AnalgesiaNCT06386575
Suprainguinal Fascia Iliaca Block in Knee Arthroplasty
A study testing suprainguinal fascia block; Patients receiving local anesthetic in people with Analgesia and Anesthesia, Local, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Anesthesia, Local
- What is being tested?
- suprainguinal fascia block; Patients receiving local anesthetic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2024to 3 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who will undergo unilateral total knee arthroplasty
- Patients who will undergo spinal anesthesia
- Patients aged 18-65 years, ASA I-III
- Patients who will stay in the hospital for at least 24 hours
Who cannot join
- Patients who do not want to give consent
- Patients who do not want spinal anesthesia
- Patients for whom regional anesthesia is contraindicated
- Patients with confusion
- Patients with coagulopathy
- Patients using anticoagulants
Show all 9Show fewer
- Patients with infection in the area to be treated
- Those who are allergic to local anesthesia
- Emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Supra-inguinal Fascia Iliaca Block on Recovery and Recovery Quality After Total Knee Arthroplasty: A Multicenter, Prospective Randomized Controlled, Double-blind Study.
Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.
Read the detailed description
Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.
The primary purpose of this study is; To evaluate the effects of suprainguinal fascia iliaca block on recovery and recovery in the postoperative period in patients who will undergo total knee arthroplasty surgery, using the quality of recovery-15T score.
Secondary purpose; Postoperative rest and movement numeric rating scale, patient likert scale, first rescue analgesia duration, number of patients needing rescue analgesia, total amount of rescue analgesic consumed, complications such as nausea and vomiting, and antiemetic requirements in patients who will undergo total knee arthroplasty surgery with suprainguinal fascia iliaca block is to evaluate.
- Conditions
- Analgesia, Anesthesia, Local
- Being tested
- control group; Patients who received physiological saline, suprainguinal fascia block; Patients receiving local anesthetic
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control group; Patients who received physiological salineOther
All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the control group will be given 40 milliliters of physiological saline during the suprainguinal fascia iliaca block.
suprainguinal fascia block; Patients receiving local anestheticOther
All patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the sfıb group will be given 40 milliliters of 0.25 % bupivacaine during the suprainguinal fascia iliaca block.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Not described Receives: Other: control group; Patients who received physiological saline |
| suprainguinal fascia iliaca block | Active comparator | Not described Receives: Other: suprainguinal fascia block; Patients receiving local anesthetic |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of recovery-15T
Quality of recovery-15T scores, which show the quality of recovery of the patients, will be recorded at the 24th hour after the surgery. Quality of recovery-15T (0-150, 0= lowest degree of satisfaction, 150= highest degree of satisfaction).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start6 Jun 2024
- Primary completion1 Aug 2024
- Study completion3 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Model description
- Suprainguinal fascia iliaca block will be applied to the patients at the end of the surgery.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Halit Satici, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386575
- Sponsor's protocol ID
- suprainguinal
- Status last verified
- Aug 2024
- First submitted
- 15 Apr 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Supra-inguinal Fascia Iliaca Block on Recovery and Recovery Quality After Total Knee Arthroplasty: A Multicenter, Prospective Randomized Controlled, Double-blind Study.
- ClinicalTrials.gov ID
- NCT06386575
- Acronym / sponsor ID
- suprainguinal
- Conditions
- Analgesia, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 3 Aug 2024 (actual)
- First posted
- 26 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.
Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.
Detailed description
Total knee arthroplasty is the most commonly performed orthopedic surgery, especially in patients with advanced gonarthrosis and limited joint movement. After total knee arthroplasty, patients experience unbearably severe pain. Pain that is not adequately treated in the postoperative period increases the stress response in patients, increases the risk of embolism, causes bleeding in the surgical area, and causes undesirable conditions such as agitation and delirium in patients. This postoperative pain is successfully treated with various variants of multimodal analgesia.
The primary purpose of this study is; To evaluate the effects of suprainguinal fascia iliaca block on recovery and recovery in the postoperative period in patients who will undergo total knee arthroplasty surgery, using the quality of recovery-15T score.
Secondary purpose; Postoperative rest and movement numeric rating scale, patient likert scale, first rescue analgesia duration, number of patients needing rescue analgesia, total amount of rescue analgesic consumed, complications such as nausea and vomiting, and antiemetic requirements in patients who will undergo total knee arthroplasty surgery with suprainguinal fascia iliaca block is to evaluate.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Suprainguinal fascia iliaca block will be applied to the patients at the end of the surgery.
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: control group; Patients who received physiological saline |
| suprainguinal fascia iliaca block | Active comparator | Other: suprainguinal fascia block; Patients receiving local anesthetic |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who will undergo unilateral total knee arthroplasty
- Patients who will undergo spinal anesthesia
- Patients aged 18-65 years, ASA I-III
- Patients who will stay in the hospital for at least 24 hours
Key exclusion criteria (9 listed)
- Patients who do not want to give consent
- Patients who do not want spinal anesthesia
- Patients for whom regional anesthesia is contraindicated
- Patients with confusion
- Patients with coagulopathy
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 |
|---|---|---|
| control group; Patients who received physiological salineAll patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the control group will be given 40 milliliters of physiological saline during the suprainguinal fascia iliaca block. | Other | control group |
| suprainguinal fascia block; Patients receiving local anestheticAll patients will be given 1 gram of paracetamol intravenously + 20 milligrams of tenoxicam + 8 milligrams of decort intravenously. Paracetamol 3x1 gram + tenoxicam 2x20 milligrams will continue to be administered. Patients in the sfıb group will be given 40 milliliters of 0.25 % bupivacaine during the suprainguinal fascia iliaca block. | Other | suprainguinal fascia iliaca block |
Primary outcome
quality of recovery-15T
Time frame: One day
Quality of recovery-15T scores, which show the quality of recovery of the patients, will be recorded at the 24th hour after the surgery. Quality of recovery-15T (0-150, 0= lowest degree of satisfaction, 150= highest degree of satisfaction).
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 6 Aug 2024.
- 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 suprainguinal fascia block; Patients receiving local anesthetic in people with Analgesia and Anesthesia, Local, run by Konya 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 4 inclusion and 9 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 6 Aug 2024. 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?
quality of recovery-15T (time frame: One day). 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 6 Aug 2024.