AnalgesiaNCT05636449
Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty
A study testing Group Suprainguinal fascia iliaca block and Group Periarticular Infiltration in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints. Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Analgesia
- What is being tested?
- Group Suprainguinal fascia iliaca block and Group Periarticular Infiltration
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2022to 30 May 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-III patients
- Total knee arthroplasty
Who cannot join
- BMI>35
- liver, kidney, and advanced heart failure,
- routine use of analgesics and
- having used analgesics in the last 24 hours,
- having neuropathic pain,
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty: Prospective Randomized Study
Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints.
Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the advancement of surgical techniques and pharmacological treatments.
Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially in hip surgeries. In this way, the investigators think it can be used as a part of multimodal analgesia in total knee arthroplasty surgery.
- Conditions
- Analgesia
- Being tested
- Group Suprainguinal fascia iliaca block, Group Periarticular Infiltration
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Suprainguinal fascia iliaca blockOther
After the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle.
Group Periarticular InfiltrationOther
A total volume of 80 ml local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon.
| Study group | Role | What they receive |
|---|---|---|
| Group Suprainguinal fascia iliaca block | Active comparator | Suprainguinal fascia iliaca block after the surgery Receives: Other: Group Suprainguinal fascia iliaca block |
| Group Periarticular Infiltration Group | Active comparator | A local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon. Receives: Other: Group Periarticular Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Measured: first 24 hours
Secondary outcomes (5)
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (between 0-10; 0: no pain, 10:worst pain) score
Measured: first 48 hours
timed up and go test (TUG)
TUG- evaluation of the time in seconds for the patient to get up from the chair and walk 3 meters and return to the chair again
Measured: at 24th hour
quadriceps muscle strength
will be evaluated in a scale between 1-5 (1:lowest; 5:normal)
Measured: at 24th hour
joint range of motion test (ROM)
will be measured with goniometer( between 0-180 degrees)
Measured: at 24th hour
Five Time Sit to Stand Test (FTSST)
physical assistance of the patient getting up and sitting down 'as fast as possible' five times without
Measured: at 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start25 Nov 2022
- Primary completion15 May 2023
- Study completion30 May 2023
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 AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Oral Ahiskalioglu, Ataturk University
- Investigators
- Elif Oral Ahiskalioglu, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636449
- Sponsor's protocol ID
- ataunikneesurgery
- Status last verified
- Jun 2023
- First submitted
- 15 Nov 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Suarez JC, Al-Mansoori AA, Kanwar S, Semien GA, Villa JM, McNamara CA, Patel PD. Effectiveness of Novel Adjuncts in Pain Management Following Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2018 Jul;33(7S):S136-S141. doi: 10.1016/j.arth.2018.02.088. Epub 2018 Mar 12.
PubMed 29628196Bravo D, Layera S, Aliste J, Jara A, Fernandez D, Barrientos C, Wulf R, Munoz G, Finlayson RJ, Tran Q. Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial. J Clin Anesth. 2020 Nov;66:109907. doi: 10.1016/j.jclinane.2020.109907. Epub 2020 Jun 2.
PubMed 32502775
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Suprainguinal Fascia Iliaca Block vs. Periarticular Injection for Total Knee Arthroplasty: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05636449
- Acronym / sponsor ID
- ataunikneesurgery
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 5 Dec 2022 (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.
Total knee replacement (total knee arthroplasty) is performed to resurface a knee damaged by arthritis and relieve pain in patients with severely damaged knee joints.
Total knee arthroplasty (TKA) is associated with severe postoperative pain, and the management of postoperative pain continues to evolve with the advancement of surgical techniques and pharmacological treatments.
Femoral, lateral femoral cutaneous nerve and obturator nerve block is provided with suprainguinal fascia iliaca plan block, which is used for postoperative analgesia, especially in hip surgeries. In this way, the investigators think it can be used as a part of multimodal analgesia in total knee arthroplasty surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Suprainguinal fascia iliaca block | Active comparator | Other: Group Suprainguinal fascia iliaca blockSuprainguinal fascia iliaca block after the surgery |
| Group Periarticular Infiltration Group | Active comparator | Other: Group Periarticular InfiltrationA local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist's physiologic state I-III patients
- Total knee arthroplasty
Key exclusion criteria (6 listed)
- BMI>35
- liver, kidney, and advanced heart failure,
- routine use of analgesics and
- having used analgesics in the last 24 hours,
- having neuropathic pain,
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 |
|---|---|---|
| Group Suprainguinal fascia iliaca blockAfter the operation is completed, the fascia iliaca will be separated from the iliacus muscle. With ultrasound guidance, the local anesthetic injection will be made between the fascia and the muscle. | Other | Group Suprainguinal fascia iliaca block |
| Group Periarticular InfiltrationA total volume of 80 ml local anesthetic will be applied to the medial and lateral capsule, the medial and lateral meniscus margins, the deep part of the medial ligament, the medial and lateral synovial space, and the patellar ligament and quadriceps tendon. | Other | Group Periarticular Infiltration Group |
Primary outcome
Postoperative opioid consumption
Time frame: first 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
5 secondary outcomes
Visual analog pain score
Time frame: first 48 hours
timed up and go test (TUG)
Time frame: at 24th hour
quadriceps muscle strength
Time frame: at 24th hour
joint range of motion test (ROM)
Time frame: at 24th hour
Five Time Sit to Stand Test (FTSST)
Time frame: at 24th hour
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 18 Jun 2023.
- Background: PubMed 29628196Suarez JC, Al-Mansoori AA, Kanwar S, Semien GA, Villa JM, McNamara CA, Patel PD. Effectiveness of Novel Adjuncts in Pain Management Following Total Knee Arthroplasty: A Randomized Clinical Trial. J Arthroplasty. 2018 Jul;33(7S):S136-S141. doi: 10.1016/j.arth.2018.02.088. Epub 2018 Mar 12.
- Background: PubMed 32502775Bravo D, Layera S, Aliste J, Jara A, Fernandez D, Barrientos C, Wulf R, Munoz G, Finlayson RJ, Tran Q. Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial. J Clin Anesth. 2020 Nov;66:109907. doi: 10.1016/j.jclinane.2020.109907. Epub 2020 Jun 2.
- Individual participant dataSharing planned: Undecided
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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.
Elif Oral Ahiskalioglu study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Suprainguinal fascia iliaca block and Group Periarticular Infiltration in people with Analgesia, run by Ataturk 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 6 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 18 Jun 2023. 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?
Postoperative opioid consumption (time frame: first 24 hours). 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 NCT05636449, 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 18 Jun 2023.