Nerve BlockNCT06864663
A Comparative Study of Combined Adductor Canal and Interspace Between Popliteal Artery and Knee Capsule Versus Combined Adductor Canal and Genicular Nerve in Total Knee Arthroplasty
A study testing nerve block with bupivacaine 0.25% in people with Nerve Block and Regional Anaesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The aim of this study is to investigate the effectiveness of combined adductor canal block (ACB) with interspace between popliteal artery and the knee capsule (IPACK) versus combined ACB with genicular nerve block (GNB) for providing analgesia in knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nerve Block, Regional Anaesthesia
- What is being tested?
- nerve block with bupivacaine 0.25%
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2025to 15 Oct 2025
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients American Society of anesthesiologists' physical status (ASA) I to III.
- Aged 18 to 70 years.
- Both sexes.
- Patients scheduled for total knee arthroplasty.
Who cannot join
- Patient refusal
- ASA physical status IV or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with neuromuscular disease.
- Presence of any coagulopathy.
Show all 9Show fewer
- Patients with history of any psychiatric or cognitive disorder.
- patient with previous knee surgery.
- BMI more than 40 kg/m2.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain Shams University
Cairo
Ahmed Fathy, +201204465766, drfathy_83@yahoo.com
About this study
Official title: A Comparative Study of Combined Ultrasound-Guided Adductor Canal Block and Interspace Between the Popliteal Artery and Capsule of the Knee (IPACK) Versus Combined Adductor Canal Block and Genicular Nerve Block Following Total Knee Arthroplasty
The aim of this study is to investigate the effectiveness of combined adductor canal block (ACB) with interspace between popliteal artery and the knee capsule (IPACK) versus combined ACB with genicular nerve block (GNB) for providing analgesia in knee arthroplasty. The investigators hypothesize that the analgesic efficacy of ACB combined with GNB will be non-inferior to that of ACB combined with IPACK. Additionally, the investigators aim to assess whether the combination of ACB and GNB results in a significantly lower occurrence of sensory or motor block affecting the tibial and common peroneal nerves compared to ACB and IPACK
Read the detailed description
Spinal anesthesia will be chosen as the main anesthetic technique by injecting 3-3.5 ml of hyperbaric bupivacaine 0.5% by 24 G pencil-point needle at lumbar (L2-L3) or (L3-L4) space with 25 ug of fentanyl as adjuvant while patient is in setting position.
In both groups, the adductor canal block (ACB) will be performed with the patient in a supine position, the operative limb externally rotated, and the knee slightly flexed. A high-frequency ultrasound probe (10-15 MHz) will be positioned at the mid-thigh, at the midpoint of the line connecting the patella to the anterior superior iliac spine.
During the procedure, the following structures will be identified: the femoral artery, femoral vein, sartorius muscle, vastus medialis, and adductor longus. The hyperechoic appearance of the saphenous nerve will be visualized lateral to the femoral artery. Using an in-plane technique, 15 mL of 0.25% bupivacaine will be injected to achieve effective analgesia.
For (Group A) To perform the interspace between popliteal artery and knee capsule (IPACK) block, a curvilinear ultrasound probe (2-5 MHz) will first be positioned on the lower third of the medial thigh to identify the femoral vessels. The transducer will then be moved caudally into the popliteal fossa, allowing visualization of the femoral artery as it transitions into the popliteal artery. With the knee flexed at 90°, the needle will be advanced using an in-plane ultrasound-guided technique. The needle trajectory will be from medial to lateral, targeting the space between the popliteal vessels and the posterior capsule of the knee joint. Once the needle tip is positioned approximately 2 cm beyond the lateral border of the popliteal artery, an injection of 15 mL of 0.25% bupivacaine will be administered into this interspace.
For (Group B), The genicular nerve block (GNB) will target three peri-knee nerve branches: the superior medial genicular nerve (SMGN), inferior medial genicular nerve (IMGN), and superior lateral genicular nerve (SLGN). Each nerve will receive an injection of 5 mL of 0.25% bupivacaine.
For SMGN block the high frequency ultrasound probe will be placed laterally over the medial supracondylar area of the femur to identify the SMGN near the superior medial genicular artery, followed by injection adjacent to the artery. For the IMGN, the probe will be positioned over the medial condyle of the tibia to locate the inferior medial genicular artery near the neck of the tibia, again injecting adjacent to the artery. Finally, the SLGN will be targeted by placing the probe over the lateral condyle of the femur to find the superior lateral genicular artery, with the local anesthetic injected nearby.
The investigators will omit the inferolateral genicular nerve (ILGN) block to prevent any unwanted motor weakness or the potential for foot drop that may occur from inadvertently blocking branches of the common peroneal nerve. This decision aligns with the goal of optimizing analgesia while minimizing the risk of motor deficits, ensuring a safer and more effective postoperative recovery for patients undergoing knee arthroplasty.
In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities
- Conditions
- Nerve Block, Regional Anaesthesia
- Being tested
- nerve block with bupivacaine 0.25%
- Keywords
- adductor canal block, interspace between popliteal artery and capsule of knee, knee arthroplasty, genicular nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nerve block with bupivacaine 0.25%Drug
ultrasound guided adductor canal block and interspace between the popliteal artery and the knee capsule using bupivacaine 0.25%
Nerve Block with bupivacaine 0.25%Drug
ultrasound guided combined adductor canal block and genicular nerve block using bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving combined ACB and IPACK blocks | Active comparator | ultrasound guided block of saphenous nerve in adductor canal and block of articular branches of knee between the popliteal artery and the knee capsule (IPACK) Receives: Drug: Nerve Block with bupivacaine 0.25% |
| Patients receiving combined ACB and GNB | Active comparator | ultrasound guided block of saphenous nerve in adductor canal and block of the three peri-knee nerve branches: the superior medial genicular nerve (SMGN), inferior medial genicular nerve (IMGN), and superior lateral genicular nerve (SLGN) Receives: Drug: nerve block with bupivacaine 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
individual visual analog pain scores at 0, 6, 12 , 24 and 48 h postoperatively
(VAS; 0 = no pain and 10 = worst pain imaginable)
Measured: 48 hours
Secondary outcomes (5)
time to first reported pain and first analgesic request during post-anesthesia care unit stay
reported time in minutes
Measured: 48 hours
Analgesic consumption during the first 48 h post-surgery
Converted to IV pethidine equivalents. The analgesic dose of pethidine will be 0.5 mg/kg/dose to be repeated on demand
Measured: 48 hours
Quadriceps muscle strength
will be measured using the Straight Leg Raise (SLR) test, which will be conducted preoperatively and again 24 hours postoperatively. The SLR will be scored on a scale from 0 to 5, where 0 indicates no voluntary contraction, 1 signifies muscle flicker without limb movement, 2 represents active movement with gravity eliminated, 3 indicates movement against gravity but without resistance, 4 denotes movement against some resistance, and 5 reflects normal motor strength against resistance.
Measured: 24 hours
The sensorimotor functions of the tibial nerve and common peroneal nerve (CPN) will be evaluated using a 3-point scale
For sensory function, the scale will be as follows: 0 indicates normal sensation, 1 signifies lack of cold perception but intact touch sensation, and 2 denotes absence of touch sensation. For motor function, the scale will be: 0 for normal motor function, 1 for deficient motor function, and 2 for no motor function.
Measured: 8 hours postoperative
Ambulation and mobilization ability
Assessed using the Timed Up and Go (TUG) test
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start15 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion15 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled interventional prospective study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864663
- Sponsor's protocol ID
- R313/2024
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Kukreja 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 34471571Padhy S, Patki AY, Kar AK, Durga P, Sireesha L. Comparison of sensory posterior articular nerves of the knee (SPANK) block versus infiltration between the popliteal artery and the capsule of the knee (IPACK) block when added to adductor canal block for pain control and knee rehabilitation after total knee arthroplasty---A prospective randomised trial. Indian J Anaesth. 2021 Nov;65(11):792-797. doi: 10.4103/ija.ija_682_21. Epub 2021 Nov 23.
PubMed 35001951Gonzalez Sotelo V, Macule F, Minguell J, Berge R, Franco C, Sala-Blanch X. Ultrasound-guided genicular nerve block for pain control after total knee replacement: Preliminary case series and technical note. Rev Esp Anestesiol Reanim. 2017 Dec;64(10):568-576. doi: 10.1016/j.redar.2017.04.001. Epub 2017 May 26. English, Spanish.
PubMed 28554709Mu T, Yuan B, Wei K, Yang Q. Adductor canal block combined with genicular nerve block versus local infiltration analgesia for total knee arthroplasty: a randomized noninferiority trial. J Orthop Surg Res. 2024 Sep 6;19(1):546. doi: 10.1186/s13018-024-05048-5.
PubMed 39238029
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Combined Ultrasound-Guided Adductor Canal Block and Interspace Between the Popliteal Artery and Capsule of the Knee (IPACK) Versus Combined Adductor Canal Block and Genicular Nerve Block Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT06864663
- Acronym / sponsor ID
- R313/2024
- Conditions
- Nerve Block, Regional Anaesthesia
- Keywords
- adductor canal block, interspace between popliteal artery and capsule of knee, knee arthroplasty, genicular nerve block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 15 Oct 2025 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the effectiveness of combined adductor canal block (ACB) with interspace between popliteal artery and the knee capsule (IPACK) versus combined ACB with genicular nerve block (GNB) for providing analgesia in knee arthroplasty. The investigators hypothesize that the analgesic efficacy of ACB combined with GNB will be non-inferior to that of ACB combined with IPACK. Additionally, the investigators aim to assess whether the combination of ACB and GNB results in a significantly lower occurrence of sensory or motor block affecting the tibial and common peroneal nerves compared to ACB and IPACK
Detailed description
Spinal anesthesia will be chosen as the main anesthetic technique by injecting 3-3.5 ml of hyperbaric bupivacaine 0.5% by 24 G pencil-point needle at lumbar (L2-L3) or (L3-L4) space with 25 ug of fentanyl as adjuvant while patient is in setting position.
In both groups, the adductor canal block (ACB) will be performed with the patient in a supine position, the operative limb externally rotated, and the knee slightly flexed. A high-frequency ultrasound probe (10-15 MHz) will be positioned at the mid-thigh, at the midpoint of the line connecting the patella to the anterior superior iliac spine.
During the procedure, the following structures will be identified: the femoral artery, femoral vein, sartorius muscle, vastus medialis, and adductor longus. The hyperechoic appearance of the saphenous nerve will be visualized lateral to the femoral artery. Using an in-plane technique, 15 mL of 0.25% bupivacaine will be injected to achieve effective analgesia.
For (Group A) To perform the interspace between popliteal artery and knee capsule (IPACK) block, a curvilinear ultrasound probe (2-5 MHz) will first be positioned on the lower third of the medial thigh to identify the femoral vessels. The transducer will then be moved caudally into the popliteal fossa, allowing visualization of the femoral artery as it transitions into the popliteal artery. With the knee flexed at 90°, the needle will be advanced using an in-plane ultrasound-guided technique. The needle trajectory will be from medial to lateral, targeting the space between the popliteal vessels and the posterior capsule of the knee joint. Once the needle tip is positioned approximately 2 cm beyond the lateral border of the popliteal artery, an injection of 15 mL of 0.25% bupivacaine will be administered into this interspace.
For (Group B), The genicular nerve block (GNB) will target three peri-knee nerve branches: the superior medial genicular nerve (SMGN), inferior medial genicular nerve (IMGN), and superior lateral genicular nerve (SLGN). Each nerve will receive an injection of 5 mL of 0.25% bupivacaine.
For SMGN block the high frequency ultrasound probe will be placed laterally over the medial supracondylar area of the femur to identify the SMGN near the superior medial genicular artery, followed by injection adjacent to the artery. For the IMGN, the probe will be positioned over the medial condyle of the tibia to locate the inferior medial genicular artery near the neck of the tibia, again injecting adjacent to the artery. Finally, the SLGN will be targeted by placing the probe over the lateral condyle of the femur to find the superior lateral genicular artery, with the local anesthetic injected nearby.
The investigators will omit the inferolateral genicular nerve (ILGN) block to prevent any unwanted motor weakness or the potential for foot drop that may occur from inadvertently blocking branches of the common peroneal nerve. This decision aligns with the goal of optimizing analgesia while minimizing the risk of motor deficits, ensuring a safer and more effective postoperative recovery for patients undergoing knee arthroplasty.
In postoperative period all patients will receive the same adjuvant multimodal analgesia which will be 1000 mg of paracetamol with or without 30 mg ketorolac depending on comorbidities
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled interventional prospective study
| Arm | Type | Receives |
|---|---|---|
| Patients receiving combined ACB and IPACK blocks | Active comparator | Drug: Nerve Block with bupivacaine 0.25%ultrasound guided block of saphenous nerve in adductor canal and block of articular branches of knee between the popliteal artery and the knee capsule (IPACK) |
| Patients receiving combined ACB and GNB | Active comparator | Drug: nerve block with bupivacaine 0.25%ultrasound guided block of saphenous nerve in adductor canal and block of the three peri-knee nerve branches: the superior medial genicular nerve (SMGN), inferior medial genicular nerve (IMGN), and superior lateral genicular nerve (SLGN) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients American Society of anesthesiologists' physical status (ASA) I to III.
- Aged 18 to 70 years.
- Both sexes.
- Patients scheduled for total knee arthroplasty.
Key exclusion criteria (9 listed)
- Patient refusal
- ASA physical status IV or more.
- Patients with known allergy to any of the study drugs.
- Infection at the site of injection.
- Patients with neuromuscular disease.
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 |
|---|---|---|
| nerve block with bupivacaine 0.25%ultrasound guided adductor canal block and interspace between the popliteal artery and the knee capsule using bupivacaine 0.25% | Drug | Patients receiving combined ACB and GNB |
| Nerve Block with bupivacaine 0.25%ultrasound guided combined adductor canal block and genicular nerve block using bupivacaine 0.25% | Drug | Patients receiving combined ACB and IPACK blocks |
Primary outcome
individual visual analog pain scores at 0, 6, 12 , 24 and 48 h postoperatively
Time frame: 48 hours
(VAS; 0 = no pain and 10 = worst pain imaginable)
5 secondary outcomes
time to first reported pain and first analgesic request during post-anesthesia care unit stay
Time frame: 48 hours
Analgesic consumption during the first 48 h post-surgery
Time frame: 48 hours
Quadriceps muscle strength
Time frame: 24 hours
The sensorimotor functions of the tibial nerve and common peroneal nerve (CPN) will be evaluated using a 3-point scale
Time frame: 8 hours postoperative
Ambulation and mobilization ability
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Results publication: 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.
- Results publication: PubMed 35001951Padhy S, Patki AY, Kar AK, Durga P, Sireesha L. Comparison of sensory posterior articular nerves of the knee (SPANK) block versus infiltration between the popliteal artery and the capsule of the knee (IPACK) block when added to adductor canal block for pain control and knee rehabilitation after total knee arthroplasty---A prospective randomised trial. Indian J Anaesth. 2021 Nov;65(11):792-797. doi: 10.4103/ija.ija_682_21. Epub 2021 Nov 23.
- Results publication: PubMed 28554709Gonzalez Sotelo V, Macule F, Minguell J, Berge R, Franco C, Sala-Blanch X. Ultrasound-guided genicular nerve block for pain control after total knee replacement: Preliminary case series and technical note. Rev Esp Anestesiol Reanim. 2017 Dec;64(10):568-576. doi: 10.1016/j.redar.2017.04.001. Epub 2017 May 26. English, Spanish.
- Results publication: PubMed 39238029Mu T, Yuan B, Wei K, Yang Q. Adductor canal block combined with genicular nerve block versus local infiltration analgesia for total knee arthroplasty: a randomized noninferiority trial. J Orthop Surg Res. 2024 Sep 6;19(1):546. doi: 10.1186/s13018-024-05048-5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nerve block with bupivacaine 0.25% in people with Nerve Block and Regional Anaesthesia, run by Ain Shams University at 1 site in Egypt.
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: opening soon, as of the sponsor's last update on 7 Mar 2025. 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 Egypt. 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 Ahmed Fathy (+201204465766, drfathy_83@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
individual visual analog pain scores at 0, 6, 12 , 24 and 48 h postoperatively (time frame: 48 hours). 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 NCT06864663, which also lists 4 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 7 Mar 2025.