Nociceptin Concentration in Synovial Fluid and Plasma
17 de marzo de 2016 actualizado por: Julia Caldwell, Milton S. Hershey Medical Center
Nociceptin Concentration in Synovial Fluid and Plasma in Patients Undergoing Primary Total Knee Arthroplasty: A Prospective Pilot Study
Nociceptin/Orphanin is a novel opioid peptide system associated with inflammatory response.
Currently is it uncertain as to the presence of absence of nociceptin in synovial fluid of patients.
Nociceptin levels will be measured pre-operatively and post-operatively in plasma levels of patients receiving primary total knee arthroplasty.
Nociceptin levels will also be measured in synovial fluid levels prior to surgical manipulation.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
This is a prospective observational study where nociceptin levels will be drawn from the patient's serum as well as from the patient's synovial fluid. The blood draws will be completed by the anesthesia team and the synovial fluid and tissue will be obtained by the orthopedic team. The initial blood draw will be in the preoperative area and the second blood draw will be five minutes after the release of the tourniquet. The synovial fluid will be drawn by the surgeon with the first incision. There will be no randomization nor control group.
Endpoints:
- The level or absence of nociceptin in synovial fluid in patients receiving total knee primary arthroplasty will be measured via ELISA in picograms per volume.
- The level or absence of nociceptin in plasma in patients receiving total knee primary arthroplasty both in the preoperative period (less than 1 hour prior to surgery and 5 minutes after the tourniquet is removed) via ELISA in picograms per volume.
- Determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.
Secondary Study Endpoints:
- Determine the effect if present of history of chronic pain and opioid use on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty.
- Determine the effect if present of demographic factors on the levels of nociception present in patients' synovial fluid and plasma receiving primary total knee arthroplasty
Tipo de estudio
De observación
Inscripción (Actual)
22
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Sequential patients receiving primary unilateral knee arthroplasty by the same surgeon
Descripción
Inclusion Criteria:
- receiving a primary knee joint arthroplasty by Dr. Davis ages 18-80 years hemodynamically stable no joint or other types of infection informed consent received and signed no prior joint arthroplasty at the current surgical site no other surgical intervention planned
Exclusion Criteria:
- prior knee arthroplasty at site outside of desired age range pregnant current infection in joint or other location no desire to participate
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Primary Knee Arthroplasty Patients
Patients who consented, met inclusion and exclusion criteria, had plasma and synovial fluid samples drawn as described in the included protocol.
No interventions were completed.
No changes to standard of care treatment completed.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nociceptin in Synovial Fluid
Periodo de tiempo: The surgeon will make a small incision after the patient has been anesthetized and prepped and draped. He will then withdraw the synovial fluid and then will begin the surgery after the fluid is removed.
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The level or absence of nociceptin in synovial fluid will be measured using ELISA and represented in picograms per volume.
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The surgeon will make a small incision after the patient has been anesthetized and prepped and draped. He will then withdraw the synovial fluid and then will begin the surgery after the fluid is removed.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nociceptin in Plasma
Periodo de tiempo: Blood will be drawn in the preoperative period (approximately up to 1 hour prior to surgery).
|
Determine the presence of absence of nociceptin in plasma in patients receiving total knee primary arthroplasty and determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.
Nociceptin will be measured using ELISA and represented in terms of picograms per volume.
|
Blood will be drawn in the preoperative period (approximately up to 1 hour prior to surgery).
|
|
Nociceptin in Plasma
Periodo de tiempo: Blood will be drawn 5 minutes after the release of the tourniquet.
|
Determine the presence of absence of nociceptin in plasma in patients receiving total knee primary arthroplasty and determine the changes if any of nociception plasma levels during the perioperative course of patients receiving total primary knee arthroplasty.
Nociceptin will be measured using ELISA and represented in terms of picograms per volume.
|
Blood will be drawn 5 minutes after the release of the tourniquet.
|
|
Patient Demographics
Periodo de tiempo: Will be determined in the preoperative period up to one hour prior to surgery.
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Age
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Will be determined in the preoperative period up to one hour prior to surgery.
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Patient Demographics
Periodo de tiempo: Will be determined in the preoperative period up to one hour prior to surgery.
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Gender
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Will be determined in the preoperative period up to one hour prior to surgery.
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Patient Demographics
Periodo de tiempo: Will be determined in the preoperative period up to one hour prior to surgery
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BMI
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Will be determined in the preoperative period up to one hour prior to surgery
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Patient Pain Scores
Periodo de tiempo: One set of preoperative scores will be obtained up to one hour prior to surgery.
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pre-operative pain scores will be determined using the 0-10 verbal analog scale.
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One set of preoperative scores will be obtained up to one hour prior to surgery.
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Patient Pain Scores
Periodo de tiempo: One set of post operative pain scores will be obtained up to one hour post emergence from anesthesia.
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post-operative pain scores will be determined using the 0-10 verbal analog scale.
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One set of post operative pain scores will be obtained up to one hour post emergence from anesthesia.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Chiou LC, Liao YY, Fan PC, Kuo PH, Wang CH, Riemer C, Prinssen EP. Nociceptin/orphanin FQ peptide receptors: pharmacology and clinical implications. Curr Drug Targets. 2007 Jan;8(1):117-35. doi: 10.2174/138945007779315605.
- Lin AP, Ko MC. The therapeutic potential of nociceptin/orphanin FQ receptor agonists as analgesics without abuse liability. ACS Chem Neurosci. 2013 Feb 20;4(2):214-24. doi: 10.1021/cn300124f. Epub 2012 Nov 6.
- Kumar N, Smart D, Mason S, McKnight AT, Rowbotham DJ, Lambert DG. Neither nociceptin nor its receptor are present in human synovial fluid or tissue. Br J Anaesth. 1999 Sep;83(3):470-1. doi: 10.1093/bja/83.3.470.
- Verbeek TA, Jarbadan NR, Davis C, Caldwell J. Nociceptin is present in synovial fluid of patients undergoing total knee arthroplasty. J Orthop Surg Res. 2020 Jul 16;15(1):266. doi: 10.1186/s13018-020-01789-1.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2014
Finalización primaria (Actual)
1 de septiembre de 2015
Finalización del estudio (Actual)
1 de septiembre de 2015
Fechas de registro del estudio
Enviado por primera vez
5 de julio de 2015
Primero enviado que cumplió con los criterios de control de calidad
18 de agosto de 2015
Publicado por primera vez (Estimar)
19 de agosto de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
18 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
17 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 42679
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