Suprainguinal Fascia Iliaca Block in Knee Arthroplasty

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

Study Overview

• Status: Completed
• Conditions: Analgesia; Anesthesia, Local
• Intervention / Treatment: Other: control group; Patients who received physiological saline; Other: suprainguinal fascia block; Patients receiving local anesthetic

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey, 42020
    • Konya City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group	Other: control group; Patients who received physiological saline; 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.
Active Comparator: suprainguinal fascia iliaca block	Other: suprainguinal fascia block; Patients receiving local anesthetic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of recovery-15T	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).	One day

Collaborators and Investigators

• Sponsor: Konya City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Actual): August 3, 2024

Study Registration Dates

• First Submitted: April 15, 2024
• First Submitted That Met QC Criteria: April 22, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: suprainguinal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No