Pain, PostoperativeNCT06436105
Comparison of Fasia Iliac Compartment Block and 4in1 Block
A study testing FICB and 4 in 1 block in people with Pain, Postoperative, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- FICB and 4 in 1 block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 May 2024to 8 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- With informed consent
- Elective total knee arthroplasty with spinal anesthesia
- Oriented and cooperative
- ASA Classification I-II-III
- 18-85 years old
Who cannot join
- Anticoagulant medication
- Coagulopathy
- Infection at the site of peripheral nerve block application
- Allergy to local anesthetics
- Pregnant or suspected pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Anesthesiology and Reanimation, University of Health Sciences, Diskapi Yıldırım Beyazit Training and Research Hospital
Ankara, 06450
About this study
Official title: Comparison of Perioperative Analgesic Effectiveness of Patients Who Had Fasia Iliac Compartment Block and 4in1 Block Applied in Total Knee Prosthesis Surgery
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- FICB, 4 in 1 block, Control
- Keywords
- FICB, 4 in 1 block, Total knee arthroplasty
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FICBOther
FICB is applied to the patients after spinal anesthesia.
4 in 1 blockOther
4 in 1 block is applied to the patients after spinal anesthesia.
ControlOther
Peripheral nerve block will not be performed on Group Control patients.
| Study group | Role | What they receive |
|---|---|---|
| Group Control | Other | Peripheral nerve block will not be performed on Group Control patients. Receives: Other: Control |
| Group FICB | Other | FICB will be performed with 30 ml %0.25 bupivacaine for Group FICB patients. Receives: Other: FICB |
| Group 4 IN 1 | Other | 4 in 1 block will be performed with 30 ml %0.25 bupivacaine for Group 4 IN 1 patients. Receives: Other: 4 in 1 block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total tramadol consumption in 24 hours (mg)
Total tramadol consumption used in the first 24 hours postoperatively
Measured: 24 hours postoperatively
Secondary outcomes (8)
Pain on the Numeric Rating Scale (NRS)
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
Measured: 0 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
Measured: 1 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
Measured: 4 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
Measured: 8 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
Measured: 12 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
NRS range was from 0-10 with being no pain and 10 the worst pain possible.
Measured: 24 hours postoperatively
Rescue Analgesic
Consumption of rescue analgesic used after 24 hours postoperatively.
Measured: 24 hours postoperatively
Patient satisfaction
The patient is satisfied or dissatisfied
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start30 May 2024
- Primary completion1 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Savas Altinsoy, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06436105
- Sponsor's protocol ID
- İsa Öteleş
- Status last verified
- Jun 2025
- First submitted
- 24 May 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29338141
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Analgesic Effectiveness of Patients Who Had Fasia Iliac Compartment Block and 4in1 Block Applied in Total Knee Prosthesis Surgery
- ClinicalTrials.gov ID
- NCT06436105
- Acronym / sponsor ID
- İsa Öteleş
- Conditions
- Pain, Postoperative
- Keywords
- FICB, 4 in 1 block, Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 30 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group Control | Other | Other: ControlPeripheral nerve block will not be performed on Group Control patients. |
| Group FICB | Other | Other: FICBFICB will be performed with 30 ml %0.25 bupivacaine for Group FICB patients. |
| Group 4 IN 1 | Other | Other: 4 in 1 block4 in 1 block will be performed with 30 ml %0.25 bupivacaine for Group 4 IN 1 patients. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- With informed consent
- Elective total knee arthroplasty with spinal anesthesia
- Oriented and cooperative
- ASA Classification I-II-III
- 18-85 years old
Key exclusion criteria (5 listed)
- Anticoagulant medication
- Coagulopathy
- Infection at the site of peripheral nerve block application
- Allergy to local anesthetics
- Pregnant or suspected pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FICBFICB is applied to the patients after spinal anesthesia. | Other | Group FICB |
| 4 in 1 block4 in 1 block is applied to the patients after spinal anesthesia. | Other | Group 4 IN 1 |
| ControlPeripheral nerve block will not be performed on Group Control patients. | Other | Group Control |
Primary outcome
Total tramadol consumption in 24 hours (mg)
Time frame: 24 hours postoperatively
Total tramadol consumption used in the first 24 hours postoperatively
8 secondary outcomes
Pain on the Numeric Rating Scale (NRS)
Time frame: 0 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 1 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 4 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 8 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 12 hours postoperatively
Pain on the Numeric Rating Scale (NRS)
Time frame: 24 hours postoperatively
Rescue Analgesic
Time frame: 24 hours postoperatively
Patient satisfaction
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- BackgroundRoy 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.
- Results publication: PubMed 29338141Kanadli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FICB and 4 in 1 block in people with Pain, Postoperative, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total tramadol consumption in 24 hours (mg) (time frame: 24 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06436105, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.