Suprainguinal Fascia Iliaca Block in Knee Arthroplasty

Analgesia Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06386575
• Other study ID #: suprainguinal
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2024
• Est. completion date: September 1, 2024

Study information

• Verified date: June 2024
• Source: Konya City Hospital
• Contact: MUHAMMED H SATICI, M.D
• Phone: 5455636333
• Email: halit_satici[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia, Local

Intervention

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.
• 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 sfib group will be given 40 milliliters of 0.25 % bupivacaine during the suprainguinal fascia iliaca block.

Locations

Country	Name	City	State
Turkey	Konya City Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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