ArthroplastyNCT07739108
Suprainguinal Fascia Iliaca Block vs. Adductor Canal Block for Analgesia After Total Knee Arthroplasty
A study testing PCA in people with Arthroplasty and Knee Osteoarthritis, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
This study evaluates the analgesic efficacy and motor-sparing properties of ultrasound-guided Suprainguinal Fascia Iliaca Block (S-FIB) compared with Adductor Canal Block (ACB) in patients undergoing primary total knee arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 45 to 100 years
- Conditions the study is for
- Arthroplasty, Knee Osteoarthritis
- What is being tested?
- PCA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Aug 2026to 12 Sep 2027
- 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 45 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA Physical Status I, II, or III
- Scheduled for elective unilateral primary total knee arthroplasty
- Able to understand and operate the PCA device
- Written informed consent provided
Who cannot join
- Pre-existing lower-extremity neurological deficit or motor weakness (e.g., severe diabetic neuropathy)
- Chronic opioid use (>30 mg oral morphine equivalents/day for >3 months)
- Infection at the block site or systemic sepsis
- Coagulopathy or bleeding diathesis
- Allergy to local anesthetics or study medications
- Revision TKA or bilateral knee procedures
- Cognitive impairment or inability to perform mobility/pain assessments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparing Suprainguinal Fascia Iliaca Block Versus Adductor Canal Block for Postoperative Pain Control Following Total Knee Arthroplasty;A Prospective, Double-Blind Controlled Trial
This study evaluates the analgesic efficacy and motor-sparing properties of ultrasound-guided Suprainguinal Fascia Iliaca Block (S-FIB) compared with Adductor Canal Block (ACB) in patients undergoing primary total knee arthroplasty (TKA). The main hypothesis is that ACB better preserves quadriceps muscle strength, allowing earlier functional mobilization, while providing comparable (non-inferior) analgesia to S-FIB.
Read the detailed description
Total knee arthroplasty is associated with severe postoperative pain requiring effective multimodal analgesia, and regional nerve blocks are integral to Fast-Track / ERAS (Enhanced Recovery After Surgery ) protocols. The Suprainguinal Fascia Iliaca Block (S-FIB) targets the anterior branches of the lumbar plexus (femoral, lateral femoral cutaneous, and obturator nerves) from a single high-volume injection, but proximal femoral spread can produce quadriceps motor weakness. The Adductor Canal Block (ACB) predominantly blocks the saphenous nerve, sparing motor function at the potential expense of less comprehensive analgesia.
- Conditions
- Arthroplasty, Knee Osteoarthritis
- Being tested
- PCA
- Keywords
- Suprainguinal Fascia Iliaca Block, Adductor Canal Block, Ultrasound-Guided Nerve Block, Regional Anesthesia
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCADrug
All patients receive standardized spinal anesthesia and postoperative intravenous PCA tramadol within a standardized multimodal regimen.
| Study group | Role | What they receive |
|---|---|---|
| S-FIB | Active comparator | Active ultrasound-guided Suprainguinal Fascia Iliaca Block Receives: Drug: PCA |
| ACB | Active comparator | Active ultrasound-guided Adductor Canal Block Receives: Drug: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity (NRS)
Numerical Rating Scale (0-10) at rest and during active knee flexion (30°). Time Frame: Postoperative hours 2, 6, 12, 24, and 48.
Measured: Postoperative hours 24 hour
Secondary outcomes (4)
Quadriceps Muscle Strength
Active Straight Leg Raise (SLR) Angle Maximum hip flexion angle (degrees, 0-90°) achieved during an active straight leg raise in the supine position, measured with a digital clinometer/goniometer.
Measured: Postoperative hours 6 and 12.
Cumulative Opioid Consumption
Total IV tramadol delivered via PCA (patient controlled analgesia).
Measured: 24 and 48 hours postoperatively.
Time to First Mobilization
Hours from end of surgery to first assisted/unassisted ambulation
Measured: Up to 48 hours postoperatively.
Quality of Recovery (QoR-15)
Validated 15-item questionnaire (0-150; higher = better recovery).
Measured: Baseline (preoperative) and 24 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start12 Aug 2026 (estimated)
- Primary completion12 Aug 2027 (estimated)
- Study completion12 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, PhD.MD, Principal investigator, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07739108
- Sponsor's protocol ID
- TBEK 2026/05-20
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Suprainguinal Fascia Iliaca Block Versus Adductor Canal Block for Postoperative Pain Control Following Total Knee Arthroplasty;A Prospective, Double-Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT07739108
- Acronym / sponsor ID
- TBEK 2026/05-20
- Conditions
- Arthroplasty, Knee Osteoarthritis
- Keywords
- Suprainguinal Fascia Iliaca Block, Adductor Canal Block, Ultrasound-Guided Nerve Block, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 12 Aug 2026 (estimated)
- Primary completion
- 12 Aug 2027 (estimated)
- Study completion
- 12 Sep 2027 (estimated)
- First posted
- 31 Jul 2026 (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.
This study evaluates the analgesic efficacy and motor-sparing properties of ultrasound-guided Suprainguinal Fascia Iliaca Block (S-FIB) compared with Adductor Canal Block (ACB) in patients undergoing primary total knee arthroplasty (TKA). The main hypothesis is that ACB better preserves quadriceps muscle strength, allowing earlier functional mobilization, while providing comparable (non-inferior) analgesia to S-FIB.
Detailed description
Total knee arthroplasty is associated with severe postoperative pain requiring effective multimodal analgesia, and regional nerve blocks are integral to Fast-Track / ERAS (Enhanced Recovery After Surgery ) protocols. The Suprainguinal Fascia Iliaca Block (S-FIB) targets the anterior branches of the lumbar plexus (femoral, lateral femoral cutaneous, and obturator nerves) from a single high-volume injection, but proximal femoral spread can produce quadriceps motor weakness. The Adductor Canal Block (ACB) predominantly blocks the saphenous nerve, sparing motor function at the potential expense of less comprehensive analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-FIB | Active comparator | Drug: PCAActive ultrasound-guided Suprainguinal Fascia Iliaca Block |
| ACB | Active comparator | Drug: PCAActive ultrasound-guided Adductor Canal Block |
Who may qualify
- Ages
- 45 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA Physical Status I, II, or III
- Scheduled for elective unilateral primary total knee arthroplasty
- Able to understand and operate the PCA device
- Written informed consent provided
Key exclusion criteria (7 listed)
- Pre-existing lower-extremity neurological deficit or motor weakness (e.g., severe diabetic neuropathy)
- Chronic opioid use (>30 mg oral morphine equivalents/day for >3 months)
- Infection at the block site or systemic sepsis
- Coagulopathy or bleeding diathesis
- Allergy to local anesthetics or study medications
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 |
|---|---|---|
| PCAAll patients receive standardized spinal anesthesia and postoperative intravenous PCA tramadol within a standardized multimodal regimen. | Drug | ACB, S-FIB |
Primary outcome
Postoperative Pain Intensity (NRS)
Time frame: Postoperative hours 24 hour
Numerical Rating Scale (0-10) at rest and during active knee flexion (30°). Time Frame: Postoperative hours 2, 6, 12, 24, and 48.
4 secondary outcomes
Quadriceps Muscle Strength
Time frame: Postoperative hours 6 and 12.
Cumulative Opioid Consumption
Time frame: 24 and 48 hours postoperatively.
Time to First Mobilization
Time frame: Up to 48 hours postoperatively.
Quality of Recovery (QoR-15)
Time frame: Baseline (preoperative) and 24 hours postoperatively.
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 3 Aug 2026.
- 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.
Korgün Ökmen, PhD.MD principal investigator
University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Department of Anesthesiology and Reanimation
Questions about this trial
What is this clinical trial studying?
A study testing PCA in people with Arthroplasty and Knee Osteoarthritis, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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 7 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Korgün Ökmen (+905057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (NRS) (time frame: Postoperative hours 24 hour). 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 3 Aug 2026.