Osteo Arthritis of the KneeNCT07130552
Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty
A study testing femoral triangle block and popliteal plexus block and Femoral triangle block and distal iPACK in people with Osteo Arthritis of the Knee, run by Karaman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the effect of femoral triangle block combined with popliteal plexus block and distal IPACK block on postoperative pain after total knee arthroplasty (TKA) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- femoral triangle block and popliteal plexus block and Femoral triangle block and distal iPACK
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Dec 2025to 30 Dec 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing total knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) status I-III
- Patients who give informed consent
Who cannot join
- Patients unable to cooperate
- Kidney disease with GFR < 50 ml/min
- Daily opioid consumption > 1 month
- Allergy to local anesthetics
- Neurological problems of the lower extremity
- Contraindications to peripheral nerve blocks
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
Karaman Training and Research Hospital, Karaman, Karaman 70200
Karaman, 70200
Tayfun Et, 05063670717, drtayfunet@gmail.com
About this study
This study aims to investigate the effect of femoral triangle block combined with popliteal plexus block and distal IPACK block on postoperative pain after total knee arthroplasty (TKA)
Read the detailed description
Popliteal Plexus Block (PPB) is a new nerve block technique that has been shown to anaesthetise nerves involved in the innervation of the posterior part of the knee joint.
The IPACK (interspace between the popliteal artery and capsule of the posterior knee) block is a regional anesthesia technique in which a local anesthetic is infiltrated under ultrasound guidance between the popliteal artery and the capsule of the posterior knee. This technique blocks the branches of the obturator nerve, the common peroneal nerve, and the tibial nerve in the popliteal region. In the context of knee arthroplasty, the application of the IPACK block has been associated with lower scores for ambulatory pain, lower scores for resting pain, and reduced morphine consumption.
Although both techniques of blockade seem to be efficient in the context of analgesia for the posterior part of the knee after TKA. No study compares these two blocks as part of multimodal analgesia to provide pain relief after TKA.
This study aimed to evaluate the analgesic effect of PPB or distal IPACK, in addition to femoral triangle block, as a component of a multimodal analgesic regimen after TKA.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- femoral triangle block and popliteal plexus block, Femoral triangle block and distal iPACK
- Keywords
- Total knee arthroplasty, popliteal plexus block, femoral triangle block, iPACK block (infiltration of the interspace between the popliteal artery and the posterior knee capsule)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femoral triangle block and popliteal plexus blockDevice
Single dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for PPB
Femoral triangle block and distal iPACKDevice
Single dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for distal iPACK
| Study group | Role | What they receive |
|---|---|---|
| Group Popliteal plexus block | Experimental | femoral triangle block and popliteal plexus block Receives: Device: femoral triangle block and popliteal plexus block |
| Group distal iPACK | Experimental | Femoral triangle block and distal iPACK Receives: Device: Femoral triangle block and distal iPACK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
Total opioid consumption in each group, A, B until 24 hours postoperative.
Measured: 24 hours
Secondary outcomes (11)
NRS scores
Numerical Rating Scale (NRS) scores (Range 0-10, 0=no pain, 10=the worse pain ever)
Measured: 48 hours
Range of knee motion
Degrees of flexion
Measured: 48 hours
Patient mobilization
Patient reporting time of first standing to the side of the bed and time up and go test 2 days
Measured: 48 hours
Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value
Both MVIC test are assessed preoperative, using a handheld dynamometer
Measured: A 60-minute interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value
Both MVIC tests are assessed preoperative, using a handheld dynamometer
Measured: A 60-minute interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value
Both MVIC tests are assessed preoperative, using a handheld dynamometer
Measured: A 60 minutes interval is between pre-block and post-block MVIC assessments
Muscle strength of knee extension, graded by Manual Muscle Test (MMT)
Grade 3: Able to extend the knee in active Range of Motion (ROM) against gravity, Grade 2: Patient is lying on the side, with knee resting on the bed, able to extend the knee in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the quadriceps muscle is palpable or observable but the knee does not extend, Grade 0: No muscle contraction of the quadriceps muscle is palpable or observable
Measured: Assessed pre-block, post-block (60 minutes after pre-block), and postoperative 5 hours
Muscle strength of ankle plantarflexion, graded by MMT
Grade 3: Able to plantarflex in active ROM, Grade 2: Patient is lying on the side, with ankle resting on the bed, able to plantarflex the ankle in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the gastrocnemius muscle is palpable or observable but the ankle does not plantarflex, Grade 0: No muscle contraction of the gastrocnemius muscle is palpable or observable
Measured: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours
Muscle strength of ankle dorsiflexion, graded by MMT
Grade 3: Able to dorsiflex in active ROM Grade 2: Patient is lying on the side, with ankle resting on the bed, able to dorsiflex the ankle in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the tibialis anterior muscle is palpable or observable but the ankle does not dorsiflex, Grade 0: No muscle contraction of the tibialis anterior muscle is palpable or observable
Measured: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours
Incidence of rebound pain
Rebound pain is described as severe pain (NRS ≥ 7)
Measured: Postoperative 24 hours
Quality of Recovery 15 Score
Quality of Recovery (QoR)-15 survey.Minimum value: 0, Maximum value: 150, higher scores mean better.
Measured: Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start29 Dec 2025
- Primary completion25 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis of the KneeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karaman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130552
- Sponsor's protocol ID
- 06-2022/16
- Status last verified
- Sep 2026
- First submitted
- 12 Aug 2025
- Last updated
- 22 Sep 2026
- 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 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07130552
- Acronym / sponsor ID
- 06-2022/16
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- Total knee arthroplasty, popliteal plexus block, femoral triangle block, iPACK block (infiltration of the interspace between the popliteal artery and the posterior knee capsule)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karaman Training and Research HospitalUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Aug 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.
This study aims to investigate the effect of femoral triangle block combined with popliteal plexus block and distal IPACK block on postoperative pain after total knee arthroplasty (TKA)
Detailed description
Popliteal Plexus Block (PPB) is a new nerve block technique that has been shown to anaesthetise nerves involved in the innervation of the posterior part of the knee joint.
The IPACK (interspace between the popliteal artery and capsule of the posterior knee) block is a regional anesthesia technique in which a local anesthetic is infiltrated under ultrasound guidance between the popliteal artery and the capsule of the posterior knee. This technique blocks the branches of the obturator nerve, the common peroneal nerve, and the tibial nerve in the popliteal region. In the context of knee arthroplasty, the application of the IPACK block has been associated with lower scores for ambulatory pain, lower scores for resting pain, and reduced morphine consumption.
Although both techniques of blockade seem to be efficient in the context of analgesia for the posterior part of the knee after TKA. No study compares these two blocks as part of multimodal analgesia to provide pain relief after TKA.
This study aimed to evaluate the analgesic effect of PPB or distal IPACK, in addition to femoral triangle block, as a component of a multimodal analgesic regimen after TKA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Popliteal plexus block | Experimental | Device: femoral triangle block and popliteal plexus blockfemoral triangle block and popliteal plexus block |
| Group distal iPACK | Experimental | Device: Femoral triangle block and distal iPACKFemoral triangle block and distal iPACK |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing total knee arthroplasty under spinal anesthesia
- American Society of Anesthesiologists (ASA) status I-III
- Patients who give informed consent
Key exclusion criteria (6 listed)
- Patients unable to cooperate
- Kidney disease with GFR < 50 ml/min
- Daily opioid consumption > 1 month
- Allergy to local anesthetics
- Neurological problems of the lower extremity
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 |
|---|---|---|
| femoral triangle block and popliteal plexus blockSingle dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for PPB | Device | Group Popliteal plexus block |
| Femoral triangle block and distal iPACKSingle dose bolus, 10 ml 5% bupivacaine will be used for FTB, 10 ml 5% bupivacaine will be used for distal iPACK | Device | Group distal iPACK |
Primary outcome
Opioid consumption
Time frame: 24 hours
Total opioid consumption in each group, A, B until 24 hours postoperative.
11 secondary outcomes
NRS scores
Time frame: 48 hours
Range of knee motion
Time frame: 48 hours
Patient mobilization
Time frame: 48 hours
Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value
Time frame: A 60-minute interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value
Time frame: A 60-minute interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value
Time frame: A 60 minutes interval is between pre-block and post-block MVIC assessments
Muscle strength of knee extension, graded by Manual Muscle Test (MMT)
Time frame: Assessed pre-block, post-block (60 minutes after pre-block), and postoperative 5 hours
Muscle strength of ankle plantarflexion, graded by MMT
Time frame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours
Muscle strength of ankle dorsiflexion, graded by MMT
Time frame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours
Incidence of rebound pain
Time frame: Postoperative 24 hours
Quality of Recovery 15 Score
Time frame: Postoperative Day 1
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 22 Sep 2026.
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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 femoral triangle block and popliteal plexus block and Femoral triangle block and distal iPACK in people with Osteo Arthritis of the Knee, run by Karaman Training 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 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: looking for participants now, as of the sponsor's last update on 22 Sep 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 Tayfun Et (+905063670717, drtayfunet@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 22 Sep 2026.