Total Knee Arthroplasty (Postoperative Pain)NCT07257757
Fascia Iliaca Compartment Block in Total Knee Arthroplasty With Intra-Articular Injection
An observational study of Total Knee Arthroplasty (Postoperative Pain), run by Kırıkkale University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of our study is to retrospectively investigate the effect of continuous fascia iliaca compartment block in total knee arthroplasty cases in addition to intraoperative intra-articular injection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty (Postoperative Pain)
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2024to 30 Jun 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent unilateral total knee arthroplasty at the Orthopedics and Traumatology Clinic of Kırıkkale University Faculty of Medicine Hospital and received postoperative analgesia using different methods
Who may be able to join
- Total knee arthroplasty cases with or without continuous fascia iliaca compartment block
- Patients with ASA criteria 1-2-3
Who cannot join
- Patients whose records cannot be accessed
- Patients with ASA criteria 4-5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Analgesic Efficacy of Fascia Iliaca Compartment Block in Patients Undergoing Total Knee Arthroplasty With Intra-Articular Injection: a Retrospective Cohort Study
The purpose of our study is to retrospectively investigate the effect of continuous fascia iliaca compartment block in total knee arthroplasty cases in addition to intraoperative intra-articular injection.
Read the detailed description
Postoperative pain management is of great importance in orthopedic surgeries. Inadequate analgesia following total knee arthroplasty increases the risk of side effects such as thromboembolism, myocardial ischemia, pulmonary dysfunction, paralytic ileus, urinary retention, and postoperative bleeding, thereby prolonging hospital stays.
Recently, fascia iliaca compartment block (FICB) has been frequently used to treat pain following knee replacement surgery. However, there are only a limited number of studies demonstrating the effectiveness of this method for postoperative analgesia. Sensory innervation of the lower extremity is primarily provided by four main nerves and their branches. These are the sciatic nerve, femoral nerve, obturator nerve, and lateral femoral cutaneous nerve. FICB is a compartment block in which local anesthetic is injected under the iliac fascia to block the femoral nerve, obturator nerve, and lateral femoral cutaneous nerve. The iliac fascia is the second fascial plane encountered when examining the proximal lower extremity with ultrasound (USG), extending immediately beneath the fascia latae. The goal is to place the needle tip under the iliac fascia, a few centimeters away from the femoral artery. Then, a single dose of local anesthetic can be administered under the iliac fascia, or a catheter can be placed in this area with ultrasound guidance.
Cocktails containing local anesthetic, narcotic analgesic, epinephrine, methylprednisolone, and cefuroxime are injected periarticularly for the preemptive treatment of pain following knee replacement surgery. This method, one of the multimodal protocols, is used to minimize the use of parenteral narcotics in order to protect against side effects.
Regional blocks are simple techniques that not only improve postoperative pain control but also reduce postoperative opioid requirements, shorten hospital stays, increase patient satisfaction, and lead to better clinical outcomes after total knee arthroplasty.
In our clinic, continuous fascia iliaca compartment block is applied for postoperative analgesia in total knee arthroplasty cases. The aim of this study is to retrospectively investigate the effect of continuous fascia iliaca compartment block in addition to intraoperative intra-articular injection on postoperative analgesia, postoperative bleeding and patient satisfaction in total knee arthroplasty cases.
- Keywords
- Postoperative, Patient Satisfaction, Pain, Bleeding, Peripheral Nerve Block, Continuous Fascia Iliaca Comparment Block, Intra-articular Injection
- Medical subject headings
- Pain, Postoperative, Patient Satisfaction, Pain, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Total knee arthroplasty cases where only intra-articular injection was performed | |
| Continuous Fascia Iliaca Compartment Block Group | Total knee arthroplasty cases in which continuous fascia iliaca compartment block is performed in addition to intra-articular injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
The visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: Postoperative 24 hours
Secondary outcomes (2)
Rating levels of satisfaction
A possible scale is then: "Not at all Satisfied," "Partly Satisfied," "Satisfied," "More than Satisfied," "Very Satisfied," numbering 1 to 5 as an interval scale.
Measured: Posoperative 24 hours
Recording of surgical drain output
Monitoring the output from surgical drains is important part of post-operative care. It is a measurement method that allows us to monitor the amount of bleeding in a patient after surgery.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start5 Jun 2024
- Primary completion15 Jan 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (Postoperative Pain)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kırıkkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Gün, Kırıkkale University
- Investigators
- Kevser PEKER, Assoc. Prof., Study director, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257757
- Sponsor's protocol ID
- KirikkaleU-2024.06.01
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Analgesic Efficacy of Fascia Iliaca Compartment Block in Patients Undergoing Total Knee Arthroplasty With Intra-Articular Injection: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07257757
- Acronym / sponsor ID
- KirikkaleU-2024.06.01
- Keywords
- Postoperative, Patient Satisfaction, Pain, Bleeding, Peripheral Nerve Block, Continuous Fascia Iliaca Comparment Block, Intra-articular Injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kırıkkale UniversityUniversity, hospital or other
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 2 Dec 2025 (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.
The purpose of our study is to retrospectively investigate the effect of continuous fascia iliaca compartment block in total knee arthroplasty cases in addition to intraoperative intra-articular injection.
Detailed description
Postoperative pain management is of great importance in orthopedic surgeries. Inadequate analgesia following total knee arthroplasty increases the risk of side effects such as thromboembolism, myocardial ischemia, pulmonary dysfunction, paralytic ileus, urinary retention, and postoperative bleeding, thereby prolonging hospital stays.
Recently, fascia iliaca compartment block (FICB) has been frequently used to treat pain following knee replacement surgery. However, there are only a limited number of studies demonstrating the effectiveness of this method for postoperative analgesia. Sensory innervation of the lower extremity is primarily provided by four main nerves and their branches. These are the sciatic nerve, femoral nerve, obturator nerve, and lateral femoral cutaneous nerve. FICB is a compartment block in which local anesthetic is injected under the iliac fascia to block the femoral nerve, obturator nerve, and lateral femoral cutaneous nerve. The iliac fascia is the second fascial plane encountered when examining the proximal lower extremity with ultrasound (USG), extending immediately beneath the fascia latae. The goal is to place the needle tip under the iliac fascia, a few centimeters away from the femoral artery. Then, a single dose of local anesthetic can be administered under the iliac fascia, or a catheter can be placed in this area with ultrasound guidance.
Cocktails containing local anesthetic, narcotic analgesic, epinephrine, methylprednisolone, and cefuroxime are injected periarticularly for the preemptive treatment of pain following knee replacement surgery. This method, one of the multimodal protocols, is used to minimize the use of parenteral narcotics in order to protect against side effects.
Regional blocks are simple techniques that not only improve postoperative pain control but also reduce postoperative opioid requirements, shorten hospital stays, increase patient satisfaction, and lead to better clinical outcomes after total knee arthroplasty.
In our clinic, continuous fascia iliaca compartment block is applied for postoperative analgesia in total knee arthroplasty cases. The aim of this study is to retrospectively investigate the effect of continuous fascia iliaca compartment block in addition to intraoperative intra-articular injection on postoperative analgesia, postoperative bleeding and patient satisfaction in total knee arthroplasty cases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | –Total knee arthroplasty cases where only intra-articular injection was performed |
| Continuous Fascia Iliaca Compartment Block Group | – | –Total knee arthroplasty cases in which continuous fascia iliaca compartment block is performed in addition to intra-articular injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent unilateral total knee arthroplasty at the Orthopedics and Traumatology Clinic of Kırıkkale University Faculty of Medicine Hospital and received postoperative analgesia using different methods
Key inclusion criteria (2 listed)
- Total knee arthroplasty cases with or without continuous fascia iliaca compartment block
- Patients with ASA criteria 1-2-3
Key exclusion criteria (2 listed)
- Patients whose records cannot be accessed
- Patients with ASA criteria 4-5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual Analog Scale
Time frame: Postoperative 24 hours
The visual analog scale is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
2 secondary outcomes
Rating levels of satisfaction
Time frame: Posoperative 24 hours
Recording of surgical drain output
Time frame: Postoperative 24 hours
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 2 Dec 2025.
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Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
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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.
Kevser PEKER, Assoc. Prof. study director
Kırıkkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty (Postoperative Pain), run by Kırıkkale University 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 2 inclusion and 2 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 2 Dec 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?
Visual Analog Scale (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2025.