- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07246642
Colocación de IPP & Bloqueo Intracavernoso (IPP)
Ensayo controlado aleatorizado de anestesia local intracorporal frente a solución salina antes de la colocación de prótesis de pene inflable
The inflatable penile prosthesis (IPP) is the gold standard for surgical management of erectile dysfunction (ED) and there is no consensus on the best postoperative pain management regimen. In the wake of the opioid epidemic, postoperative pain management is heavily scrutinized. The National Institute of Health estimated over 81,000 individuals died following overdose of any opioids in 2022 alone; of these, over 14,000 deaths were linked to prescription opioids. Thus, strategies to minimize postoperative pain should not only improve patient experience but also lessen the need to escalate to opioid usage.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
It would be ideal to create an effective and easily reproducible approach to pain prevention and pain management in men undergoing IPP placement. One highly appealing target would be intracavernosal administration, as there would be no ambiguity regarding delivery of agent at the time of surgery. Thus far, no prospective randomized controlled trials have explored the efficacy of intracavernosal administration of local anesthetic for pain management.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Sachin Vyas
- Número de teléfono: 336.713.4098
- Correo electrónico: Sachin.Vyas@Advocatehealth.org
Copia de seguridad de contactos de estudio
- Nombre: Kimberly Waggener, MD
- Número de teléfono: 336.713.4098
- Correo electrónico: kimberly.waggener@advocatehealth.org
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences
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Contacto:
- Sachin Vyas
- Número de teléfono: 336-713-4098
- Correo electrónico: Sachin.Vyas@Advocatehealth.org
-
Contacto:
- Kimberly Waggener, MD
- Número de teléfono: 336.713.4098
- Correo electrónico: kimberly.waggener@advocatehealth.org
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Any patient undergoing primary three-piece inflatable penile prosthesis (IPP) placement at Lexington Medical Center
Exclusion Criteria:
- Patients undergoing revision and/or secondary IPP placement
- Patients taking prescribed narcotic medications at the time of IPP surgery
- Patients undergoing concomitant Peyronie's Disease surgery (modeling, plication, grafting) at the time of IPP surgery
- Patients with liver and/or renal disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control Saline Arm
10cc of normal saline will be injected into each corporal body (left and right for a total of 20cc) |
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Experimental: Exparel/bupivacaine mixture Arm
10cc Exparel/bupivacaine mixture will be injected into each corporal body (left and right for a total of 20cc) |
10cc of Exparel (133 mg, 1.3%) with 10cc of 0.5% standard bupivacaine (50 mg )for total volume of 20cc into the corpora immediately prior to placement of corporotomy stay sutures.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analogue Scale (VAS) Scores
Periodo de tiempo: Hour 1
|
VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain. |
Hour 1
|
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Visual Analogue Scale (VAS) Scores
Periodo de tiempo: Hour 4
|
VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain. |
Hour 4
|
|
Visual Analogue Scale (VAS) Scores
Periodo de tiempo: Hour 24
|
VAS scores range from 0 to 100, with 0 representing no pain or the least desirable state and 100 representing the worst possible pain or the most desirable state. The "score" is the distance in millimeters from the "no pain" end of the 100mm line to the point where the person marks their pain level. Lower scores (0-4mm) indicate no pain, while higher scores (75-100mm) indicate severe pain. |
Hour 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cumulative Morphine milligram equivalents (MME)
Periodo de tiempo: Day 2
|
Cumulative morphine milligram equivalent (MME) is a metric used by healthcare providers to standardize the total potency of all opioid medications a patient is taking. By converting each opioid into a standard value based on morphine, providers can assess a patient's overall risk for overdose and other complications. Higher cumulative MME levels are associated with a greater risk of overdose. For example, doses of 50 MME or more per day increase overdose risk and warrant closer monitoring, while doses of 90 MME or more are considered very high. |
Day 2
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Number of calls, messages, or visits to clinic
Periodo de tiempo: Day 30
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Physician access line calls, messages to clinic, visits to clinic for postoperative pain within 30 days after surgery |
Day 30
|
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Number of Complications
Periodo de tiempo: Day 30
|
Complications from intracavernosal injections |
Day 30
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Number of Other Complications
Periodo de tiempo: Day 30
|
Other complications after IPP surgery using the Clavien-Dindo grading scale - The Clavien-Dindo scale is a grading system that categorizes surgical complications based on the treatment required to manage them, providing a uniform and objective way to assess and report post-operative events. It consists of five grades, with Grade I being minor deviations not requiring intervention and Grade V indicating patient death |
Day 30
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Serum bupivacaine levels
Periodo de tiempo: Hours 1 and 24
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Serum bupivacaine levels at 1 hour and 1 day after surgery - Serum bupivacaine levels are a measurement of the drug in the blood, and the "normal" or safe level varies significantly by the patient's condition, the administration site, and the dose - A 1-mL serum or plasma sample is typically collected in a red-top or green-top tube |
Hours 1 and 24
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Amount of tramadol usage
Periodo de tiempo: Hour 24
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Use the lowest dose possible for the shortest time needed. Take your prescribed dose as indicated by your healthcare provider. The maximum dosage is 1 or 2 tablets every 4 to 6 hours, as needed for pain relief. |
Hour 24
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ryan Terlecki, MD, Wake Forest University Health Sciences
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- Enfermedades urogenitales
- Enfermedades Genitales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Enfermedades Genitales Masculinas
- Enfermedades urogenitales masculinas
- Manifestaciones neuroconductuales
- Disfunción Sexual Fisiológica
- Disfunciones Sexuales Psicológicas
- Trastornos de la percepción
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Disfuncion erectil
- Agnosia
Otros números de identificación del estudio
- IRB00129597
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
All of the Individual participant data collected during the trial, after deidentification
Marco de tiempo para compartir IPD
Immediately following publication - no end date
Criterios de acceso compartido de IPD
anyone who wishes to access the data
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
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.
producto fabricado y exportado desde los EE. UU.
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