Comparison of Two Different Regional Anesthetic Methods in Total Knee Arthroplasty Patients

NCT ID: NCT07092982

Last Updated: 2025-07-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-04
• Study Completion Date: 2026-04-30

Brief Summary

Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. This can result in delayed physical therapy, prolonged hospital stays, the development of nosocomial infections, and impaired cognitive function. All of these factors contribute to increased patient care costs. Multimodal analgesia methods are used to control this pain. One of these methods is peripheral nerve blocks. Peripheral nerve blocks provide pain control and reduce the likelihood of opioid use and related side effects such as nausea, vomiting, and constipation. Current studies recommend Adductor Canal Blocks and iPACK (space between the popliteal artery and the posterior knee capsule) blocks for Total Knee Arthroplasty patients. In addition, studies are also being conducted on the application of the Suprainguinal Fascia-Iliaca Block in Total Knee Arthroplasty patients. The differences in postoperative analgesic effects between these methods are a matter of interest. No study has been conducted comparing the effects of these two approaches, which are routinely applied in our clinic and comply with guidelines, on the postoperative stress response. Regional anesthesia provides adequate pain control and has a positive effect on the stress response. The investigators aim to see a similar effect in peripheral nerve blocks. Therefore, comparing the methods that mentioned will contribute to the literature. In this study, the effects of these two different approaches on postoperative stress response and analgesic efficacy will be compared in terms of patients' postoperative opioid consumption, pain at rest and with movement, time to first analgesic need and development of motor block. IL-6 and CRP values will be examined pre-operatively and post-operatively to measure the effects on the stress response.

Conditions

Total Knee Arthroplasty; Ultrasound Guided Supra-inguinal Fascia Iliaca Block; Adductor Canal Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ultrasound Guided Fascia Iliaca Block

Suprainguinal fascia iliaca block was applied to the patients in this group at the end of the operation.

Group Type: ACTIVE_COMPARATOR

Ultrasound Guided Suprainguinal Fascia Iliaca Block

Intervention Type: PROCEDURE

Ultrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25

Ultrasound Guided Adductor Canal Block + iPACK Block

Adductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation.

Group Type: ACTIVE_COMPARATOR

Ultrasound Guided Adductor Canal Block

Intervention Type: PROCEDURE

Ultrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25

Ultrasound Guided iPACK Block

Intervention Type: PROCEDURE

Ultrasound Guided iPACK Block, 15ml Bupivacain %0,25

Interventions

Ultrasound Guided Suprainguinal Fascia Iliaca Block

Ultrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25

Intervention Type: PROCEDURE

Ultrasound Guided Adductor Canal Block

Ultrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25

Intervention Type: PROCEDURE

Ultrasound Guided iPACK Block

Ultrasound Guided iPACK Block, 15ml Bupivacain %0,25

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing total knee arthroplasty
• Patients aged 18-75
• Patients with ASA I-II-III

Exclusion Criteria

• Coagulation disorders
• Allergy to local anesthetics
• Liver and renal failure
• Alcohol and drug addiction
• Cognitive dysfunction that may prevent pain assessment
• Systemic or needle insertion site infection
• Analgesic use for more than 3 months
• Patient refusal to participate in the study/refusal to consent
• Presence of a hematoma, hernia, neoplasm, etc. in the area where the block will be performed
• Pre-existing neurological deficit
• Patients with contraindications to nerve block

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SB Istanbul Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kubilay Ekinci

Anesthesiology and Reanimation Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

SB Istanbul Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Kubilay Ekinci, MD

Role: CONTACT

kubilay.ekinci@sbu.edu.tr

0905062671972

Facility Contacts

Kubilay Ekinci, MD

Role: primary

kubilay.ekinci@sbu.edu.tr

0905062671972

Related Links

https://journals.lww.com/anesthesia-analgesia/abstract/2019/08000/addition_of_infiltration_between_the_popliteal.36.aspx

Related Info

Other Identifiers

56

Identifier Type: -

Identifier Source: org_study_id