Total Knee ArthroplastyNCT07092982
Comparison of Two Different Regional Anesthetic Methods in Total Knee Arthroplasty Patients
A study testing Ultrasound Guided Suprainguinal Fascia Iliaca Block, Ultrasound Guided Adductor Canal Block and Ultrasound Guided iPACK Block in people with Total Knee Arthroplasty and Ultrasound Guided Supra-inguinal Fascia Iliaca Block, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Adductor Canal Block
- What is being tested?
- Ultrasound Guided Suprainguinal Fascia Iliaca Block, Ultrasound Guided Adductor Canal Block and Ultrasound Guided iPACK Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Aug 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee arthroplasty
- Patients aged 18-75
- Patients with ASA I-II-III
Who cannot join
- Coagulation disorders
- Allergy to local anesthetics
- Liver and renal failure
- Alcohol and drug addiction
- Cognitive dysfunction that may prevent pain assessment
- Systemic or needle insertion site infection
Show all 11Show fewer
- Analgesic use for more than 3 months
- Patient refusal to participate in the study/refusal to consent
- Presence of a hematoma, hernia, neoplasm, etc. in the area where the block will be performed
- Pre-existing neurological deficit
- Patients with contraindications to nerve block
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
SB Istanbul Education and Research Hospital
Istanbul
Kubilay Ekinci, MD, 0905062671972, kubilay.ekinci@sbu.edu.tr
About this study
Official title: Comparison of the Effects of Ultrasound-Guided Adductor Canal Block With iPACK (Space Between the Popliteal Artery and the Posterior Knee Capsule) Block Combination and Suprainguinal Fascia Iliaca Block on Postoperative Pain and Stress Response in Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. This can result in delayed physical therapy, prolonged hospital stays, the development of nosocomial infections, and impaired cognitive function. All of these factors contribute to increased patient care costs. Multimodal analgesia methods are used to control this pain. One of these methods is peripheral nerve blocks. Peripheral nerve blocks provide pain control and reduce the likelihood of opioid use and related side effects such as nausea, vomiting, and constipation. Current studies recommend Adductor Canal Blocks and iPACK (space between the popliteal artery and the posterior knee capsule) blocks for Total Knee Arthroplasty patients. In addition, studies are also being conducted on the application of the Suprainguinal Fascia-Iliaca Block in Total Knee Arthroplasty patients. The differences in postoperative analgesic effects between these methods are a matter of interest. No study has been conducted comparing the effects of these two approaches, which are routinely applied in our clinic and comply with guidelines, on the postoperative stress response. Regional anesthesia provides adequate pain control and has a positive effect on the stress response. The investigators aim to see a similar effect in peripheral nerve blocks. Therefore, comparing the methods that mentioned will contribute to the literature. In this study, the effects of these two different approaches on postoperative stress response and analgesic efficacy will be compared in terms of patients' postoperative opioid consumption, pain at rest and with movement, time to first analgesic need and development of motor block. IL-6 and CRP values will be examined pre-operatively and post-operatively to measure the effects on the stress response.
- Conditions
- Total Knee Arthroplasty, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Adductor Canal Block
- Being tested
- Ultrasound Guided Suprainguinal Fascia Iliaca Block, Ultrasound Guided Adductor Canal Block, Ultrasound Guided iPACK Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Suprainguinal Fascia Iliaca BlockProcedure or surgery
Ultrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25
Ultrasound Guided Adductor Canal BlockProcedure or surgery
Ultrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25
Ultrasound Guided iPACK BlockProcedure or surgery
Ultrasound Guided iPACK Block, 15ml Bupivacain %0,25
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided Fascia Iliaca Block | Active comparator | Suprainguinal fascia iliaca block was applied to the patients in this group at the end of the operation. Receives: Procedure: Ultrasound Guided Suprainguinal Fascia Iliaca Block |
| Ultrasound Guided Adductor Canal Block + iPACK Block | Active comparator | Adductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation. Receives: Procedure: Ultrasound Guided Adductor Canal Block; Procedure: Ultrasound Guided iPACK Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption
Tramadol consumption will be recorded for 24 hours.
Measured: 24 hours
Secondary outcomes (6)
Numeric rating scale for pain
Variations in the Numeric Rating Scale (NRS) scores, both at rest and during movement, will be documented at specific time points (End of the surgery, Post-operative 6th, 12th and 24th hour). The NRS is a simple, single-dimensional tool used to assess pain intensity in adult patients. It is a numeric adaptation of the Visual Analog Scale (VAS), where individuals are asked to choose an integer between 0 and 10 that best represents their pain level. A score of '0' corresponds to "no pain," while '10' indicates the "worst imaginable pain" or "pain as severe as possible.
Measured: Up to 24 hours
Time to first postoperative analgesic requirement
The time to first postoperative analgesic requirement was recorded.
Measured: Up to 24 hours
Postoperative quadriceps muscle strength
Muscle strength assessment will be performed using the Modified Bromage Scale. (End of the surgery, Post-operative 6th, 12th and 24th hour) Grade 0: No motor block; the patient is able to fully flex the hip and knee. Grade 1: Partial motor block; the patient is able to move the knee and foot but is unable to lift the extended leg.
Grade 2: Nearly complete motor block; the patient is unable to flex the knee and can only move the foot.
Grade 3: Complete motor block; the patient is unable to move the ankle or the great toe.
Measured: Up to 24 hours
Incidence of postoperative nausea and vomiting
Opioid side effects were recorded.
Measured: Up to 24 hours
Quality of Recovery 15 (QoR-15)
The influence of surgical and anesthetic interventions on perioperative quality of life and the patient's ability to return to routine daily activities will be systematically evaluated.
QoR-15 has 15 questions. Each question is answered on a scale of 1 to 10. A higher score indicates more positive outcomes.
Measured: 24 hours
Inflammatory marker levels
The levels of inflammatory biomarkers (interleukin-6, CRP, NLR [Neutrophil-Lymphocyte Ratio], PLR [Platelet-Lymphocyte Ratio]) will be assessed prior to surgery and at 24 hours postoperatively.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start4 Aug 2025
- Primary completion1 Jul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kubilay Ekinci, SB Istanbul Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092982
- Sponsor's protocol ID
- 56
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Ultrasound-Guided Adductor Canal Block With iPACK (Space Between the Popliteal Artery and the Posterior Knee Capsule) Block Combination and Suprainguinal Fascia Iliaca Block on Postoperative Pain and Stress Response in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07092982
- Acronym / sponsor ID
- 56
- Conditions
- Total Knee Arthroplasty, Ultrasound Guided Supra-inguinal Fascia Iliaca Block, Adductor Canal Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Jul 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.
Total Knee Arthroplasty patients are among the orthopedic cases that experience severe postoperative pain. In these cases, pain must be controlled. If pain is not controlled, early mobilization cannot be achieved. This can result in delayed physical therapy, prolonged hospital stays, the development of nosocomial infections, and impaired cognitive function. All of these factors contribute to increased patient care costs. Multimodal analgesia methods are used to control this pain. One of these methods is peripheral nerve blocks. Peripheral nerve blocks provide pain control and reduce the likelihood of opioid use and related side effects such as nausea, vomiting, and constipation. Current studies recommend Adductor Canal Blocks and iPACK (space between the popliteal artery and the posterior knee capsule) blocks for Total Knee Arthroplasty patients. In addition, studies are also being conducted on the application of the Suprainguinal Fascia-Iliaca Block in Total Knee Arthroplasty patients. The differences in postoperative analgesic effects between these methods are a matter of interest. No study has been conducted comparing the effects of these two approaches, which are routinely applied in our clinic and comply with guidelines, on the postoperative stress response. Regional anesthesia provides adequate pain control and has a positive effect on the stress response. The investigators aim to see a similar effect in peripheral nerve blocks. Therefore, comparing the methods that mentioned will contribute to the literature. In this study, the effects of these two different approaches on postoperative stress response and analgesic efficacy will be compared in terms of patients' postoperative opioid consumption, pain at rest and with movement, time to first analgesic need and development of motor block. IL-6 and CRP values will be examined pre-operatively and post-operatively to measure the effects on the stress response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided Fascia Iliaca Block | Active comparator | Procedure: Ultrasound Guided Suprainguinal Fascia Iliaca BlockSuprainguinal fascia iliaca block was applied to the patients in this group at the end of the operation. |
| Ultrasound Guided Adductor Canal Block + iPACK Block | Active comparator | Procedure: Ultrasound Guided Adductor Canal Block, Procedure: Ultrasound Guided iPACK BlockAdductor Canal Block and iPACK Block was applied to the patients in this group at the end of the operation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing total knee arthroplasty
- Patients aged 18-75
- Patients with ASA I-II-III
Key exclusion criteria (11 listed)
- Coagulation disorders
- Allergy to local anesthetics
- Liver and renal failure
- Alcohol and drug addiction
- Cognitive dysfunction that may prevent pain assessment
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 |
|---|---|---|
| Ultrasound Guided Suprainguinal Fascia Iliaca BlockUltrasound Guided Suprainguinal Fascia Iliaca Block, 30 ml Bupivacain %0,25 | Procedure or surgery | Ultrasound Guided Fascia Iliaca Block |
| Ultrasound Guided Adductor Canal BlockUltrasound Guided Adductor Canal Block, 15ml Bupivacain %0,25 | Procedure or surgery | Ultrasound Guided Adductor Canal Block + iPACK Block |
| Ultrasound Guided iPACK BlockUltrasound Guided iPACK Block, 15ml Bupivacain %0,25 | Procedure or surgery | Ultrasound Guided Adductor Canal Block + iPACK Block |
Primary outcome
Cumulative opioid consumption
Time frame: 24 hours
Tramadol consumption will be recorded for 24 hours.
6 secondary outcomes
Numeric rating scale for pain
Time frame: Up to 24 hours
Time to first postoperative analgesic requirement
Time frame: Up to 24 hours
Postoperative quadriceps muscle strength
Time frame: Up to 24 hours
Incidence of postoperative nausea and vomiting
Time frame: Up to 24 hours
Quality of Recovery 15 (QoR-15)
Time frame: 24 hours
Inflammatory marker levels
Time frame: Up to 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Suprainguinal Fascia Iliaca Block, Ultrasound Guided Adductor Canal Block and Ultrasound Guided iPACK Block in people with Total Knee Arthroplasty and Ultrasound Guided Supra-inguinal Fascia Iliaca Block, run by SB Istanbul 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 3 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubilay Ekinci, MD (0905062671972, kubilay.ekinci@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative opioid consumption (time frame: 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 6 Apr 2026.