COMPARISON OF PERIOPERATIVE ANALGESIC EFFECTIVENESS OF PATIENTS WHO HAD FASIA ILIAC COMPARTMENT BLOCK AND 4IN1 BLOCK APPLIED IN TOTAL KNEE PROSTHESIS SURGERY

Pain, Postoperative Clinical Trial

Official title:

COMPARISON OF PERIOPERATIVE ANALGESIC EFFECTIVENESS OF PATIENTS WHO HAD FASIA ILIAC COMPARTMENT BLOCK AND 4IN1 BLOCK APPLIED IN TOTAL KNEE PROSTHESIS SURGERY

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06436105
• Other study ID #: Isa Öteles
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: May 2024
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.

Description:

Total knee arthroplasty is a surgical procedure performed mostly on patients with osteoarthritis who have failed traditional conservative treatment. Increasing knee osteoarthritis due to reasons such as life expectancy and body mass index causes this surgical procedure to be performed more frequently. The knee joint which is innervated by the femoral, obturator, sciatic nerves and their branches has a complicated innervation and the pain following total knee arthrplasty is quite severe. It is aimed to provide effective analgesia by blocking these nerves or terminal branches with various peripheral nerve blockade methods under USG guidance. In recent years, interest in studies aiming to block these nerves with a single injection has been increasing. 4 in 1 block is a new technique applied from a single injection point to block the saphenous, obturator, sciatic and vastus medialis nerves that innervate the knee joint. Fascia iliaca compartment block is a reliable technique applied from a single injection point to block the femoral, lateral femoral cutaneous and obturator nerves behind the fascia iliaca.

Patients who will undergo elective total knee arthroplasty surgery under spinal anesthesia will be included in the study according to the postoperative analgesia method applied: Group Control, Group FICB and Group 4in1. Peripheral nerve block will be performed with 30 ml %0.25 bupivacaine for Group FICB and Group 4 in 1 patients. Peripheral nerve block will not be performed on Group Control patients. Patient-controlled analgesia will be given to all three groups in the postoperative period. PCA is a pain palliation method routinely used in all patients postoperatively. NRS score, PCA tramadol consumption, PCA demand, need for additional analgesia, patient satisfaction, nausea and vomiting will be monitored 24 hours postoperatively. The aim of this study is to compare the perioperative analgesic effectiveness of patients who underwent fascia iliaca compartment block and 4 in 1 block in total knee arthroplasty surgery, with each other and with the control group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: August 1, 2024
• Est. primary completion date: July 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• With informed consent

• Elective total knee arthroplasty with spinal anesthesia

• Oriented and cooperative

• ASA Classification I-II-III

• 18-85 years old

Exclusion Criteria:

• Anticoagulant medication

• Coagulopathy

• Infection at the site of peripheral nerve block application

• Allergy to local anesthetics

• Pregnant or suspected pregnancy

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Other:
• FICB
FICB is applied to the patients after spinal anesthesia.
• 4 in 1 block
4 in 1 block is applied to the patients after spinal anesthesia.

Locations

Country	Name	City	State
Turkey	Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Kanadli H, Dogru S, Karaman T, Karaman S, Tapar H, Sahin A, Asci M, Kanadli KA, Suren M. Comparison of the efficacy of femoral nerve block and fascia iliaca compartment block in patients with total knee replacement. Minerva Anestesiol. 2018 Oct;84(10):113 — View Citation

Roy R, Agarwal G, Pradhan C, Kuanardr D, Mallick DJ. Ultrasound guided 4 in 1 block - a newer, single injection technique for complete postoperative analgesia for knee and below knee surgeries. Anaesthesia, Pain & Intensive Care. 2018;22(1):87-92.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total tramadol consumption in 24 hours (mg)	Total tramadol consumption used in the first 24 hours postoperatively	24 hours postoperatively
Secondary	Pain on the Numeric Rating Scale (NRS)	NRS range was from 0-10 with being no pain and 10 the worst pain possible.	0 hours postoperatively
Secondary	Pain on the Numeric Rating Scale (NRS)	NRS range was from 0-10 with being no pain and 10 the worst pain possible.	1 hours postoperatively
Secondary	Pain on the Numeric Rating Scale (NRS)	NRS range was from 0-10 with being no pain and 10 the worst pain possible.	4 hours postoperatively
Secondary	Pain on the Numeric Rating Scale (NRS)	NRS range was from 0-10 with being no pain and 10 the worst pain possible.	8 hours postoperatively
Secondary	Pain on the Numeric Rating Scale (NRS)	NRS range was from 0-10 with being no pain and 10 the worst pain possible.	12 hours postoperatively
Secondary	Pain on the Numeric Rating Scale (NRS)	NRS range was from 0-10 with being no pain and 10 the worst pain possible.	24 hours postoperatively
Secondary	Rescue Analgesic	Consumption of rescue analgesic used after 24 hours postoperatively.	24 hours postoperatively
Secondary	Patient satisfaction	The patient is satisfied or dissatisfied	24 hours postoperatively