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

NCT06586840 | Recruiting

• 1 other identifier: 2023/07/01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain, Acute

Keywords

adductor canal block; knee arthroplasty; ipack

Outcome Measures

Primary Outcomes (1)

• The primary outcome will be the comparison of discharge times between patients undergoing total knee arthroplasty who receive an adductor canal block with and without the addition of an iPACK block.

  Total Knee Arthroplasty surgery results in shorter hospital stays

  Until discharge after surgery(Up to 6 days after the surgery)

Secondary Outcomes (1)

• The secondary outcome will be the assessment of whether the addition of an iPACK block to the adductor canal block reduces postoperative opioid consumption and pain scores by 50%, which will be considered significant.

  Acute pain will be assessed after surgery until discharge(Up to 6 days after the surgery)

Study Arms (2)

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.

Other: rescue analgesia; Procedure: Adductor Canal Block

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.

Other: rescue analgesia; Procedure: Adding an IPACK Block to the Adductor Canal Block

Interventions

rescue analgesia 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; Adductor Canal Block

Adductor Canal Block 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.

Adductor Canal Block

Adding an IPACK Block to the Adductor Canal Block 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.

Adding an IPACK Block to the Adductor Canal Block

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Once eligibility is confirmed, patients will receive complete oral and written information about the study. Informed consent will be obtained before randomization and study-specific procedures.

You may qualify if:

• Patients with written informed consent
• Patients over 18 years old undergoing elective total knee arthroplasty surgery
• Patients with ASA I-II-III
• Patients receiving spinal anesthesia

You may not qualify if:

• Revision knee arthroplasty and bilateral total knee arthroplasty
• Liver or kidney failure
• Patients under 18 years old
• Patients receiving general anesthesia
• Allergy or intolerance to study medications
• Body mass index (BMI) \> 40 kg/m²
• Chronic use of gabapentin/pregabalin (regular use for more than 3 months)
• Chronic opioid use (opioid use for more than 3 months or daily oral morphine equivalent \> 5 mg/day for 1 month)
• Patients with ASA IV and those undergoing emergency surgery

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Murat Demircioglu

Aydin, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• MURAT DEMİRCİOGLU

  muratdemircioglu01@gmail.com

  STUDY CHAIR

Central Study Contacts

MURAT DEMİRCİOGLU

CONTACT

+905393403222; muratdemircioglu01@gmail.com

MUSTAFA OGURLU

CONTACT

+905326056932; mogurlu@adu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: September 19, 2024
• Study Start: July 10, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)