Pain, PostoperativeNCT07267650
iPACK Block vs. Periarticular Infiltration for TKA Pain Control
An observational study of Pain, Postoperative and Osteoarthritis, Knee / Osteoarthritis, Hip, run by Turgutlu State Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to retrospectively compare two different multimodal analgesic techniques for pain management after total knee arthroplasty (TKA). The primary purpose is to evaluate whether a combination of two specific nerve blocks administered by an anesthesiologist (Femoral Triangle Block + iPACK block) resulted in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Osteoarthritis, Knee / Osteoarthritis, Hip
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 1 Aug 2026
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients who underwent elective, primary, unilateral total knee arthroplasty (TKA) under spinal anesthesia at Turgutlu State Hospital. Patient records and institutional registries will be reviewed retrospectively to identify eligible cases managed within a specific operational period (e.g., between December 2025 and May 2026). The cohort includes patients who received either an ultrasound-guided Femoral Triangle Block combined with an iPACK block or a hybrid combination of Femoral Triangle Block and surgeon-administered Periarticular Infiltration for postoperative analgesia as part of standard clinical care.
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status II-III.
- Scheduled for elective, primary, unilateral total knee arthroplasty for osteoarthritis.
- Able to provide written informed consent.
Who cannot join
- Patient refusal to participate or contraindication to regional anesthesia.
- Known allergy to any study medications (local anesthetics, NSAIDs, tramadol, morphine, paracetamol).
- History of chronic opioid use (defined as daily use for >3 months)
- Pre-existing peripheral neuropathy in the operative limb.
- Severe renal or hepatic insufficiency.
- Cognitive impairment preventing the use of pain scales or questionnaires.
- Revision or bilateral knee arthroplasty.
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
Turgutlu State Hospital+
Manisa, Manisa, 45000
About this study
Official title: Postoperative Analgesic Outcomes of iPACK Block Versus Periarticular Infiltration in Total Knee Arthroplasty: A Retrospective Cohort Study
This study aims to retrospectively compare two different multimodal analgesic techniques for pain management after total knee arthroplasty (TKA). The primary purpose is to evaluate whether a combination of two specific nerve blocks administered by an anesthesiologist (Femoral Triangle Block + iPACK block) resulted in superior postoperative pain control compared to a hybrid combination of a nerve block and a local infiltration administered by the surgeon (FTB + Periarticular Infiltration [PAI]).
The hypothesis is that the FTB + iPACK combination is associated with a significant reduction in Numeric Rating Scale (NRS) pain scores with movement at 24 hours postoperatively. This is a retrospective, observational cohort study conducted at a single center, involving medical records of patients who underwent primary unilateral TKA. Data from patients who received either FTB + iPACK or FTB + PAI as part of their standard clinical care will be extracted and analyzed retrospectively.
Read the detailed description
Total knee arthroplasty (TKA) is a highly successful procedure for end-stage knee osteoarthritis but is associated with significant postoperative pain. Effective pain management is crucial for facilitating early rehabilitation and improving patient comfort. Modern pain management relies on multimodal, opioid-sparing protocols that often include motor-sparing regional anesthesia techniques like the femoral triangle block (FTB).
While FTB provides excellent analgesia for the anterior part of the knee, pain originating from the posterior knee capsule remains a significant challenge. This posterior pain is commonly managed either by the surgeon through a diffuse periarticular infiltration (PAI) of a local anesthetic cocktail or by the anesthesiologist through a targeted, ultrasound-guided block of the posterior capsule known as the iPACK block.
It is currently unclear whether a fully anesthesiologist-driven, neuroanatomically targeted approach (FTB + iPACK) offers superior clinical outcomes compared to a hybrid approach involving both the anesthesiologist and the surgeon (FTB + PAI). This retrospective study is designed to compare the clinical efficacy of these two advanced analgesic combinations by reviewing institutional patient registries. All included patients had previously received a standardized spinal anesthetic (3 mL of 0.5% heavy bupivacaine) followed by either of the regional analgesia protocols. The study evaluates postoperative pain control, measured primarily by Numeric Rating Scale (NRS) pain scores at 24 hours. Secondary outcomes include total rescue analgesic (tramadol) consumption, functional recovery (Timed Up and Go test and Straight Leg Raise test), and knee range of motion.
- Keywords
- Total Knee Arthroplasty, TKA, Postoperative Pain, Pain Management, Analgesia, Nerve Block, Femoral Triangle Block, FTB, iPACK block, Local Infiltration Analgesia, Timed Up and Go Test, Straight Leg Raise, Periarticular Infiltration, Regional Anesthesia
- Medical subject headings
- Pain, Postoperative, Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| FTB + iPACK Group | Patients who underwent primary unilateral TKA and received FTB + iPACK block as part of standard clinical care. | |
| FTB + PAI Group | Patients who underwent primary unilateral TKA and received FTB + PAI as part of standard clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score with Movement at 24 Hours
Pain assessed via Numeric Rating Scale (NRS) during active movement (e.g., active knee flexion or straight leg raise). Scale: 0 (no pain) to 10 (worst pain imaginable).
Measured: 24 and 48. hours postoperatively
Secondary outcomes (6)
Postoperative Pain Scores (Time-Course)
Numeric Rating Scale (NRS) for pain (0-10) assessed at rest and with movement.
Measured: Assessed at 6, 12, and 24 hours postoperatively
Time to First Rescue Analgesia
Time (in minutes) from the end of surgery to the first patient request for rescue tramadol.
Measured: First 24 postoperative hours
Time Up to Go Test
The time taken (in seconds) for the participant to stand up from a standard armchair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Lower values indicate better functional mobility.
Measured: Assessed at 24 hours
Straight Leg Raise
Assessment of active quadriceps motor function. Defined as the participant's ability to actively lift the operated leg off the bed with the knee fully extended (straight). This will be assessed as a binary outcome (Success = Able to lift unassisted / Failure = Unable to lift).
Measured: Postoperative 24. hour
Knee Range of Motion (ROM)
Active knee flexion (in degrees)
Measured: Baseline (Preoperative) and 24 hours postoperatively
Incidence of Adverse Events
Incidence of postoperative nausea/vomiting (PONV) and pruritus.
Measured: First 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 May 2026 (estimated)
- Primary completion1 May 2026
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turgutlu State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Celil Aslan, Turgutlu State Hospital
- Investigators
- Aslan, Principal investigator, Turgutlu State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267650
- Sponsor's protocol ID
- ANES-TKA-2025-001
- Status last verified
- May 2026
- First submitted
- 16 Nov 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the patient statistics
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Outcomes of iPACK Block Versus Periarticular Infiltration in Total Knee Arthroplasty: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07267650
- Acronym / sponsor ID
- ANES-TKA-2025-001
- Keywords
- Total Knee Arthroplasty, TKA, Postoperative Pain, Pain Management, Analgesia, Nerve Block, Femoral Triangle Block, FTB
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Turgutlu State HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Dec 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 retrospectively compare two different multimodal analgesic techniques for pain management after total knee arthroplasty (TKA). The primary purpose is to evaluate whether a combination of two specific nerve blocks administered by an anesthesiologist (Femoral Triangle Block + iPACK block) resulted in superior postoperative pain control compared to a hybrid combination of a nerve block and a local infiltration administered by the surgeon (FTB + Periarticular Infiltration [PAI]).
The hypothesis is that the FTB + iPACK combination is associated with a significant reduction in Numeric Rating Scale (NRS) pain scores with movement at 24 hours postoperatively. This is a retrospective, observational cohort study conducted at a single center, involving medical records of patients who underwent primary unilateral TKA. Data from patients who received either FTB + iPACK or FTB + PAI as part of their standard clinical care will be extracted and analyzed retrospectively.
Detailed description
Total knee arthroplasty (TKA) is a highly successful procedure for end-stage knee osteoarthritis but is associated with significant postoperative pain. Effective pain management is crucial for facilitating early rehabilitation and improving patient comfort. Modern pain management relies on multimodal, opioid-sparing protocols that often include motor-sparing regional anesthesia techniques like the femoral triangle block (FTB).
While FTB provides excellent analgesia for the anterior part of the knee, pain originating from the posterior knee capsule remains a significant challenge. This posterior pain is commonly managed either by the surgeon through a diffuse periarticular infiltration (PAI) of a local anesthetic cocktail or by the anesthesiologist through a targeted, ultrasound-guided block of the posterior capsule known as the iPACK block.
It is currently unclear whether a fully anesthesiologist-driven, neuroanatomically targeted approach (FTB + iPACK) offers superior clinical outcomes compared to a hybrid approach involving both the anesthesiologist and the surgeon (FTB + PAI). This retrospective study is designed to compare the clinical efficacy of these two advanced analgesic combinations by reviewing institutional patient registries. All included patients had previously received a standardized spinal anesthetic (3 mL of 0.5% heavy bupivacaine) followed by either of the regional analgesia protocols. The study evaluates postoperative pain control, measured primarily by Numeric Rating Scale (NRS) pain scores at 24 hours. Secondary outcomes include total rescue analgesic (tramadol) consumption, functional recovery (Timed Up and Go test and Straight Leg Raise test), and knee range of motion.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FTB + iPACK Group | – | –Patients who underwent primary unilateral TKA and received FTB + iPACK block as part of standard clinical care. |
| FTB + PAI Group | – | –Patients who underwent primary unilateral TKA and received FTB + PAI as part of standard clinical care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients who underwent elective, primary, unilateral total knee arthroplasty (TKA) under spinal anesthesia at Turgutlu State Hospital. Patient records and institutional registries will be reviewed retrospectively to identify eligible cases managed within a specific operational period (e.g., between December 2025 and May 2026). The cohort includes patients who received either an ultrasound-guided Femoral Triangle Block combined with an iPACK block or a hybrid combination of Femoral Triangle Block and surgeon-administered Periarticular Infiltration for postoperative analgesia as part of standard clinical care.
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status II-III.
- Scheduled for elective, primary, unilateral total knee arthroplasty for osteoarthritis.
- Able to provide written informed consent.
Key exclusion criteria (7 listed)
- Patient refusal to participate or contraindication to regional anesthesia.
- Known allergy to any study medications (local anesthetics, NSAIDs, tramadol, morphine, paracetamol).
- History of chronic opioid use (defined as daily use for >3 months)
- Pre-existing peripheral neuropathy in the operative limb.
- Severe renal or hepatic insufficiency.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Pain Score with Movement at 24 Hours
Time frame: 24 and 48. hours postoperatively
Pain assessed via Numeric Rating Scale (NRS) during active movement (e.g., active knee flexion or straight leg raise). Scale: 0 (no pain) to 10 (worst pain imaginable).
6 secondary outcomes
Postoperative Pain Scores (Time-Course)
Time frame: Assessed at 6, 12, and 24 hours postoperatively
Time to First Rescue Analgesia
Time frame: First 24 postoperative hours
Time Up to Go Test
Time frame: Assessed at 24 hours
Straight Leg Raise
Time frame: Postoperative 24. hour
Knee Range of Motion (ROM)
Time frame: Baseline (Preoperative) and 24 hours postoperatively
Incidence of Adverse Events
Time frame: First 48 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 1 Jun 2026.
- Individual participant dataSharing planned: Yes. All the patient statistics
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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.
Aslan principal investigator
Turgutlu State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Osteoarthritis, Knee / Osteoarthritis, Hip, run by Turgutlu State 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 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 1 Jun 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 Celil M Aslan, Medical Doctor (+90505534900, mcaslan@outlook.com.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score with Movement at 24 Hours (time frame: 24 and 48. hours postoperatively). 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 1 Jun 2026.