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

NCT07092982 | Recruiting

• 1 other identifier: 56
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption

  Tramadol consumption will be recorded for 24 hours.

  24 hours

Secondary Outcomes (6)

• Numeric rating scale for pain

  Up to 24 hours

• Time to first postoperative analgesic requirement

  Up to 24 hours

• Postoperative quadriceps muscle strength

  Up to 24 hours

• Incidence of postoperative nausea and vomiting

  Up to 24 hours

• Quality of Recovery 15 (QoR-15)

  24 hours

Study Arms (2)

Ultrasound Guided Fascia Iliaca Block

ACTIVE COMPARATOR

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

Procedure: Ultrasound Guided Suprainguinal Fascia Iliaca Block

Ultrasound Guided Adductor Canal Block + iPACK Block

ACTIVE COMPARATOR

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

Procedure: Ultrasound Guided Adductor Canal Block; Procedure: Ultrasound Guided iPACK Block

Interventions

Ultrasound Guided Suprainguinal Fascia Iliaca Block PROCEDURE

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

Ultrasound Guided Fascia Iliaca Block

Ultrasound Guided Adductor Canal Block PROCEDURE

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

Ultrasound Guided Adductor Canal Block + iPACK Block

Ultrasound Guided iPACK Block PROCEDURE

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

Ultrasound Guided Adductor Canal Block + iPACK Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• SB Istanbul Education and Research Hospital: lead

Study Sites (1)

SB Istanbul Education and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Links

• Related Info

Central Study Contacts

Kubilay Ekinci, MD

CONTACT

0905062671972; kubilay.ekinci@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology and Reanimation Resident

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: July 30, 2025
• Study Start: August 4, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 3 years after the publication of results

Locations

TU (1)