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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07813715
Intra-Articular Adrenaline Versus Tourniquet in Knee Arthroscopy: A Cohort Study
Intra-Articular Adrenaline Versus Tourniquet in Knee Arthroscopy in a Tertiary Care Center: A Prospective Cohort Study
Arthroscopy has become one of the most commonly performed orthopaedic surgeries in the world due to it being a minimally invasive technique. Clear visualization is crucial for both safe and efficient arthroscopic procedures. Pneumatic tourniquet has been widely used in knee arthroscopic surgeries to obtain bloodless surgical field, improve visualization, and thereby surgical time. However, complications from tourniquet use are not uncommon, particularly in patients whose procedure takes longer than 60 minutes. Using a tourniquet could increase problems, such as electromyographic alterations, nerve compressions, arterial occlusions, delayed muscle recovery, and muscle weakness.
Intra-articular adrenaline injection creates a bloodless field by reducing local perfusion through its vasoconstrictive properties, mimicking the effect of a tourniquet. It appeared to be a potentially effective and safe option. Therefore, this study aimed to evaluate intra-articular adrenaline infiltration as an alternative for achieving a bloodless field without tourniquet-related side effects, in terms of clinical efficacy, operative duration and safety. We would compare intra operative visibility and safety of intra articular adrenaline (1:200,000) injections with use of a tourniquet in arthroscopic knee surgeries. Comparision is made between one group that received standard tourniquet application and another group that received intra articular adrenaline injection. Then the intraoperative visibility in these two groups is compared using tools like surgeon visual analogue score and amount of irrigation fluid required. The effectiveness and safety of the method used is compared using appropriate statistical tools.
Null Hypothesis: There is no difference in intraoperative visibility and safety during knee arthroscopic surgeries with standard tourniquet application versus intraarticular adrenaline injection.
H0: outcome in Adrenaline group =< outcome in Tourniquet group
Alternative Hypothesis: Intra articular adrenaline injection is better than tourniquet use in arthroscopic knee surgeries with respect to operative field visibility and safety.
H1: outcome in Adrenaline group > or (not less than) outcome in Tourniquet group
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Bagmati
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Dhulikhel, Bagmati, Nepal, 45200
- Dhulikhel Hospital, Kathmandu University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients who are skeletally matured (18 year and above) undergoing knee arthroscopic surgeries.
The surgeries included are:
- Anterior Cruciate Ligament reconstruction
- Anterior Cruciate Ligament repair
- Anterior Cruciate Ligament decompression
- Meniscus repair surgeries
- Meniscus resection surgeries - Patients who provide consent for the study
Exclusion Criteria:
The patient with following procedures are excluded:
- Posterior Cruciate Ligament (PCL) surgeries
- Multi-ligament surgeries
- Osteochondral or intra articular fractures
- Patients under 18 years of age
- Patients who do not provide consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Adrenaline Administration
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Both groups will be injected at portal and intra-articular with an injection solution (Group A will be infiltrated with 60 ml of normal saline only and Group B will be injected with 60 ml of 1:200,000 adrenaline diluted in 100 ml of normal saline)
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Comparador activo: Tourniquet Administration
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The tourniquet in all groups are applied over proximal thigh with well-padded cotton and inflated (only in Group A - Tourniquet Administration Group's) to 100 -150mm of Hg higher than systolic pressure of the patient.
Other group - Group B, have no inflation of tourniquet, but only applied.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative Visibility Assessed by Surgeon Visual Analogue Scale (VAS)
Periodo de tiempo: 1.5 years
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Intraoperative visibility during arthroscopic knee surgery will be assessed by the operating surgeon using a 10-point Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates excellent visibility and 10 indicates extremely poor visibility.
Lower scores indicate better operative visibility.
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1.5 years
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Intraoperative Irrigation Fluid Requirement
Periodo de tiempo: 1.5 years
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The total volume of irrigation fluid used during arthroscopic knee surgery will be recorded in milliliters (mL).
Lower irrigation fluid requirement indicates better operative visibility and efficiency.
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1.5 years
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- Noordin S, McEwen JA, Kragh JF Jr, Eisen A, Masri BA. Surgical tourniquets in orthopaedics. J Bone Joint Surg Am. 2009 Dec;91(12):2958-67. doi: 10.2106/JBJS.I.00634.
- Karaoglu S, Dogru K, Kabak S, Inan M, Halici M. Effects of epinephrine in local anesthetic mixtures on hemodynamics and view quality during knee arthroscopy. Knee Surg Sports Traumatol Arthrosc. 2002 Jul;10(4):226-8. doi: 10.1007/s00167-001-0257-8. Epub 2001 Nov 23.
- Zhongyu X, Zhen Y, Bingqing G, Xintian K, Meifeng G, Jianda X. Intra-articular administration of adrenaline plus an irrigation pump system for visibility during the arthroscopic reconstruction of multiple knee ligaments without a tourniquet. Front Surg. 2023 Mar 17;10:1045839. doi: 10.3389/fsurg.2023.1045839. eCollection 2023.
- Kirkley A, Rampersaud R, Griffin S, Amendola A, Litchfield R, Fowler P. Tourniquet versus no tourniquet use in routine knee arthroscopy: a prospective, double-blind, randomized clinical trial. Arthroscopy. 2000 Mar;16(2):121-6. doi: 10.1016/s0749-8063(00)90024-0.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 31/24
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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