- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01534416
Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery
Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain.
Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5-10).
For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery.
Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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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:
- Female
- Age 18 or older
- Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy
- Surgery being performed for benign disease
Exclusion Criteria:
- Male
- Women under 18 years old
- Pregnancy
- Suspected or known malignant disease
- Immunocompromised
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Bupivacaine
Subjects receive paracervical block with bupivacaine-epinephrine
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Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
Otros nombres:
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Comparador de placebos: Saline
Subjects receive paracervical injection of normal saline
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Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of Participants With Hospital Admission for Postoperative Pain Control
Periodo de tiempo: Four hours after conclusion of surgery
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Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management
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Four hours after conclusion of surgery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Pain Score
Periodo de tiempo: 1and 2 hour postoperatively
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Postoperative pain levels assessed using the visual analogue pain scale.
This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain.
In the PACU pain assessed using this scale by the nursing staff.
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1and 2 hour postoperatively
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Postoperative Pain Score
Periodo de tiempo: 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative
|
Postoperative pain levels assessed using the visual analogue pain scale.
This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain.
In the PACU pain assessed using this scale by the nursing staff.
On postoperative days 1 and 2 the subjects self-reported their pain level.
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1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative
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Postoperative Day Pain Medication Use
Periodo de tiempo: Postoperative days 0-10
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Numbers of Patients Using Pain Medication on Postoperative Days 1-10.
The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.
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Postoperative days 0-10
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Charles Ascher-Walsh, MD, Icahn School of Medicine at Mount Sinai
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
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
- GCO 11-0021
- HS# 11-00013
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