Knee Arthroplasty, TotalNCT06357013
Postoperative Analgesia in Bilateral Knee Arthroplasties
An observational study of Knee Arthroplasty, Total and Peripheral Nerve Block, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty, Total, Peripheral Nerve Block, Pain, Postoperative
- What is being tested?
- Bilateral Suprainguinal fascia iliaca compartment block and Local infiltration analgesia
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Jun 2024
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged 18-75 years, who planned elective bilateral knee arthroplasty under spinal anesthesia, American Society of Anesthesiologists (ASA) risk score I-II.
Who may be able to join
- Planned elective bilateral knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) risk score I-II
- Patients aged 18-75 years
Who cannot join
- Those receiving general anesthesia,
- Those with epidural catheters,
- Those who refused to participate in the study,
- Those whose spinal anesthesia failed and returned to general anesthesia,
- Those with a body mass index (BMI) >30 kg/m2,
- History of chronic opioid or corticosteroid use,
- Patients with psychiatric or neurological problems that would not allow assessment of pain using a visual analog scale (VAS) will be excluded.
- In addition, patients whose surgery lasted <40 minutes or >120 minutes will also be excluded to keep the data homogeneous.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesia in Bilateral Knee Arthroplasties:Suprainguinal Fascia Iliaca Compartment Block and Local Infiltration Analgesia
To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period.
- Being tested
- Bilateral Suprainguinal fascia iliaca compartment block, Local infiltration analgesia
- Keywords
- pain, pain management, nerve block
- Medical subject headings
- Pain, Postoperative, Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Suprainguinal fascia iliaca compartment blockProcedure or surgery
Suprainguinal fascia iliaca compartment block (S-FICB) is one of the commonly used regional analgesia techniques for postoperative analgesia in lower extremity surgeries.
Local infiltration analgesiaProcedure or surgery
Local infiltration analgesia is applied to the posterior part of the knee, including the periosteum, ligaments, muscle and/or skin area before closing the surgical field.
| Study group | Role | What they receive |
|---|---|---|
| Grup-1: Suprainguinal fascia iliaca compartment block | Not described Receives: Procedure: Bilateral Suprainguinal fascia iliaca compartment block | |
| Grup-2: Local infiltration analgesia | Not described Receives: Procedure: Local infiltration analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty.
The aim of this study was to observationally compare the analgesic efficacy of local infiltration analgesia (LIA) and suprainguinal fascia iliaca compartment block (S-FICB) techniques in patients who underwent bilateral knee operations. Postoperative pain follow-up of the patients will be done by recording Visual analog scales (VAS) at 4, 8, 12 and 24 hours. Additional analgesic needs and unwanted side effects will also be recorded.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jan 2024
- Primary completion1 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Merve Yazici Kara, Kocaeli City Hospital
- Investigators
- Merve Yazici Kara, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357013
- Sponsor's protocol ID
- 2023-40
- Status last verified
- Jan 2025
- First submitted
- 14 Mar 2024
- Last updated
- 14 Jan 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Bilateral Knee Arthroplasties:Suprainguinal Fascia Iliaca Compartment Block and Local Infiltration Analgesia
- ClinicalTrials.gov ID
- NCT06357013
- Acronym / sponsor ID
- 2023-40
- Keywords
- pain, pain management, nerve block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Apr 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.
To observationally compare the analgesic efficacy of LIA and S-FICB techniques and to record the pain scores of patients who underwent bilateral knee operations in the postoperative period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Grup-1: Suprainguinal fascia iliaca compartment block | – | Procedure: Bilateral Suprainguinal fascia iliaca compartment block |
| Grup-2: Local infiltration analgesia | – | Procedure: Local infiltration analgesia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-75 years, who planned elective bilateral knee arthroplasty under spinal anesthesia, American Society of Anesthesiologists (ASA) risk score I-II.
Key inclusion criteria (3 listed)
- Planned elective bilateral knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) risk score I-II
- Patients aged 18-75 years
Key exclusion criteria (8 listed)
- Those receiving general anesthesia,
- Those with epidural catheters,
- Those who refused to participate in the study,
- Those whose spinal anesthesia failed and returned to general anesthesia,
- Those with a body mass index (BMI) >30 kg/m2,
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 |
|---|---|---|
| Bilateral Suprainguinal fascia iliaca compartment blockSuprainguinal fascia iliaca compartment block (S-FICB) is one of the commonly used regional analgesia techniques for postoperative analgesia in lower extremity surgeries. | Procedure or surgery | Grup-1: Suprainguinal fascia iliaca compartment block |
| Local infiltration analgesiaLocal infiltration analgesia is applied to the posterior part of the knee, including the periosteum, ligaments, muscle and/or skin area before closing the surgical field. | Procedure or surgery | Grup-2: Local infiltration analgesia |
Primary outcome
Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty.
Time frame: 4 months
The aim of this study was to observationally compare the analgesic efficacy of local infiltration analgesia (LIA) and suprainguinal fascia iliaca compartment block (S-FICB) techniques in patients who underwent bilateral knee operations. Postoperative pain follow-up of the patients will be done by recording Visual analog scales (VAS) at 4, 8, 12 and 24 hours. Additional analgesic needs and unwanted side effects will also be recorded.
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 14 Jan 2025.
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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.
Merve Yazici Kara, MD principal investigator
Kocaeli City Hospital
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 Knee Arthroplasty, Total and Peripheral Nerve Block, run by Kocaeli City 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 3 inclusion and 8 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 14 Jan 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?
Suprainguinal fascia iliaca compartment block (S-FICB) produces adequate analgesic effect in knee arthroplasty. (time frame: 4 months). 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 14 Jan 2025.