- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07588958
Genicular Nerve Versus Adductor Canal Block for Postoperative Analgesia
Genicular Nerve Versus Adductor Canal Block for Postoperative Analgesia in Patients Undergoing Total Knee Arthroplasty
Severe postoperative pain following total knee arthroplasty (TKA ) has been shown to negatively affect early mobilization, physical rehabilitation, time to discharge, and overall post-operative recovery.Therefore, reducing postoperative pain and early mobilization has become critical in reducing early mortality, preventing future chronic pain, and limiting the use of opioids The adductor canal block (ACB) has been found to be an excellent alternative to the FNB, providing adequate analgesia to the anterior knee compartment while enabling an improved postoperative range of motion by sparing motor branches to the quadriceps muscles . However, patients do not achieve adequate posterior knee analgesia as ACB pain relief is primarily limited to the anterior capsule of the knee.
Genicular nerve block (GNB) and radiofrequency ablation of genicular nerves (RFGN) were originally introduced by Choi et al. as a therapeutic alternative for chronic knee OA and were quickly adopted for use in patients undergoing TKA due to the significant pain reduction and functional improvement observed in these patients . GNBs target five main innervating branches of the knee, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve.
Přehled studie
Postavení
Detailní popis
Chronic knee osteoarthritis (OA), an epidemic among aging populations, is a leading source of chronic pain in the United States and other developed countries . The rise in prevalence of knee OA is a direct result of factors including longer life expectancy and increased body mass index (BMI). It has been reported that at least 19% of American adults aged 45 years and older are affected . Severe postoperative pain following total knee arthroplasty (TKA ) has been shown to negatively affect early mobilization, physical rehabilitation, time to discharge, and overall post-op recovery
.Therefore, reducing postoperative pain and early mobilization has become critical in reducing early mortality, preventing future chronic pain, and limiting the use of opioids . Balancing pain control with patient ambulation often proves to be a challenge due to both the motor blocking effects of many proximal nerve blocks and the often inadequate analgesia associated with more superficial periarticular injections . Therefore, numerous modalities of analgesic treatment combining different methods of nerve blockade for effective postoperative analgesia and faster functional recovery have been discussed . However, the superior technique is yet to be
determined. Successful postoperative analgesia for TKA requires careful consideration of knee innervation, with an emphasis placed on branches of the femoral nerve innervating the anterior and medical aspects of the knee and branches of the sciatic nerve innervating the posterior aspects of the knee capsule . In the context of nerve blockade, femoral nerve block (FNB) has traditionally been a critical component in the multimodal management of pain in TKA patients due to the high analgesic efficacy and the minimal risks associated. However, FNB is associated with decreased quadriceps motor strength leading to limited physical therapy (PT) participation, delayed ambulation, and discharge . The adductor canal block (ACB) has been found to be an excellent alternative to the FNB, providing adequate analgesia to the anterior knee compartment while enabling an improved postoperative range of motion by sparing motor branches to the quadriceps muscles . However, patients do not achieve adequate posterior knee analgesia as ACB pain relief is primarily limited to the anterior capsule of the knee.
Genicular nerve block (GNB) and radiofrequency ablation of genicular nerves (RFGN) were originally introduced by Choi et al. as a therapeutic alternative for chronic knee OA and were quickly adopted for use in patients undergoing TKA due to the significant pain reduction and functional improvement observed in these patients . GNBs target five main innervating branches of the knee, including the superomedial, inferomedial, superolateral, inferolateral genicular nerves, and the infrapatellar branch of the saphenous nerve. Several bony landmarks surrounding these nerves aid in proper needle placement under fluoroscopic guidance . The GNB has a motor-sparing effect that is desirable for early ambulation postoperatively, better PT, and earlier discharge .
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Alsharqia
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Zagazig, Alsharqia, Egypt, 4115
- Faculty of Medicine - Zagazig University
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Patient acceptance.
- Sex: both; male and female.
- Age: over 65 years old.
- American society of anesthesiologists (ASA): II .
- Body mass index (BMI) less than 35 kg/m2.
- Operation : elective unilateral TKA.
- Duration of surgery : 2-3 hours.
Exclusion Criteria:
- History of allergy to local anesthetics (lidocaine or bupivicaine).
- Coexisting hematologic disorders or malnourished patient.
- Pre-existing major organ dysfunction including hepatic or renal failure, and left ventricular ejection fraction <30%
- Peripheral neuropathy.
- Patients with a diagnosis of cognitive impairment or significant psychiatric illness.
- Skin infection at site of block.
- Contraindication to spinal anesthesia as coagulopathy and infection at site of injection.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Jiný: control group
Receive spinal anesthesia
|
spinal anesthesia will be given (under complete aseptic conditions) at the level of L3/4 while the patient in the sitting position using a spinal needle 25 G x 3.5 inches with injection of hyperbaric bupivacaine 0.5% 3ml plus fentanyl 25 microgram .
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Aktivní komparátor: Genicular nerve block group
Receive Genicular Nerve Block
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For the superomedial genicular nerve, a linear transducer will be placed along the longitudinal plane of the femur to visualize vastus medialis, the distal femur, and the genicular artery. Using an in-plane technique, a 10-cm echogenic 21-gauge needle will be advanced in the cephalad to the caudad direction until the needle contacted femoral shaft, just cephalad to the genicular artery, and 5 ml of 0.25% bupivacaine will be injected to spread along the femoral periosteum. This same technique, using 5 ml of 0.25% bupivacaine, will be used in a mirror image on the lateral epicondyle to block the superolateral genicular nerve. To target the inferomedial genicular nerve, a linear transducer will be placed in the sagittal plane on the anterior medial tibia. |
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Aktivní komparátor: Adductor canal block group
Receive Adductor canal block
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The transducer will be placed anteromedially midway between inguinal crease and medial condyle to identify sartorius muscle.
Probe will be positioned perpendicular to the femoral artery and using in-plane technique with needle directed from lateral to medial to deposit local anesthetic under sartorius and around the femoral artery.
15ml bupivacaine 0.25% will be injected
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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changes of pain assessment
Časové okno: time frame ( at PACU, 2 hours (h ) , 4 , 8 , 12 , 16 , 24 hours postoperatively )
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visual analogue scale
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time frame ( at PACU, 2 hours (h ) , 4 , 8 , 12 , 16 , 24 hours postoperatively )
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Modified Bromage scale
Časové okno: at PACU, 3 hours and 6 hours postoperatively
|
no motor nerveblock in the lower extremity = 0 point; the affected limb cannot lift the leg = 1 point; failure to bend the knee of the affected limb = 2 points; and failure to bend the ankle = 3points
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at PACU, 3 hours and 6 hours postoperatively
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Soha Saad mohamed Hassouna, PHD, Faculty of Medicine - Zagazig University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Organické chemikálie
- Heterocyklické sloučeniny, 1 kruh
- Heterocyklické sloučeniny
- Anilides
- Amidy
- Anilinové sloučeniny
- Aminy
- Piperidiny
- Socioekonomické faktory
- Charakteristiky populace
- Anestezie a analgezie
- Demografie
- Anestezie, vedení
- Anestézie
- Rodinné charakteristiky
- Rodinný stav
- Bupivakain
- Fentanyl
- Anestezie, páteř
- Svobodná osoba
Další identifikační čísla studie
- 10793-14/5-2023
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení IPD
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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