Menu
Recruiting NCT07092982

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

No phase Interventional Total Knee Arthroplasty Ultrasound Guided Supra-inguinal Fascia Iliaca Block Adductor Canal Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound Guided Suprainguinal Fascia Iliaca Block, Ultrasound Guided Adductor Canal Block, Ultrasound Guided iPACK Block.
Who it may be relevant to
Registry conditions: Total Knee Arthroplasty, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Adductor Canal Block. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of the Effects of Ultrasound-Guided Adductor Canal Block With iPACK (Space Between the Popliteal Artery and the Posterior Knee Capsule) Block Combination and Suprainguinal Fascia Iliaca Block on Postoperative Pain and Stress Response in Patients Undergoing Total Knee Arthroplasty

Overview

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.

Interventions

  • Procedure Ultrasound Guided Suprainguinal Fascia Iliaca Block
    Ultrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25
  • Procedure Ultrasound Guided Adductor Canal Block
    Ultrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25
  • Procedure Ultrasound Guided iPACK Block
    Ultrasound Guided iPACK Block, 15ml Bupivacain %0,25

Primary outcome measures

  • Cumulative opioid consumption [Time frame: 24 hours]
Secondary outcome measures (6)
  • Numeric rating scale for pain [Time frame: Up to 24 hours]
  • Time to first postoperative analgesic requirement [Time frame: Up to 24 hours]
  • Postoperative quadriceps muscle strength [Time frame: Up to 24 hours]
  • Incidence of postoperative nausea and vomiting [Time frame: Up to 24 hours]
  • Quality of Recovery 15 (QoR-15) [Time frame: 24 hours]
  • Inflammatory marker levels [Time frame: Up to 24 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • SB Istanbul Education and Research Hospital — Istanbul

Identifiers

NCT: NCT07092982 · 56

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗