ultrasound probe (13-6 MHz) will be used to identify the superficial femoral artery in the short axis, lateral to the Sartorius muscle, and anterior to the adductor magnus muscle in the adductor canal. A 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially under sterile conditions, and 20 mL of 0.5% bupivacaine will be injected after negative aspiration.

Intervention Type: PROCEDURE

Adding an IPACK Block to the Adductor Canal Block

For Group II, 20 mL of 0.25% bupivacaine will be injected into the Adductor Canal after spinal anesthesia. With the knee flexed, a convex probe (3.5-6 MHz) will be placed in the popliteal region to identify the popliteal artery in the short axis. The ultrasound probe will be moved distally after the common peroneal and tibial nerves are identified. The probe will be gradually moved towards the popliteal fossa until the popliteal vessels are identified superficially. The ultrasound probe will be moved to the level where the femoral condyles merge with the femoral shaft. The popliteal artery, tibial and peroneal nerves will be visualized to identify the space between the femur and the popliteal artery. In the area known as iPACK, a 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially, and 20 mL of 0.25% bupivacaine will be injected after negative aspiration.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Patients with written informed consent

2. Patients over 18 years old undergoing elective total knee arthroplasty surgery

3. Patients with ASA I-II-III

4. Patients receiving spinal anesthesia

Exclusion Criteria

1. Revision knee arthroplasty and bilateral total knee arthroplasty

2. Liver or kidney failure

3. Patients under 18 years old

4. Patients receiving general anesthesia

5. Allergy or intolerance to study medications

6. Body mass index (BMI) > 40 kg/m²

7. Chronic use of gabapentin/pregabalin (regular use for more than 3 months)

8. Chronic opioid use (opioid use for more than 3 months or daily oral morphine equivalent > 5 mg/day for 1 month)

9. Patients with ASA IV and those undergoing emergency surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aydin Adnan Menderes University

OTHER

Sponsor Role: lead

Responsible Party

MURAT DEMİRCİOGLU

doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

MURAT DEMİRCİOGLU

Role: STUDY_CHAIR

muratdemircioglu01@gmail.com

Locations

Murat Demircioglu

Aydin, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

MURAT DEMİRCİOGLU

Role: CONTACT

muratdemircioglu01@gmail.com

+905393403222

MUSTAFA OGURLU

Role: CONTACT

mogurlu@adu.edu.tr

+905326056932

Facility Contacts

MURAT DEMİRCİOGLU

Role: primary

muratdemircioglu01@gmail.com

+905393403222

Other Identifiers

2023/07/01

Identifier Type: -

Identifier Source: org_study_id