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Completed

NCT Number: NCT06386575

Suprainguinal Fascia Iliaca Block in Knee Arthroplasty

Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya City Hospital

Konya, 42020, Turkey (Türkiye)

About this study

Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.

The primary purpose of this study is; To evaluate the effects of suprainguinal fascia iliaca block on recovery and recovery in the postoperative period in patients who will undergo total knee arthroplasty surgery, using the quality of recovery-15T score.

Secondary purpose; Postoperative rest and movement numeric rating scale, patient likert scale, first rescue analgesia duration, number of patients needing rescue analgesia, total amount of rescue analgesic consumed, complications such as nausea and vomiting, and antiemetic requirements in patients who will undergo total knee arthroplasty surgery with suprainguinal fascia iliaca block is to evaluate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who will undergo unilateral total knee arthroplasty
  • Patients who will undergo spinal anesthesia
  • Patients aged 18-65 years, ASA I-III
  • Patients who will stay in the hospital for at least 24 hours

Exclusion criteria

  • Patients who do not want to give consent
  • Patients who do not want spinal anesthesia
  • Patients for whom regional anesthesia is contraindicated
  • Patients with confusion
  • Patients with coagulopathy
  • Patients using anticoagulants
  • Patients with infection in the area to be treated
  • Those who are allergic to local anesthesia
  • Emergency cases

Treatment and study plan

control group; Patients who received physiological saline

Other

All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the control group will be given 40 milliliters of physiological saline during the suprainguinal fascia iliaca block.

suprainguinal fascia block; Patients receiving local anesthetic

Other

All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the sfıb group will be given 40 milliliters of 0.25 % bupivacaine during the suprainguinal fascia iliaca block.

Primary outcomes

  1. quality of recovery-15T

    Time frame: One day

    Quality of recovery-15T scores, which show the quality of recovery of the patients, will be recorded at the 24th hour after the surgery. Quality of recovery-15T (0-150, 0= lowest degree of satisfaction, 150= highest degree of satisfaction).

Sponsors and collaborators

Lead sponsor

Konya City Hospital

Other

Registry information

Official study title

Effect of Supra-inguinal Fascia Iliaca Block on Recovery and Recovery Quality After Total Knee Arthroplasty: A Multicenter, Prospective Randomized Controlled, Double-blind Study.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2024
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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