Pain, JointNCT06065878
Comparison Of The Analgesic Efficacy Of IPACK (Interspace Between The Popliteal Artery And Capsule Of The Posterior Knee) Block Alone And IPACK Block Combined With Genicular Block In Patients Planned For Total Knee Arthroplasty
A study testing IPACK + Genicular Nerve Block in people with Pain, Joint and Knee Arthropathy, run by Cenk Gacemer at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Joint, Knee Arthropathy, Anesthesia
- What is being tested?
- IPACK + Genicular Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2022to 1 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- Unilateral total knee arthroplasty
- Between the ages of 18 and 80,
- Classified as American Society of Anesthesiologists (ASA) class I-III
Who cannot join
- Patients under 18 years old or over 80
- ASA scores IV and above,
- pregnant or suspected of being pregnant,
- allergic to local anesthetics,
- coagulopathy,
- injection site infection,
Show all 9Show fewer
- significant neurological or psychiatric disorders,
- severe cardiovascular diseases,
- chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
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 .
The genicular nerves, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve, comprise the five main innervation branches of the knee. Clinically, they play an important role in the anterior sensory innervation of the knee.
In the study, the investigators aimed to prospectively, double-blind, and randomly compare the postoperative analgesic efficacy of combined IPACK block and genicular block with the sole application of IPACK block in patients undergoing total knee arthroplasty (TKA). The investigators hypothesized that in blocks performed with equal volumes, there might be a spread of the local anesthetic solution from the IPACK block area to the genicular block area, and the investigators investigated this hypothesis.
Read the detailed description
Chronic knee pain, observed in the range of 7-33% in the society, is often caused by osteoarthritis. The knee joint consists of four bones: the femur, tibia, the largest sesamoid bone called the patella, and the fibula, although it does not directly join the joint. It is divided into three compartments called the medial tibiofemoral, lateral tibiofemoral, and patellofemoral, which share a common synovial cavity. Additionally, the knee joint is composed of the patellofemoral and tibiofemoral joints. The knee joint is supported by ligaments that provide stability and muscles and tendons that maintain its dynamic structure.
The superomedial quarter of the anteromedial aspect of the knee joint is innervated by the nervus vastus medialis, the medial branch of the nervus vastus intermedius, and the superior medial genicular nerve. The inferomedial quarter is innervated by the infrapatellar branch of the saphenous nerve and the inferior medial genicular nerve. The superolateral quarter of the anterolateral aspect is innervated by the nervus vastus lateralis, the lateral branch of the nervus vastus intermedius, the superior lateral genicular nerve, and the articular branches of the common fibular nerve. The inferolateral portion is innervated by the inferior lateral genicular nerve and the recurrent fibular nerve. The posterior sensation of the knee is provided by the popliteal plexus. Due to the dense innervation of the knee joint, approximately 60% of patients undergoing knee prostheses experience severe pain, while 30% describe a moderate level of pain.
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 .
The genicular nerves, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve, comprise the five main innervation branches of the knee. Clinically, they play an important role in the anterior sensory innervation of the knee. GNB (genicular nerve block) and radiofrequency ablation techniques are utilized in the treatment of chronic osteoarthritis and have recently gained popularity in postoperative pain management following knee surgeries.
In our study, the investigators aimed to prospectively, double-blind, and randomly compare the postoperative analgesic efficacy of combined IPACK block and genicular block with the sole application of IPACK block in patients undergoing total knee arthroplasty (TKA). The investigators hypothesized that in blocks performed with equal volumes, there might be a spread of the local anesthetic solution from the IPACK block area to the genicular block area, and the investigators investigated this hypothesis.
- Conditions
- Pain, Joint, Knee Arthropathy, Anesthesia, Orthopedic Disorder
- Being tested
- IPACK + Genicular Nerve Block
- Keywords
- IPACK Block, Genicular Nerve Block, Total Knee Arthroplasty
- Medical subject headings
- Arthralgia, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPACK + Genicular Nerve BlockProcedure or surgery
IPACK and Genicular Nerve block were applied with the same total volume of local anesthetic as the control group.
| Study group | Role | What they receive |
|---|---|---|
| IPACK block | No intervention | In the IPACK block group, a 20 mL solution containing 50 mg of 0.25% bupivacaine (Buvicaine®, Polifarma, Tekirdağ, Turkey) and 8 mg of dexamethasone (Dekort®, Deva, Istanbul, Turkey) was infiltrated between the popliteal artery and femur, starting 2 cm distal to the popliteal artery and being withdrawn while infiltrating proximally. |
| IPACK + Genicular Nerve Block | Active comparator | In the IPACK+GNB group, 12 mL of the same solution was used for the IPACK block infiltration. Then, the patient was positioned supine, and an ultrasound (Logiq e®, GE, Boston, USA) linear probe was placed approximately 2-3 cm above the patella, in the midline of the femur, with a sagittal plane angle of 45 degrees to visualize the femur and genicular artery . The visible needle was advanced in-plane towards the genicular artery, and 4 mL of local anesthetic solution was injected on the surface of the femur. The same procedure was repeated for the superior lateral genicular nerve block, creating a mirror image on the lateral side of the femur. Receives: Procedure: IPACK + Genicular Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores- Visual Analog Scale scores
Visual Analog Scale scores. 0 to 10 scale. 0 is no pain and 10 is the worst pain.
Measured: Postoperatively 0 minute, 30th minute , 60th minute , 2nd hour, 4th hour, 8th hour, 12th hour and 24th hour
Secondary outcomes (3)
Time to First Analgesic Requirement
the time to first rescue analgesic requirement was recorded and referred to as the analgesic time
Measured: Postoperative 24 hours
Patient and Surgeon Satisfaction- 5 point Likert scale
5 point Likert scale is from 1 to 5. 1 is Very Dissatisfied, 5 is very Satisfied.
Measured: Postoperative 24th hour.
Mobilization Time
The time elapsed until the patient could stand up and start walking with or without support was recorded as the mobilization time
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start7 Dec 2022
- Primary completion15 May 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Pain, JointStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cenk Gacemer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cenk Gacemer, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065878
- Sponsor's protocol ID
- IPACKvsIPACK&GNB
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
A. Fırat, K. Başarır, and M. Binnet, Türk Ortopedi ve Travmatoloji Birliği Derneği Diz ekleminin cerrahi anatomisi, TOTBİD Dergisi, 2011; 10 (1): 38-44
GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
PubMed 18915634Seo 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 28861197Xiumei T, Yahao L, Siwei D, Ning N. Correction: Analgesic efficacy of adding the IPACK block to multimodal analgesia protocol for primary total knee arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Dec 26;17(1):565. doi: 10.1186/s13018-022-03460-3. No abstract available.
PubMed 36572894Kukreja P, Venter A, Mason L, Kofskey AM, Northern T, Naranje S, Ghanem E, Lawson PA, Kalagara H. Comparison of Genicular Nerve Block in Combination With Adductor Canal Block in Both Primary and Revision Total Knee Arthroplasty: A Retrospective Case Series. Cureus. 2021 Jul 29;13(7):e16712. doi: 10.7759/cureus.16712. eCollection 2021 Jul.
PubMed 34471571Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.
PubMed 31407791Elsaman AM, Maaty A, Hamed A. Genicular nerve block in rheumatoid arthritis: a randomized clinical trial. Clin Rheumatol. 2021 Nov;40(11):4501-4509. doi: 10.1007/s10067-021-05821-5. Epub 2021 Jul 2.
PubMed 34213672Tran J, Giron Arango L, Peng P, Sinha SK, Agur A, Chan V. Evaluation of the iPACK block injectate spread: a cadaveric study. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100355. doi: 10.1136/rapm-2018-100355. Online ahead of print.
PubMed 31061110
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Analgesic Efficacy Of IPACK (Interspace Between The Popliteal Artery And Capsule Of The Posterior Knee) Block Alone And IPACK Block Combined With Genicular Block In Patients Planned For Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06065878
- Acronym / sponsor ID
- IPACKvsIPACK&GNB
- Conditions
- Pain, Joint, Knee Arthropathy, Anesthesia, Orthopedic Disorder
- Keywords
- IPACK Block, Genicular Nerve Block, Total Knee Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cenk GacemerUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 4 Oct 2023 (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.
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 .
The genicular nerves, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve, comprise the five main innervation branches of the knee. Clinically, they play an important role in the anterior sensory innervation of the knee.
In the study, the investigators aimed to prospectively, double-blind, and randomly compare the postoperative analgesic efficacy of combined IPACK block and genicular block with the sole application of IPACK block in patients undergoing total knee arthroplasty (TKA). The investigators hypothesized that in blocks performed with equal volumes, there might be a spread of the local anesthetic solution from the IPACK block area to the genicular block area, and the investigators investigated this hypothesis.
Detailed description
Chronic knee pain, observed in the range of 7-33% in the society, is often caused by osteoarthritis. The knee joint consists of four bones: the femur, tibia, the largest sesamoid bone called the patella, and the fibula, although it does not directly join the joint. It is divided into three compartments called the medial tibiofemoral, lateral tibiofemoral, and patellofemoral, which share a common synovial cavity. Additionally, the knee joint is composed of the patellofemoral and tibiofemoral joints. The knee joint is supported by ligaments that provide stability and muscles and tendons that maintain its dynamic structure.
The superomedial quarter of the anteromedial aspect of the knee joint is innervated by the nervus vastus medialis, the medial branch of the nervus vastus intermedius, and the superior medial genicular nerve. The inferomedial quarter is innervated by the infrapatellar branch of the saphenous nerve and the inferior medial genicular nerve. The superolateral quarter of the anterolateral aspect is innervated by the nervus vastus lateralis, the lateral branch of the nervus vastus intermedius, the superior lateral genicular nerve, and the articular branches of the common fibular nerve. The inferolateral portion is innervated by the inferior lateral genicular nerve and the recurrent fibular nerve. The posterior sensation of the knee is provided by the popliteal plexus. Due to the dense innervation of the knee joint, approximately 60% of patients undergoing knee prostheses experience severe pain, while 30% describe a moderate level of pain.
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 .
The genicular nerves, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve, comprise the five main innervation branches of the knee. Clinically, they play an important role in the anterior sensory innervation of the knee. GNB (genicular nerve block) and radiofrequency ablation techniques are utilized in the treatment of chronic osteoarthritis and have recently gained popularity in postoperative pain management following knee surgeries.
In our study, the investigators aimed to prospectively, double-blind, and randomly compare the postoperative analgesic efficacy of combined IPACK block and genicular block with the sole application of IPACK block in patients undergoing total knee arthroplasty (TKA). The investigators hypothesized that in blocks performed with equal volumes, there might be a spread of the local anesthetic solution from the IPACK block area to the genicular block area, and the investigators investigated this hypothesis.
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 |
|---|---|---|
| IPACK block | No intervention | –In the IPACK block group, a 20 mL solution containing 50 mg of 0.25% bupivacaine (Buvicaine®, Polifarma, Tekirdağ, Turkey) and 8 mg of dexamethasone (Dekort®, Deva, Istanbul, Turkey) was infiltrated between the popliteal artery and femur, starting 2 cm distal to the popliteal artery and being withdrawn while infiltrating proximally. |
| IPACK + Genicular Nerve Block | Active comparator | Procedure: IPACK + Genicular Nerve BlockIn the IPACK+GNB group, 12 mL of the same solution was used for the IPACK block infiltration. Then, the patient was positioned supine, and an ultrasound (Logiq e®, GE, Boston, USA) linear probe was placed approximately 2-3 cm above the patella, in the midline of the femur, with a sagittal plane angle of 45 degrees to visualize the femur and genicular artery . The visible needle was advanced in-plane towards the genicular artery, and 4 mL of local anesthetic solution was injected on the surface of the femur. The same procedure was repeated for the superior lateral genicular nerve block, creating a mirror image on the lateral side of the femur. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral total knee arthroplasty
- Between the ages of 18 and 80,
- Classified as American Society of Anesthesiologists (ASA) class I-III
Key exclusion criteria (9 listed)
- Patients under 18 years old or over 80
- ASA scores IV and above,
- pregnant or suspected of being pregnant,
- allergic to local anesthetics,
- coagulopathy,
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 + Genicular Nerve BlockIPACK and Genicular Nerve block were applied with the same total volume of local anesthetic as the control group. | Procedure or surgery | IPACK + Genicular Nerve Block |
Primary outcome
Pain Scores- Visual Analog Scale scores
Time frame: Postoperatively 0 minute, 30th minute , 60th minute , 2nd hour, 4th hour, 8th hour, 12th hour and 24th hour
Visual Analog Scale scores. 0 to 10 scale. 0 is no pain and 10 is the worst pain.
3 secondary outcomes
Time to First Analgesic Requirement
Time frame: Postoperative 24 hours
Patient and Surgeon Satisfaction- 5 point Likert scale
Time frame: Postoperative 24th hour.
Mobilization Time
Time frame: Postoperative 24 hours
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 4 Oct 2023.
- BackgroundA. Fırat, K. Başarır, and M. Binnet, Türk Ortopedi ve Travmatoloji Birliği Derneği Diz ekleminin cerrahi anatomisi, TOTBİD Dergisi, 2011; 10 (1): 38-44
- Background: PubMed 18915634GARDNER E. The innervation of the knee joint. Anat Rec. 1948 May;101(1):109-30. doi: 10.1002/ar.1091010111. No abstract available.
- 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.
- Background: PubMed 36572894Xiumei T, Yahao L, Siwei D, Ning N. Correction: Analgesic efficacy of adding the IPACK block to multimodal analgesia protocol for primary total knee arthroplasty: a meta-analysis of randomized controlled trials. J Orthop Surg Res. 2022 Dec 26;17(1):565. doi: 10.1186/s13018-022-03460-3. No abstract available.
- Background: PubMed 34471571Kukreja P, Venter A, Mason L, Kofskey AM, Northern T, Naranje S, Ghanem E, Lawson PA, Kalagara H. Comparison of Genicular Nerve Block in Combination With Adductor Canal Block in Both Primary and Revision Total Knee Arthroplasty: A Retrospective Case Series. Cureus. 2021 Jul 29;13(7):e16712. doi: 10.7759/cureus.16712. eCollection 2021 Jul.
- Background: PubMed 31407791Roberts SL, Stout A, Dreyfuss P. Review of Knee Joint Innervation: Implications for Diagnostic Blocks and Radiofrequency Ablation. Pain Med. 2020 May 1;21(5):922-938. doi: 10.1093/pm/pnz189.
- Background: PubMed 34213672Elsaman AM, Maaty A, Hamed A. Genicular nerve block in rheumatoid arthritis: a randomized clinical trial. Clin Rheumatol. 2021 Nov;40(11):4501-4509. doi: 10.1007/s10067-021-05821-5. Epub 2021 Jul 2.
- Background: PubMed 31061110Tran J, Giron Arango L, Peng P, Sinha SK, Agur A, Chan V. Evaluation of the iPACK block injectate spread: a cadaveric study. Reg Anesth Pain Med. 2019 May 6:rapm-2018-100355. doi: 10.1136/rapm-2018-100355. Online ahead of print.
- Individual participant dataSharing planned: No
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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?
A study testing IPACK + Genicular Nerve Block in people with Pain, Joint and Knee Arthropathy, run by Cenk Gacemer 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 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 4 Oct 2023. 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?
Pain Scores- Visual Analog Scale scores (time frame: Postoperatively 0 minute, 30th minute , 60th minute , 2nd hour, 4th hour, 8th hour, 12th hour and 24th hour). 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 NCT06065878, which also lists 8 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 4 Oct 2023.