Total Knee ArthroplastyNCT07851506
Continuous Adductor Canal Block (CACB) Combined With İnfiltration Between the Popliteal Artery and Capsule of the Knee (iPACK) Block vs Continuous Adductor Canal Block Alone After Total Knee Arthroplasty
A study testing IPACK block and Continuous adductor canal block (CACB) in people with Total Knee Arthroplasty and Postoperative Pain, run by Başakşehir Çam & Sakura City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study compares the effects of adding an infiltration between the popliteal artery and capsule of the knee (iPACK) block to a continuous adductor canal block (CACB) versus continuous adductor canal block alone on postoperative analgesia, opioid consumption, early mobilization, and length of hospital stay in… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Pain
- What is being tested?
- IPACK block and Continuous adductor canal block (CACB)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2026to 11 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of either sex
- Aged 18 to 75 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Voluntary participation
- Fully oriented and able to cooperate with postoperative assessments
Who cannot join
- ASA physical status IV or V
- Patients who decline to participate
- Pediatric patients
- Active infection at the block site
- Chronic pain or regular analgesic use
- Coagulation disorders
Show all 10Show fewer
- Inability to cooperate with postoperative pain assessment
- Known allergy to local anesthetics
- Neuropathy or myopathy in the operated extremity
- Revision arthroplasty cases
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
Basaksehir Çam Ve Sakura City Hospital, İstanbul, Türkiye
Başakşehir, Istanbul, 34480
Muzaffer GENCER, MD, 905059436459, dr.m.gencer07@gmail.com
Murat Y MERSİN, MD, 905367736432, myasinmersin@gmail.com
About this study
Official title: Comparison of the Effects of iPACK Block Combined With Continuous Adductor Canal Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia, Early Mobilization, and Length of Hospital Stay in Total Knee Arthroplasty Cases
This study compares the effects of adding an infiltration between the popliteal artery and capsule of the knee (iPACK) block to a continuous adductor canal block (CACB) versus continuous adductor canal block alone on postoperative analgesia, opioid consumption, early mobilization, and length of hospital stay in patients undergoing total knee arthroplasty. This is a prospective, randomized, double-blind study with 54 patients allocated 1:1 into two groups.
Read the detailed description
Severe postoperative pain occurs in up to 58% of patients after total knee arthroplasty. Peripheral nerve blocks are an effective component of multimodal analgesia, and the continuous adductor canal block (CACB) has become a preferred technique because it provides sensory blockade while sparing motor function of the quadriceps, allowing earlier ambulation compared to femoral nerve block. However, CACB does not address posterior knee pain, which can be targeted by the iPACK (infiltration between the popliteal artery and capsule of the knee) block, a technique that blocks terminal sensory branches of the tibial and peroneal nerves without motor blockade.
In this study, patients scheduled for total knee arthroplasty will be randomized 1:1 (using randomizer.org) to receive either CACB alone (Group 2) or CACB combined with a single-injection iPACK block (Group 1). CACB will be maintained via a perineural catheter connected to a patient-controlled analgesia (PCA) pump delivering 0.1% bupivacaine. Rescue analgesia will be provided with intravenous tramadol (50 mg, max 300 mg/day) when the numeric rating scale (NRS) pain score exceeds 4.
Pain scores (NRS 0-10), total analgesic and opioid consumption, hemodynamic parameters, time to first mobilization (assessed via the Timed Up and Go test), patient satisfaction, and length of hospital stay will be recorded at baseline and at 1, 3, 6, 12, and 24 hours postoperatively by an anesthesiologist blinded to group allocation, different from the anesthesiologist who performed the block.
- Conditions
- Total Knee Arthroplasty, Postoperative Pain
- Being tested
- IPACK block, Continuous adductor canal block (CACB)
- Keywords
- Adductor Canal Block, iPACK Block, Total Knee Arthroplasty, Postoperative Analgesia, Early Mobilization, Regional Anesthesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACK blockProcedure or surgery
Single injection of 0.25% bupivacaine 20 mL between the popliteal artery and posterior knee capsule, performed under ultrasound guidance
Continuous adductor canal block (CACB)Procedure or surgery
Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (CACB + iPACK) | Experimental | Continuous adductor canal block (catheter, PCA with 0.1% bupivacaine) plus a single-injection iPACK block (0.25% bupivacaine 20 mL) Receives: Procedure: IPACK block; Procedure: Continuous adductor canal block (CACB) |
| Group 2 (CACB Alone) | Active comparator | Continuous adductor canal block alone (catheter, PCA with 0.1% bupivacaine) Receives: Procedure: Continuous adductor canal block (CACB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score (Numeric Rating Scale)
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable)
Measured: Baseline and postoperative hours 1, 3, 6, 12, and 24
Secondary outcomes (11)
Total Opioid Consumption
Total rescue analgesic (tramadol) consumption via intravenous (IV) administration
Measured: Postoperative 24 hours
Total Local Anesthetic Consumption
Total bupivacaine consumed via patient-controlled analgesia (PCA) pump
Measured: Postoperative 24 hours
Time to First Mobilization
Time to first unassisted ambulation/movement, assessed via the Timed Up and Go (TUG) test
Measured: Postoperative 24 hours
Length of Hospital Stay
Number of days from surgery to discharge
Measured: From surgery to discharge (up to approximately 1 week)
Patient Satisfaction Score
Satisfaction rated on a 4-point scale (1 = not satisfied, 2 = Slightly satisfied, 3 = Satisfied, 4 = very satisfied)
Measured: Postoperative 24 hours
Systolic Blood Pressure
Systolic blood pressure measured in mmHg
Measured: Baseline and postoperative hours 1, 3, 6, 12, and 24
Diastolic Blood Pressure
Diastolic blood pressure measured in mmHg
Measured: Baseline and postoperative hours 1, 3, 6, 12, and 24
Mean Arterial Blood Pressure
Mean arterial blood pressure (MAP) measured in mmHg
Measured: Baseline and postoperative hours 1, 3, 6, 12, and 24
Heart Rate
Heart rate measured in beats per minute
Measured: Baseline and postoperative hours 1, 3, 6, 12, and 24
Peripheral Oxygen Saturation
Peripheral oxygen saturation (SpO2) measured as a percentage
Measured: Baseline and postoperative hours 1, 3, 6, 12, and 24
Block-Related Complications
Incidence of complications associated with the regional block techniques (e.g., nerve injury, infection)
Measured: Throughout study participation (up to 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 posted1 Oct 2026
- Study start25 Sep 2026 (estimated)
- Primary completion4 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Başakşehir Çam & Sakura City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Furkan Tontu, Başakşehir Çam & Sakura City Hospital
- Investigators
- Furkan TONTU, MD, Principal investigator, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİMuzaffer GENCER, MD, Study director, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİMurat Y Mersin, MD, Study director, BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851506
- Sponsor's protocol ID
- BSH-ANES-MYM-02
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared beyond what is reported in publications resulting from this study.
Publications
Diz Protezi Ameliyatı Sonrası Sürekli Adduktör Kanal Bloğuna Popliteal Arter ve Diz Kapsülü Arası İnfiltrasyon Bloğunun (IPACK) Eklenmesinin Etkisi DOI: 10.1080/11101849.2023.2246732
Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
PubMed 28861197
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of iPACK Block Combined With Continuous Adductor Canal Block Versus Continuous Adductor Canal Block Alone on Postoperative Analgesia, Early Mobilization, and Length of Hospital Stay in Total Knee Arthroplasty Cases
- ClinicalTrials.gov ID
- NCT07851506
- Acronym / sponsor ID
- BSH-ANES-MYM-02
- Conditions
- Total Knee Arthroplasty, Postoperative Pain
- Keywords
- Adductor Canal Block, iPACK Block, Total Knee Arthroplasty, Postoperative Analgesia, Early Mobilization, Regional Anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Başakşehir Çam & Sakura City HospitalOther government
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 1 Oct 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 compares the effects of adding an infiltration between the popliteal artery and capsule of the knee (iPACK) block to a continuous adductor canal block (CACB) versus continuous adductor canal block alone on postoperative analgesia, opioid consumption, early mobilization, and length of hospital stay in patients undergoing total knee arthroplasty. This is a prospective, randomized, double-blind study with 54 patients allocated 1:1 into two groups.
Detailed description
Severe postoperative pain occurs in up to 58% of patients after total knee arthroplasty. Peripheral nerve blocks are an effective component of multimodal analgesia, and the continuous adductor canal block (CACB) has become a preferred technique because it provides sensory blockade while sparing motor function of the quadriceps, allowing earlier ambulation compared to femoral nerve block. However, CACB does not address posterior knee pain, which can be targeted by the iPACK (infiltration between the popliteal artery and capsule of the knee) block, a technique that blocks terminal sensory branches of the tibial and peroneal nerves without motor blockade.
In this study, patients scheduled for total knee arthroplasty will be randomized 1:1 (using randomizer.org) to receive either CACB alone (Group 2) or CACB combined with a single-injection iPACK block (Group 1). CACB will be maintained via a perineural catheter connected to a patient-controlled analgesia (PCA) pump delivering 0.1% bupivacaine. Rescue analgesia will be provided with intravenous tramadol (50 mg, max 300 mg/day) when the numeric rating scale (NRS) pain score exceeds 4.
Pain scores (NRS 0-10), total analgesic and opioid consumption, hemodynamic parameters, time to first mobilization (assessed via the Timed Up and Go test), patient satisfaction, and length of hospital stay will be recorded at baseline and at 1, 3, 6, 12, and 24 hours postoperatively by an anesthesiologist blinded to group allocation, different from the anesthesiologist who performed the block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (CACB + iPACK) | Experimental | Procedure: IPACK block, Procedure: Continuous adductor canal block (CACB)Continuous adductor canal block (catheter, PCA with 0.1% bupivacaine) plus a single-injection iPACK block (0.25% bupivacaine 20 mL) |
| Group 2 (CACB Alone) | Active comparator | Procedure: Continuous adductor canal block (CACB)Continuous adductor canal block alone (catheter, PCA with 0.1% bupivacaine) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of either sex
- Aged 18 to 75 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Voluntary participation
- Fully oriented and able to cooperate with postoperative assessments
Key exclusion criteria (10 listed)
- ASA physical status IV or V
- Patients who decline to participate
- Pediatric patients
- Active infection at the block site
- Chronic pain or regular analgesic use
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 |
|---|---|---|
| IPACK blockSingle injection of 0.25% bupivacaine 20 mL between the popliteal artery and posterior knee capsule, performed under ultrasound guidance | Procedure or surgery | Group 1 (CACB + iPACK) |
| Continuous adductor canal block (CACB)Perineural catheter placement in the adductor canal with PCA-delivered 0.1% bupivacaine (5-7 mL basal rate, 5 mL bolus, 30-min lockout) for 24 hours postoperatively | Procedure or surgery | Group 1 (CACB + iPACK), Group 2 (CACB Alone) |
Primary outcome
Postoperative Pain Score (Numeric Rating Scale)
Time frame: Baseline and postoperative hours 1, 3, 6, 12, and 24
Pain intensity assessed using the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst pain imaginable)
11 secondary outcomes
Total Opioid Consumption
Time frame: Postoperative 24 hours
Total Local Anesthetic Consumption
Time frame: Postoperative 24 hours
Time to First Mobilization
Time frame: Postoperative 24 hours
Length of Hospital Stay
Time frame: From surgery to discharge (up to approximately 1 week)
Patient Satisfaction Score
Time frame: Postoperative 24 hours
Systolic Blood Pressure
Time frame: Baseline and postoperative hours 1, 3, 6, 12, and 24
Diastolic Blood Pressure
Time frame: Baseline and postoperative hours 1, 3, 6, 12, and 24
Mean Arterial Blood Pressure
Time frame: Baseline and postoperative hours 1, 3, 6, 12, and 24
Heart Rate
Time frame: Baseline and postoperative hours 1, 3, 6, 12, and 24
Peripheral Oxygen Saturation
Time frame: Baseline and postoperative hours 1, 3, 6, 12, and 24
Block-Related Complications
Time frame: Throughout study participation (up to 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 1 Oct 2026.
- BackgroundDiz Protezi Ameliyatı Sonrası Sürekli Adduktör Kanal Bloğuna Popliteal Arter ve Diz Kapsülü Arası İnfiltrasyon Bloğunun (IPACK) Eklenmesinin Etkisi DOI: 10.1080/11101849.2023.2246732
- Background: PubMed 28861197Seo SS, Kim OG, Seo JH, Kim DH, Kim YG, Park BY. Comparison of the Effect of Continuous Femoral Nerve Block and Adductor Canal Block after Primary Total Knee Arthroplasty. Clin Orthop Surg. 2017 Sep;9(3):303-309. doi: 10.4055/cios.2017.9.3.303. Epub 2017 Aug 4.
- Individual participant dataSharing planned: No. Individual participant data will not be shared beyond what is reported in publications resulting from this study.
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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.
Furkan TONTU, MD principal investigator
BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
Muzaffer GENCER, MD study director
BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİ
Murat Y Mersin, MD study director
BAŞAKŞEHİR ÇAM VE SAKURA ŞEHİR HASTANESİt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPACK block and Continuous adductor canal block (CACB) in people with Total Knee Arthroplasty and Postoperative Pain, run by Başakşehir Çam & Sakura City 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 5 inclusion and 10 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 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?
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 Muzaffer GENCER, MD (905059436459, dr.m.gencer07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score (Numeric Rating Scale) (time frame: Baseline and postoperative hours 1, 3, 6, 12, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07851506, which also lists 2 linked publications.
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 Oct 2026.