- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT04419701
Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration in Knee Arthroplasty
Comparison of Ultrasound Guided Genicular Nerve Block and Periarticular Infiltration for Postoperative Pain in Knee Arthroplasty
Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction.
The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Total knee arthroplasty (TKA), one of the most commonly performed operations in orthopaedic department, has been a successful intervention for patients with end-stage knee arthritis.
Rehabilitation after total knee arthroplasty (TKA) routinely starts immediately after surgery on the postoperative ward and therefore requires adequate analgesia. An ideal analgesic modality for post-TKA rehabilitation should permit adequate knee flexion with minimal pain without motor impairment, resulting in successful mobilization. Pain control plays an essential role in the overall postoperative period for the patients undergoing TKA.
Effective pain relief allows the patients to obtain early knee mobilization and optimal rehabilitation and thus improves the patient satisfaction.
The aim of perioperative pain control is to minimize delays in recovery, postoperative delirium and pain-related stress responses that can lead to serious morbidity and poor outcomes. Numerous approaches to effectively control postoperative pain in TKA patients have been evaluated, as poorly controlled acute postoperative pain can be associated with persistent pain. Furthermore, increased pain intensity after surgery on the second knee seems to be closely associated with chronic post-TKA pain, with similar mechanisms underlying hyperalgesia or chronic pain.
Traditionally, the degree of knee flexion has been used as an outcome measure after TKA to evaluate functional recovery and the success of the type of analgesia used.
Several methods such as intravenous opioids, extraarticular and intraarticular injection, epidural analgesia and femoral or sciatic nerve blocks are currently used for postoperative pain management.
However, each method is reported with potential side effects, for example, opioid drugs caused vomiting, nausea, constipation, dizziness and urinary retention, epidural analgesia with urinary retention, respiratory depression and spinal headache, femoral or sciatic block with diminished muscle control and possible nerve damage.
Periarticular multimodal drug injection in TKA is a technique that patients received intraoperative drug injection in the periarticular fields such as posterior capsule, medial and lateral collateral ligaments, quadriceps mechanism and peripatellar tissue at the end of the surgery. Multimodal drugs mainly consist of local anaesthetics, non-steroidal anti-inflammatory drugs, opioids, epinephrine with or without corticosteroid.
Genicular nerve block (GNB) and ablation have been used for managing chronic pain from knee osteoarthritis with good success.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
El Gharbyia
-
Tanta, El Gharbyia, Egypt, 31527
- Tarek Abdel Hay
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- unilateral knee arthroplasty surgery,
- aged more than 50 years of both genders.
- have american society of anesthesiologist physical status I-II and III.
Exclusion Criteria:
- Revision knee arthroplasty,
- previous surgery or trauma to knee,
- drug allergy, regular narcotic use,
- renal impairments
- hepatic impairments,
- neuromuscular diseases
- coagulopathy disorders.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: periarticular infiltration group
will receive intraoperative periarticular infitration consisting of 89.5 mL of normal saline, 20 mL of 5% bupivacaine and 0.5 mL of adrenaline (4.5 ugm/ml) with a concentration 1:220000 (total volume: 110 mL)
|
The cocktail will be injected at the following 7 anatomical zones as follows: Zone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement. |
|
Experimentální: genicular nerve block group
will receive ultrasound guided genicular nerve block at three nerves, i.e., superomedial, superolateral, and inferomedial genicular nerves consisting of 15 ml bupivacaine 0.25% with adrenaline 2.5 µg/ml with a concentration 1:400000 in the immediate postoperative period.
|
The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound.
genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
total doses of postoperative opioid consumption
Časové okno: postoperative first day
|
total doses of postoperative rescue morphine consumption
|
postoperative first day
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time of the first dose of rescue analgesia
Časové okno: postoperative first day
|
Time of the first dose of rescue morphine analgesia at dose of 3 mg
|
postoperative first day
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Knee range of motion
Časové okno: postoperative first day
|
The knee primarily only moves in one plane of movement, flexion and extension.
A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
|
postoperative first day
|
|
Knee range of motion
Časové okno: postoperative second day
|
The knee primarily only moves in one plane of movement, flexion and extension.
A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
|
postoperative second day
|
|
Knee range of motion
Časové okno: postoperative third day
|
The knee primarily only moves in one plane of movement, flexion and extension.
A completely straight knee joint will measure 0° and a fully bent knee will have a flexion of at 135° degrees
|
postoperative third day
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
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
Další relevantní podmínky MeSH
Další identifikační čísla studie
- pain in knee arthroplasty
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Pooperační bolest
-
Liu JiuhongDokončenoRebound Pain | Lipozomální bupivakainČína
-
University of VirginiaZatím nenabírámeArtroplastika ramene | Interscalene Block | Rebound PainSpojené státy
-
Karaman Training and Research HospitalDokončeno
-
Ajou University School of MedicineNábor
-
Beijing Sport UniversityZatím nenabírámePatellofemoral Pain, PFP
-
Beijing Sport UniversityZatím nenabíráme
-
Istanbul University - CerrahpasaNáborPatellofemoral Pain, PFPTurecko (Türkiye)
-
Pamukkale UniversityZatím nenabírámePatellofemoral Pain, PFPTurecko (Türkiye)
-
Beijing Sport UniversityDokončenoPatellofemoral Pain, PFPČína
-
The First Affiliated Hospital of Xiamen UniversityNáborRebound Pain | Artroskopická operace kolena | OliceridinČína
Klinické studie na periarticular infiltration
-
Selcuk UniversityZatím nenabírámeExtravazace | Infiltrace periferní IV terapieTurecko (Türkiye)
-
Inonu UniversityAktivní, ne náborHypomineralizace molárních řezákůTurecko (Türkiye)
-
Istanbul Medipol University HospitalNáborAkutní pooperační bolest | Laparoskopická oprava tříselné kýlyKrocan
-
Fabio GarofaloDokončenoBolest, pooperační | Kandidát na bariatrickou chirurgiiŠvýcarsko
-
Ege UniversityAktivní, ne náborZubní kaz | Demineralizace zubů | Zubní kaz na hladkém povrchu Omezeno na sklovinu | Stomatologie, Operativ | Testy aktivity zubního kazu | KariogramKrocan