Clinical trial NCT06864663: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nerve Block
Regional Anaesthesia
Keywords: adductor canal block
interspace between popliteal artery and capsule of knee
knee arthroplasty
genicular nerve block
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled interventional prospective study
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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

Eligibility criteria: Inclusion Criteria:

1. Patients American Society of anesthesiologists' physical status (ASA) I to III.
2. Aged 18 to 70 years.
3. Both sexes.
4. Patients scheduled for total knee arthroplasty.

Exclusion Criteria:

1. Patient refusal
2. ASA physical status IV or more.
3. Patients with known allergy to any of the study drugs.
4. Infection at the site of injection.
5. Patients with neuromuscular disease.
6. Presence of any coagulopathy.
7. Patients with history of any psychiatric or cognitive disorder.
8. patient with previous knee surgery.
9. BMI more than 40 kg/m2.

Primary outcomes:
measure: individual visual analog pain scores at 0, 6, 12 , 24 and 48 h postoperatively
timeFrame: 48 hours
Secondary outcomes:
measure: time to first reported pain and first analgesic request during post-anesthesia care unit stay
timeFrame: 48 hours
measure: Analgesic consumption during the first 48 h post-surgery
timeFrame: 48 hours
measure: Quadriceps muscle strength
timeFrame: 24 hours
measure: The sensorimotor functions of the tibial nerve and common peroneal nerve (CPN) will be evaluated using a 3-point scale
timeFrame: 8 hours postoperative
measure: Ambulation and mobilization ability
timeFrame: 48 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
References:
citation: 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.
citation: Padhy 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.
citation: Gonzalez 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.
citation: Mu 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.