Arthropathy of KneeNCT07442123
Peripheral Nerve Blocks and Postoperative Pain and Mobilization After Total Knee Arthroplasty
An observational study of Arthropathy of Knee and Early Ambulation, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Total knee arthroplasty (TKA) is frequently associated with significant postoperative pain, which may delay early mobilization and negatively affect functional recovery. Peripheral nerve blocks are widely used as part of multimodal analgesia strategies to improve postoperative pain control while minimizing opioid… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthropathy of Knee, Early Ambulation, Pain, Postoperative
- What is being tested?
- Fascia Iliaca Plane Block and Adductor Canal Block + IPACK Block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 15 Jan 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients undergoing elective unilateral total knee arthroplasty at a tertiary care hospital. Eligible participants include patients receiving spinal anesthesia and perioperative peripheral nerve block analgesia as part of routine clinical practice. The population represents individuals undergoing primary knee replacement surgery for degenerative joint disease who are suitable for early postoperative mobilization and standardized postoperative pain management protocols.
Who may be able to join
- Adult patients aged 18-80 years
- Scheduled for elective unilateral total knee arthroplasty
- Surgery performed under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide informed consent
Who cannot join
- Refusal to participate
- Contraindications to spinal anesthesia or peripheral nerve block
- Known allergy to local anesthetics
- Chronic opioid use or opioid dependence
- Preexisting neurological or neuromuscular disorders affecting lower extremities
- Cognitive impairment preventing pain assessment
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy contraindicating regional anesthesia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, 06200
About this study
Official title: Comparison of the Effects of Peripheral Nerve Blocks Applied in Total Knee Arthroplasty on Pain Control and Mobilization: A Prospective Observational Study
Total knee arthroplasty (TKA) is frequently associated with significant postoperative pain, which may delay early mobilization and negatively affect functional recovery. Peripheral nerve blocks are widely used as part of multimodal analgesia strategies to improve postoperative pain control while minimizing opioid consumption and preserving motor function. Different peripheral nerve block techniques may result in varying analgesic efficacy and mobilization outcomes.
The aim of this prospective observational study is to compare the effects of commonly used peripheral nerve block techniques on postoperative pain control and early mobilization in patients undergoing total knee arthroplasty under spinal anesthesia. Patients receiving fascia iliaca plane block are compared with those receiving a combination of adductor canal block and interspace between the popliteal artery and capsule of the knee (IPACK) block.
The primary outcome is postoperative opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores assessed at predefined time intervals, early mobilization parameters, and opioid-related adverse effects. The findings of this study are intended to contribute to optimizing analgesic strategies and improving early functional recovery following total knee arthroplasty.
Read the detailed description
Total knee arthroplasty (TKA) is a commonly performed orthopedic procedure associated with moderate to severe postoperative pain that may impair early mobilization and delay rehabilitation. Effective postoperative analgesia is essential to facilitate early functional recovery, reduce opioid consumption, and minimize postoperative complications. Multimodal analgesia strategies incorporating peripheral nerve blocks have become increasingly important in postoperative pain management following TKA.
Peripheral nerve block techniques aim to provide effective analgesia while preserving motor function to support early ambulation. Traditional proximal blocks may provide adequate pain relief but can be associated with motor weakness that limits mobilization. More distal techniques, such as the adductor canal block, are increasingly preferred due to their motor-sparing characteristics. The interspace between the popliteal artery and capsule of the knee (IPACK) block has been introduced to improve posterior knee analgesia without affecting motor function. The fascia iliaca plane block represents another commonly used regional anesthesia technique; however, comparative clinical data regarding analgesic efficacy and mobilization outcomes between these approaches remain limited.
This prospective observational study is conducted in patients undergoing unilateral total knee arthroplasty under spinal anesthesia. Participants receive either fascia iliaca plane block or a combination of adductor canal block and IPACK block as part of routine clinical practice. The study evaluates postoperative outcomes during the first 24 hours following surgery.
The primary objective is to compare total opioid consumption within the first 24 postoperative hours between the two peripheral nerve block techniques. Secondary objectives include assessment of postoperative pain intensity using the Numeric Rating Scale (NRS) at predefined time points, evaluation of early mobilization parameters, and comparison of opioid-related adverse effects.
Pain assessments are performed at 0, 2, 6, 12, and 24 hours postoperatively. Early mobilization is evaluated using standardized functional assessments, including walking ability and motor function tests of quadriceps and ankle dorsiflexor muscles. All patients receive standardized spinal anesthesia and postoperative patient-controlled analgesia to ensure comparable perioperative management.
The results of this study are expected to provide clinical evidence regarding the comparative effectiveness of commonly used peripheral nerve block techniques and to support optimization of postoperative analgesia protocols aimed at improving recovery after total knee arthroplasty.
- Being tested
- Fascia Iliaca Plane Block, Adductor Canal Block + IPACK Block
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia Iliaca Plane BlockProcedure or surgery
Ultrasound-guided fascia iliaca plane block is performed under sterile conditions prior to surgery as part of perioperative analgesia. Using an in-plane technique with a high-frequency linear ultrasound probe, the needle is advanced beneath the fascia iliaca, and 40 mL of 0.25% bupivacaine is injected incrementally after negative aspiration to achieve spread within the fascia iliaca compartment.
Adductor Canal Block + IPACK BlockProcedure or surgery
An ultrasound-guided adductor canal block followed by an interspace between the popliteal artery and capsule of the knee (IPACK) block is performed prior to surgery as part of perioperative analgesia. The adductor canal block is administered using 20 mL of 0.25% bupivacaine injected adjacent to the femoral artery beneath the sartorius muscle. Subsequently, the IPACK block is performed with 20 mL of 0.25% bupivacaine injected into the tissue plane between the popliteal artery and the posterior capsule of the knee under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Fascia Iliaca Plane Block | Participants in this cohort receive an ultrasound-guided fascia iliaca plane block prior to surgery as part of routine perioperative analgesia. The block is performed under sterile conditions using an in-plane technique with a high-frequency linear ultrasound probe. A total volume of 40 mL of 0.25% bupivacaine is administered within the fascia iliaca compartment. All patients undergo spinal anesthesia for total knee arthroplasty and receive standardized postoperative patient-controlled analgesia. Receives: Procedure: Fascia Iliaca Plane Block | |
| Adductor Canal + IPACK Block | Participants in this cohort receive a combination of ultrasound-guided adductor canal block and interspace between the popliteal artery and capsule of the knee (IPACK) block prior to surgery as part of routine perioperative analgesia. The adductor canal block is performed with 20 mL of 0.25% bupivacaine, followed by an IPACK block using 20 mL of 0.25% bupivacaine under ultrasound guidance. All patients undergo spinal anesthesia for total knee arthroplasty and receive standardized postoperative patient-controlled analgesia. Receives: Procedure: Adductor Canal Block + IPACK Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Opioid Consumption
Total opioid consumption administered via patient-controlled analgesia (PCA) during the first 24 hours following total knee arthroplasty. Opioid use is recorded as the cumulative dose of morphine (mg) delivered by the PCA device.
Measured: Within the first 24 hours after surgery
Secondary outcomes (2)
Postoperative Pain Intensity (NRS Score)
Postoperative pain intensity assessed using the Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores are recorded at predefined postoperative time points under resting conditions.
Measured: 0, 2, 6, 12, and 24 hours after surgery
Early Mobilization Performance
Early postoperative mobilization assessed using standardized functional evaluations, including walking ability, quadriceps muscle strength, and ankle dorsiflexor motor function scores recorded at postoperative assessment.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Dec 2022
- Primary completion1 Dec 2024
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Arthropathy of 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guldeniz Argun, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442123
- Sponsor's protocol ID
- 2022-11/2120
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data collected during this study will not be made publicly available. De-identified data may be shared upon reasonable request to the corresponding author, subject to institutional approval and applicable ethical and legal regulations.
Publications
Mou P, Wang D, Tang XM, Zeng WN, Zeng Y, Yang J, Zhou ZK. Adductor Canal Block Combined With IPACK Block for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study. J Arthroplasty. 2022 Feb;37(2):259-266. doi: 10.1016/j.arth.2021.10.004. Epub 2021 Oct 13.
PubMed 34653576Et T, Korkusuz M, Basaran B, Yarimoglu R, Toprak H, Bilge A, Kumru N, Dedeli I. Comparison of iPACK and periarticular block with adductor block alone after total knee arthroplasty: a randomized clinical trial. J Anesth. 2022 Apr;36(2):276-286. doi: 10.1007/s00540-022-03047-6. Epub 2022 Feb 14.
PubMed 35157136Kertkiatkachorn W, Kampitak W, Tanavalee A, Ngarmukos S. Adductor Canal Block Combined With iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block vs Periarticular Injection for Analgesia After Total Knee Arthroplasty: A Randomized Noninferiority Trial. J Arthroplasty. 2021 Jan;36(1):122-129.e1. doi: 10.1016/j.arth.2020.06.086. Epub 2020 Jul 2.
PubMed 32694032
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Peripheral Nerve Blocks Applied in Total Knee Arthroplasty on Pain Control and Mobilization: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07442123
- Acronym / sponsor ID
- 2022-11/2120
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 2 Mar 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.
Total knee arthroplasty (TKA) is frequently associated with significant postoperative pain, which may delay early mobilization and negatively affect functional recovery. Peripheral nerve blocks are widely used as part of multimodal analgesia strategies to improve postoperative pain control while minimizing opioid consumption and preserving motor function. Different peripheral nerve block techniques may result in varying analgesic efficacy and mobilization outcomes.
The aim of this prospective observational study is to compare the effects of commonly used peripheral nerve block techniques on postoperative pain control and early mobilization in patients undergoing total knee arthroplasty under spinal anesthesia. Patients receiving fascia iliaca plane block are compared with those receiving a combination of adductor canal block and interspace between the popliteal artery and capsule of the knee (IPACK) block.
The primary outcome is postoperative opioid consumption within the first 24 hours after surgery. Secondary outcomes include postoperative pain scores assessed at predefined time intervals, early mobilization parameters, and opioid-related adverse effects. The findings of this study are intended to contribute to optimizing analgesic strategies and improving early functional recovery following total knee arthroplasty.
Detailed description
Total knee arthroplasty (TKA) is a commonly performed orthopedic procedure associated with moderate to severe postoperative pain that may impair early mobilization and delay rehabilitation. Effective postoperative analgesia is essential to facilitate early functional recovery, reduce opioid consumption, and minimize postoperative complications. Multimodal analgesia strategies incorporating peripheral nerve blocks have become increasingly important in postoperative pain management following TKA.
Peripheral nerve block techniques aim to provide effective analgesia while preserving motor function to support early ambulation. Traditional proximal blocks may provide adequate pain relief but can be associated with motor weakness that limits mobilization. More distal techniques, such as the adductor canal block, are increasingly preferred due to their motor-sparing characteristics. The interspace between the popliteal artery and capsule of the knee (IPACK) block has been introduced to improve posterior knee analgesia without affecting motor function. The fascia iliaca plane block represents another commonly used regional anesthesia technique; however, comparative clinical data regarding analgesic efficacy and mobilization outcomes between these approaches remain limited.
This prospective observational study is conducted in patients undergoing unilateral total knee arthroplasty under spinal anesthesia. Participants receive either fascia iliaca plane block or a combination of adductor canal block and IPACK block as part of routine clinical practice. The study evaluates postoperative outcomes during the first 24 hours following surgery.
The primary objective is to compare total opioid consumption within the first 24 postoperative hours between the two peripheral nerve block techniques. Secondary objectives include assessment of postoperative pain intensity using the Numeric Rating Scale (NRS) at predefined time points, evaluation of early mobilization parameters, and comparison of opioid-related adverse effects.
Pain assessments are performed at 0, 2, 6, 12, and 24 hours postoperatively. Early mobilization is evaluated using standardized functional assessments, including walking ability and motor function tests of quadriceps and ankle dorsiflexor muscles. All patients receive standardized spinal anesthesia and postoperative patient-controlled analgesia to ensure comparable perioperative management.
The results of this study are expected to provide clinical evidence regarding the comparative effectiveness of commonly used peripheral nerve block techniques and to support optimization of postoperative analgesia protocols aimed at improving recovery after total knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fascia Iliaca Plane Block | – | Procedure: Fascia Iliaca Plane BlockParticipants in this cohort receive an ultrasound-guided fascia iliaca plane block prior to surgery as part of routine perioperative analgesia. The block is performed under sterile conditions using an in-plane technique with a high-frequency linear ultrasound probe. A total volume of 40 mL of 0.25% bupivacaine is administered within the fascia iliaca compartment. All patients undergo spinal anesthesia for total knee arthroplasty and receive standardized postoperative patient-controlled analgesia. |
| Adductor Canal + IPACK Block | – | Procedure: Adductor Canal Block + IPACK BlockParticipants in this cohort receive a combination of ultrasound-guided adductor canal block and interspace between the popliteal artery and capsule of the knee (IPACK) block prior to surgery as part of routine perioperative analgesia. The adductor canal block is performed with 20 mL of 0.25% bupivacaine, followed by an IPACK block using 20 mL of 0.25% bupivacaine under ultrasound guidance. All patients undergo spinal anesthesia for total knee arthroplasty and receive standardized postoperative patient-controlled analgesia. |
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 undergoing elective unilateral total knee arthroplasty at a tertiary care hospital. Eligible participants include patients receiving spinal anesthesia and perioperative peripheral nerve block analgesia as part of routine clinical practice. The population represents individuals undergoing primary knee replacement surgery for degenerative joint disease who are suitable for early postoperative mobilization and standardized postoperative pain management protocols.
Key inclusion criteria (5 listed)
- Adult patients aged 18-80 years
- Scheduled for elective unilateral total knee arthroplasty
- Surgery performed under spinal anesthesia
- American Society of Anesthesiologists (ASA) physical status I-III
- Ability to understand the study procedures and provide informed consent
Key exclusion criteria (8 listed)
- Refusal to participate
- Contraindications to spinal anesthesia or peripheral nerve block
- Known allergy to local anesthetics
- Chronic opioid use or opioid dependence
- Preexisting neurological or neuromuscular disorders affecting lower extremities
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 |
|---|---|---|
| Fascia Iliaca Plane BlockUltrasound-guided fascia iliaca plane block is performed under sterile conditions prior to surgery as part of perioperative analgesia. Using an in-plane technique with a high-frequency linear ultrasound probe, the needle is advanced beneath the fascia iliaca, and 40 mL of 0.25% bupivacaine is injected incrementally after negative aspiration to achieve spread within the fascia iliaca compartment. | Procedure or surgery | Fascia Iliaca Plane Block |
| Adductor Canal Block + IPACK BlockAn ultrasound-guided adductor canal block followed by an interspace between the popliteal artery and capsule of the knee (IPACK) block is performed prior to surgery as part of perioperative analgesia. The adductor canal block is administered using 20 mL of 0.25% bupivacaine injected adjacent to the femoral artery beneath the sartorius muscle. Subsequently, the IPACK block is performed with 20 mL of 0.25% bupivacaine injected into the tissue plane between the popliteal artery and the posterior capsule of the knee under ultrasound guidance. | Procedure or surgery | Adductor Canal + IPACK Block |
Primary outcome
Total Postoperative Opioid Consumption
Time frame: Within the first 24 hours after surgery
Total opioid consumption administered via patient-controlled analgesia (PCA) during the first 24 hours following total knee arthroplasty. Opioid use is recorded as the cumulative dose of morphine (mg) delivered by the PCA device.
2 secondary outcomes
Postoperative Pain Intensity (NRS Score)
Time frame: 0, 2, 6, 12, and 24 hours after surgery
Early Mobilization Performance
Time frame: 24 hours after 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 3 Mar 2026.
- Background: PubMed 34653576Mou P, Wang D, Tang XM, Zeng WN, Zeng Y, Yang J, Zhou ZK. Adductor Canal Block Combined With IPACK Block for Postoperative Analgesia and Function Recovery Following Total Knee Arthroplasty: A Prospective, Double-Blind, Randomized Controlled Study. J Arthroplasty. 2022 Feb;37(2):259-266. doi: 10.1016/j.arth.2021.10.004. Epub 2021 Oct 13.
- Background: PubMed 35157136Et T, Korkusuz M, Basaran B, Yarimoglu R, Toprak H, Bilge A, Kumru N, Dedeli I. Comparison of iPACK and periarticular block with adductor block alone after total knee arthroplasty: a randomized clinical trial. J Anesth. 2022 Apr;36(2):276-286. doi: 10.1007/s00540-022-03047-6. Epub 2022 Feb 14.
- Background: PubMed 32694032Kertkiatkachorn W, Kampitak W, Tanavalee A, Ngarmukos S. Adductor Canal Block Combined With iPACK (Interspace Between the Popliteal Artery and the Capsule of the Posterior Knee) Block vs Periarticular Injection for Analgesia After Total Knee Arthroplasty: A Randomized Noninferiority Trial. J Arthroplasty. 2021 Jan;36(1):122-129.e1. doi: 10.1016/j.arth.2020.06.086. Epub 2020 Jul 2.
- Individual participant dataSharing planned: No. Individual participant data collected during this study will not be made publicly available. De-identified data may be shared upon reasonable request to the corresponding author, subject to institutional approval and applicable ethical and legal regulations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arthropathy of Knee and Early Ambulation, run by Dr Abdurrahman Yurtaslan Ankara Oncology 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 5 inclusion and 8 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 3 Mar 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?
Total Postoperative Opioid Consumption (time frame: Within the first 24 hours after surgery). 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 NCT07442123, which also lists 3 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 3 Mar 2026.