- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06436105
Comparison of Fasia Iliac Compartment Block and 4in1 Block
Comparison of Perioperative Analgesic Effectiveness of Patients Who Had Fasia Iliac Compartment Block and 4in1 Block Applied in Total Knee Prosthesis Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Ankara, Turkey, 06450
- Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Group Control
Peripheral nerve block will not be performed on Group Control patients.
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Peripheral nerve block will not be performed on Group Control patients.
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|
Other: Group FICB
FICB will be performed with 30 ml %0.25 bupivacaine for Group FICB patients.
|
FICB is applied to the patients after spinal anesthesia.
|
|
Other: Group 4 IN 1
4 in 1 block will be performed with 30 ml %0.25 bupivacaine for Group 4 IN 1 patients.
|
4 in 1 block is applied to the patients after spinal anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total tramadol consumption in 24 hours (mg)
Time Frame: 24 hours postoperatively
|
Total tramadol consumption used in the first 24 hours postoperatively
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24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain on the Numeric Rating Scale (NRS)
Time Frame: 0 hours postoperatively
|
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
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0 hours postoperatively
|
|
Pain on the Numeric Rating Scale (NRS)
Time Frame: 1 hours postoperatively
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NRS range was from 0-10 with being no pain and 10 the worst pain possible.
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1 hours postoperatively
|
|
Pain on the Numeric Rating Scale (NRS)
Time Frame: 4 hours postoperatively
|
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
|
4 hours postoperatively
|
|
Pain on the Numeric Rating Scale (NRS)
Time Frame: 8 hours postoperatively
|
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
|
8 hours postoperatively
|
|
Pain on the Numeric Rating Scale (NRS)
Time Frame: 12 hours postoperatively
|
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
|
12 hours postoperatively
|
|
Pain on the Numeric Rating Scale (NRS)
Time Frame: 24 hours postoperatively
|
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
|
24 hours postoperatively
|
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Rescue Analgesic
Time Frame: 24 hours postoperatively
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Consumption of rescue analgesic used after 24 hours postoperatively.
|
24 hours postoperatively
|
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Patient satisfaction
Time Frame: 24 hours postoperatively
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The patient is satisfied or dissatisfied
|
24 hours postoperatively
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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):1134-1141. doi: 10.23736/S0375-9393.18.12062-1. Epub 2018 Jan 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- İsa Öteleş
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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