Postoperative Pain, AcuteNCT06586840
The Effect of Adding an IPACK Block to the Adductor Canal Block on Total Knee Arthroplasty Surgery
An observational study of Postoperative Pain, Acute, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- rescue analgesia, Adductor Canal Block and Adding an IPACK Block to the Adductor Canal Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2024to 15 Dec 2024
- How long will I take part?
- 5 Days
- Phase
- Observational
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Once eligibility is confirmed, patients will receive complete oral and written information about the study. Informed consent will be obtained before randomization and study-specific procedures.
Who may be able to join
- Patients with written informed consent
- Patients over 18 years old undergoing elective total knee arthroplasty surgery
- Patients with ASA I-II-III
- Patients receiving spinal anesthesia
Who cannot join
- Revision knee arthroplasty and bilateral total knee arthroplasty
- Liver or kidney failure
- Patients under 18 years old
- Patients receiving general anesthesia
- Allergy or intolerance to study medications
- Body mass index (BMI) > 40 kg/m²
Show all 9Show fewer
- Chronic use of gabapentin/pregabalin (regular use for more than 3 months)
- Chronic opioid use (opioid use for more than 3 months or daily oral morphine equivalent > 5 mg/day for 1 month)
- Patients with ASA IV and those undergoing emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Adding an IPACK Block to the Adductor Canal Block on Postoperative Pain and Hospital Stay in Patients Undergoing Total Knee Arthroplasty Surgery
Total knee arthroplasty (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to prolonged hospital stay. Optimal postoperative knee analgesia is crucial not only for patient comfort and satisfaction but also for accelerating mobilization, functional recovery, and discharge from the hospital. To facilitate early ambulation and superior performance, multimodal analgesia and motor-sparing blocks are increasingly utilized
Read the detailed description
In total knee arthroplasty, a pain management method that preserves motor strength is increasingly accepted as part of the perioperative rehabilitation protocol. Although peripheral nerve blocks like the femoral nerve block (FNB) can cause significant loss of quadriceps muscle strength and delayed rehabilitation due to the risk of patient falls, growing evidence supports the use of the Total knee arthroplasty (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to prolonged hospital stay. Optimal postoperative knee analgesia is crucial not only for patient comfort and satisfaction but also for accelerating mobilization, functional recovery, and discharge from the hospital. To facilitate early ambulation and superior performance, multimodal analgesia and motor-sparing blocks are increasingly utilized.
Regional anesthesia techniques are among the most effective methods for postoperative analgesia. Peripheral nerve blocks, a type of regional anesthesia, provide ideal postoperative analgesia due to their ability to offer effective analgesia, reduce opioid requirements and associated side effects, and facilitate recovery by effectively managing dynamic pain.
The innervation of the knee joint is supplied by branches from the femoral nerve, obturator nerve, common peroneal nerve, and tibial nerve, which originate from the lumbar and sacral plexuses responsible for lower extremity innervation.
adductor canal block (ACB) in total knee arthroplasty patients for minimal motor involvement or purely sensory block.
The adductor canal block (ACB) is a predominantly sensory nerve block that includes the saphenous nerve, the nerve to the vastus medialis muscle, and the articular branches of the obturator nerve. When performed successfully, it provides analgesia similar to the femoral nerve block without significant motor loss in the thigh. It is primarily used for lower extremity surgeries such as total knee arthroplasty, anterior cruciate ligament reconstruction, and meniscus repair.
There is increasing interest in the technique called iPACK (infiltration between the popliteal artery and capsule of the knee), which involves injecting local anesthetics into the space between the popliteal artery and the posterior capsule of the knee. This approach blocks the terminal branches of the genicular nerves and the popliteal plexus, which innervate the posterior capsule of the knee, while sparing the main trunks of the tibial and common peroneal nerves. Therefore, the iPACK block appears advantageous by providing motor-sparing posterior knee analgesia with a lower likelihood of nerve or vascular injury under ultrasound guidance. Studies have shown that combining ACB with the iPACK block provides significantly better postoperative numerical rating scale (NRS) scores, knee range of motion, and ambulation distances compared to ACB alone.
- Conditions
- Postoperative Pain, Acute
- Being tested
- rescue analgesia, Adductor Canal Block, Adding an IPACK Block to the Adductor Canal Block
- Keywords
- adductor canal block, knee arthroplasty, ipack
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rescue analgesiaOther
. If NRS is 4 or higher in the postoperative recovery room, 100 mg of intravenous tramadol will be administered as rescue analgesia
Adductor Canal BlockProcedure or surgery
For Group I, after patients are placed in the supine position, a linear ultrasound probe (13-6 MHz) will be used to identify the superficial femoral artery in the short axis, lateral to the Sartorius muscle, and anterior to the adductor magnus muscle in the adductor canal. A 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially under sterile conditions, and 20 mL of 0.5% bupivacaine will be injected after negative aspiration.
Adding an IPACK Block to the Adductor Canal BlockProcedure or surgery
For Group II, 20 mL of 0.25% bupivacaine will be injected into the Adductor Canal after spinal anesthesia. With the knee flexed, a convex probe (3.5-6 MHz) will be placed in the popliteal region to identify the popliteal artery in the short axis. The ultrasound probe will be moved distally after the common peroneal and tibial nerves are identified. The probe will be gradually moved towards the popliteal fossa until the popliteal vessels are identified superficially. The ultrasound probe will be moved to the level where the femoral condyles merge with the femoral shaft. The popliteal artery, tibial and peroneal nerves will be visualized to identify the space between the femur and the popliteal artery. In the area known as iPACK, a 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially, and 20 mL of 0.25% bupivacaine will be injected after negative aspiration.
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal Block | For Group I, after patients are placed in the supine position, a linear ultrasound probe (13-6 MHz) will be used to identify the superficial femoral artery in the short axis, lateral to the Sartorius muscle, and anterior to the adductor magnus muscle in the adductor canal. A 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially under sterile conditions, and 20 mL of 0.5% bupivacaine will be injected after negative aspiration. Receives: Other: rescue analgesia; Procedure: Adductor Canal Block | |
| Adding an IPACK Block to the Adductor Canal Block | For Group II, 20 mL of 0.25% bupivacaine will be injected into the Adductor Canal after spinal anesthesia. With the knee flexed, a convex probe (3.5-6 MHz) will be placed in the popliteal region to identify the popliteal artery in the short axis. The ultrasound probe will be moved distally after the common peroneal and tibial nerves are identified. The probe will be gradually moved towards the popliteal fossa until the popliteal vessels are identified superficially. The ultrasound probe will be moved to the level where the femoral condyles merge with the femoral shaft. The popliteal artery, tibial and peroneal nerves will be visualized to identify the space between the femur and the popliteal artery. In the area known as iPACK, a 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially, and 20 mL of 0.25% bupivacaine will be injected after negative aspiration. Receives: Other: rescue analgesia; Procedure: Adding an IPACK Block to the Adductor Canal Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the comparison of discharge times between patients undergoing total knee arthroplasty who receive an adductor canal block with and without the addition of an iPACK block.
Total Knee Arthroplasty surgery results in shorter hospital stays
Measured: Until discharge after surgery(Up to 6 days after the surgery)
Secondary outcomes (1)
The secondary outcome will be the assessment of whether the addition of an iPACK block to the adductor canal block reduces postoperative opioid consumption and pain scores by 50%, which will be considered significant.
İt is a pain intensity determination system based on the system where there person tells a point between 0=(no pain) 10=( unbearable pain) and to describe their pain
Measured: Acute pain will be assessed after surgery until discharge(Up to 6 days after the surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Jan 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 105 participants (actual)
- Target duration
- 5 Days
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MURAT DEMİRCİOGLU, Aydin Adnan Menderes University
- Investigators
- MURAT DEMİRCİOGLU, Study chair, muratdemircioglu01@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06586840
- Sponsor's protocol ID
- 2023/07/01
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2024
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adding an IPACK Block to the Adductor Canal Block on Postoperative Pain and Hospital Stay in Patients Undergoing Total Knee Arthroplasty Surgery
- ClinicalTrials.gov ID
- NCT06586840
- Acronym / sponsor ID
- 2023/07/01
- Conditions
- Postoperative Pain, Acute
- Keywords
- adductor canal block, knee arthroplasty, ipack
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 19 Sep 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 (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to prolonged hospital stay. Optimal postoperative knee analgesia is crucial not only for patient comfort and satisfaction but also for accelerating mobilization, functional recovery, and discharge from the hospital. To facilitate early ambulation and superior performance, multimodal analgesia and motor-sparing blocks are increasingly utilized
Detailed description
In total knee arthroplasty, a pain management method that preserves motor strength is increasingly accepted as part of the perioperative rehabilitation protocol. Although peripheral nerve blocks like the femoral nerve block (FNB) can cause significant loss of quadriceps muscle strength and delayed rehabilitation due to the risk of patient falls, growing evidence supports the use of the Total knee arthroplasty (TKA) is a frequently performed major orthopedic surgery, where most patients experience severe postoperative pain. Pain-related delays in patient mobilization can lead to thromboembolism, deep vein thrombosis, surgical site infection, and increased risk of hospital-acquired infections due to prolonged hospital stay. Optimal postoperative knee analgesia is crucial not only for patient comfort and satisfaction but also for accelerating mobilization, functional recovery, and discharge from the hospital. To facilitate early ambulation and superior performance, multimodal analgesia and motor-sparing blocks are increasingly utilized.
Regional anesthesia techniques are among the most effective methods for postoperative analgesia. Peripheral nerve blocks, a type of regional anesthesia, provide ideal postoperative analgesia due to their ability to offer effective analgesia, reduce opioid requirements and associated side effects, and facilitate recovery by effectively managing dynamic pain.
The innervation of the knee joint is supplied by branches from the femoral nerve, obturator nerve, common peroneal nerve, and tibial nerve, which originate from the lumbar and sacral plexuses responsible for lower extremity innervation.
adductor canal block (ACB) in total knee arthroplasty patients for minimal motor involvement or purely sensory block.
The adductor canal block (ACB) is a predominantly sensory nerve block that includes the saphenous nerve, the nerve to the vastus medialis muscle, and the articular branches of the obturator nerve. When performed successfully, it provides analgesia similar to the femoral nerve block without significant motor loss in the thigh. It is primarily used for lower extremity surgeries such as total knee arthroplasty, anterior cruciate ligament reconstruction, and meniscus repair.
There is increasing interest in the technique called iPACK (infiltration between the popliteal artery and capsule of the knee), which involves injecting local anesthetics into the space between the popliteal artery and the posterior capsule of the knee. This approach blocks the terminal branches of the genicular nerves and the popliteal plexus, which innervate the posterior capsule of the knee, while sparing the main trunks of the tibial and common peroneal nerves. Therefore, the iPACK block appears advantageous by providing motor-sparing posterior knee analgesia with a lower likelihood of nerve or vascular injury under ultrasound guidance. Studies have shown that combining ACB with the iPACK block provides significantly better postoperative numerical rating scale (NRS) scores, knee range of motion, and ambulation distances compared to ACB alone.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal Block | – | Other: rescue analgesia, Procedure: Adductor Canal BlockFor Group I, after patients are placed in the supine position, a linear ultrasound probe (13-6 MHz) will be used to identify the superficial femoral artery in the short axis, lateral to the Sartorius muscle, and anterior to the adductor magnus muscle in the adductor canal. A 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially under sterile conditions, and 20 mL of 0.5% bupivacaine will be injected after negative aspiration. |
| Adding an IPACK Block to the Adductor Canal Block | – | Other: rescue analgesia, Procedure: Adding an IPACK Block to the Adductor Canal BlockFor Group II, 20 mL of 0.25% bupivacaine will be injected into the Adductor Canal after spinal anesthesia. With the knee flexed, a convex probe (3.5-6 MHz) will be placed in the popliteal region to identify the popliteal artery in the short axis. The ultrasound probe will be moved distally after the common peroneal and tibial nerves are identified. The probe will be gradually moved towards the popliteal fossa until the popliteal vessels are identified superficially. The ultrasound probe will be moved to the level where the femoral condyles merge with the femoral shaft. The popliteal artery, tibial and peroneal nerves will be visualized to identify the space between the femur and the popliteal artery. In the area known as iPACK, a 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially, and 20 mL of 0.25% bupivacaine will be injected after negative aspiration. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Once eligibility is confirmed, patients will receive complete oral and written information about the study. Informed consent will be obtained before randomization and study-specific procedures.
Key inclusion criteria (4 listed)
- Patients with written informed consent
- Patients over 18 years old undergoing elective total knee arthroplasty surgery
- Patients with ASA I-II-III
- Patients receiving spinal anesthesia
Key exclusion criteria (9 listed)
- Revision knee arthroplasty and bilateral total knee arthroplasty
- Liver or kidney failure
- Patients under 18 years old
- Patients receiving general anesthesia
- Allergy or intolerance to 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 |
|---|---|---|
| rescue analgesia. If NRS is 4 or higher in the postoperative recovery room, 100 mg of intravenous tramadol will be administered as rescue analgesia | Other | Adding an IPACK Block to the Adductor Canal Block, Adductor Canal Block |
| Adductor Canal BlockFor Group I, after patients are placed in the supine position, a linear ultrasound probe (13-6 MHz) will be used to identify the superficial femoral artery in the short axis, lateral to the Sartorius muscle, and anterior to the adductor magnus muscle in the adductor canal. A 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially under sterile conditions, and 20 mL of 0.5% bupivacaine will be injected after negative aspiration. | Procedure or surgery | Adductor Canal Block |
| Adding an IPACK Block to the Adductor Canal BlockFor Group II, 20 mL of 0.25% bupivacaine will be injected into the Adductor Canal after spinal anesthesia. With the knee flexed, a convex probe (3.5-6 MHz) will be placed in the popliteal region to identify the popliteal artery in the short axis. The ultrasound probe will be moved distally after the common peroneal and tibial nerves are identified. The probe will be gradually moved towards the popliteal fossa until the popliteal vessels are identified superficially. The ultrasound probe will be moved to the level where the femoral condyles merge with the femoral shaft. The popliteal artery, tibial and peroneal nerves will be visualized to identify the space between the femur and the popliteal artery. In the area known as iPACK, a 22-gauge × 100 mm needle (Braun® Stimuplex) will be inserted in-plane laterally to medially, and 20 mL of 0.25% bupivacaine will be injected after negative aspiration. | Procedure or surgery | Adding an IPACK Block to the Adductor Canal Block |
Primary outcome
The primary outcome will be the comparison of discharge times between patients undergoing total knee arthroplasty who receive an adductor canal block with and without the addition of an iPACK block.
Time frame: Until discharge after surgery(Up to 6 days after the surgery)
Total Knee Arthroplasty surgery results in shorter hospital stays
1 secondary outcome
The secondary outcome will be the assessment of whether the addition of an iPACK block to the adductor canal block reduces postoperative opioid consumption and pain scores by 50%, which will be considered significant.
Time frame: Acute pain will be assessed after surgery until discharge(Up to 6 days after the surgery)
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 16 Oct 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. This study is not recruiting at the moment.
MURAT DEMİRCİOGLU study chair
muratdemircioglu01@gmail.com
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 Postoperative Pain, Acute, run by Aydin Adnan Menderes University 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 16 Oct 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?
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?
The primary outcome will be the comparison of discharge times between patients undergoing total knee arthroplasty who receive an adductor canal block with and without the addition of an iPACK block. (time frame: Until discharge after surgery(Up to 6 days after the surgery)). 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 16 Oct 2026.