Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty

Analgesia Clinical Trial

Official title:

Ultrasound Guided Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty: Prospective Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05636449
• Other study ID #: ataunikneesurgery
• Status: Completed
• Phase: N/A
• Start date: November 25, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: June 2023
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints.

Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the advancement of surgical techniques and pharmacological treatments.

Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially in hip surgeries. In this way, the investigators think it can be used as a part of multimodal analgesia in total knee arthroplasty surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 30, 2023
• Est. primary completion date: May 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologist's physiologic state I-III patients

• Total knee arthroplasty

Exclusion Criteria:

• BMI>35

• liver, kidney, and advanced heart failure,

• routine use of analgesics and

• having used analgesics in the last 24 hours,

• having neuropathic pain,

• refusal to participate in the study

Related Conditions & MeSH terms

• Analgesia

Intervention

Other:
• Group Suprainguinal fascia iliaca block
After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.
• Group Periarticular Infiltration
A total volume of 80 ml local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon.

Locations

Country	Name	City	State
Turkey	Ali Ahiskalioglu	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bravo D, Layera S, Aliste J, Jara A, Fernandez D, Barrientos C, Wulf R, Munoz G, Finlayson RJ, Tran Q. Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial. J Clin Anesth. 2020 Nov;66:109907. doi: 10.1016/j.jclinane.2020.109907. Epub 2020 Jun 2. — View Citation

Suarez JC, Al-Mansoori AA, Kanwar S, Semien GA, Villa JM, McNamara CA, Patel PD. Effectiveness of Novel Adjuncts in Pain Management Following Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2018 Jul;33(7S):S136-S141. doi: 10.1016/j.arth.2018.02.088. Epub 2018 Mar 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	First 24 hours total fentanyl consumption with patient controlled analgesia	first 24 hours
Secondary	Visual analog pain score	Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score	first 48 hours
Secondary	timed up and go test (TUG)	TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again	at 24th hour
Secondary	quadriceps muscle strength	will be evaluated in a scale between 1-5 (1:lowest; 5:normal)	at 24th hour
Secondary	joint range of motion test (ROM)	will be measured with goniometer( between 0-180 degrees)	at 24th hour
Secondary	Five Time Sit to Stand Test (FTSST)	physical assistance of the patient getting up and sitting down 'as fast as possible' five times without	at 24th hour