Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
7 de marzo de 2016 actualizado por: Children's Hospital Medical Center, Cincinnati
The purpose of this study is to determine if an intravenous lidocaine infusion (compared to placebo) intraoperatively will decrease time to return of bowel function postoperatively, decrease postoperative pain, diminish postoperative opioid requirement, minimize inflammatory markers and shorten time to discharge after colorectal surgery.
Descripción general del estudio
Descripción detallada
Lidocaine is an amide local anesthetic that has analgesic and anti-inflammatory properties.
Lidocaine infusion is a very useful pain medication that is underutilized to treat surgical, chronic, and cancer pain in children.
The investigators propose to examine the perioperative use of lidocaine infusion in children undergoing colorectal surgery that involves an abdominal incision.
The investigators plan to measure the following outcomes: length of stay in hospital following abdominal surgery, postoperative pain scores, cumulative morphine consumption, incidences of opioid adverse-effects: respiratory depression, sedation, nausea, vomiting, time to passage of flatus, time to first bowel movement and end-tidal Sevoflurane in operating room throughout surgery.
The following laboratory values will be measured: serial lidocaine levels of pharmacokinetics and safety levels, Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA and genetic variants.
Tipo de estudio
Intervencionista
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical Center
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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
1 año a 15 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- male or female children 1-15 years of age
- ASA physical status 1-3
- scheduled for colorectal surgery with abdominal incision
- scheduled for complex urology surgical case
Exclusion Criteria:
- ASA physical status > 3
- postoperative intubation planned ahead of surgery
- history of chronic use of opioid
- history of hepatic,renal, or cardiac failure
- history of organ transplant
- BMI > 30
- history of cardiac arrhythmia
- history of long QT syndrome
- history of allergic reaction to lidocaine or similar agents
- history of seizure disorder
- patient without Peripherally Inserted Central Catheter or other central access with contraindication to inhalation induction
- family history or know patient susceptibility to malignant hyperthermia
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
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Lidocaine
The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes.
The bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr.
The infusion will be stopped after extubation prior to leaving the operating room or after 5 hours from the start of the infusion
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The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump.
This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr.
The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.
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Comparador de placebos: Saline
The saline will be administered over an infusion pump over 10 minutes and followed by a bolus.
The infusion will be stopped after extubation prior to leaving the operating room or after 5 hours from the start of the infusion.
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The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump.
This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr.
The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Length of stay in hospital following abdominal surgery
Periodo de tiempo: participants will be followed for the duration of hospital stay, an average of 1 week
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The primary outcome measure will be to monitor the length of stay in hospital following abdominal surgery.
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participants will be followed for the duration of hospital stay, an average of 1 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Postoperative pain scores
Periodo de tiempo: participants will be followed post-op, average 5 days
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Study staff will monitor patients pain every 15 minutes in the PACU and record documentation every 4 hours while on the floor.
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participants will be followed post-op, average 5 days
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Cumulative morphine consumption
Periodo de tiempo: participants will be followed post-op, average 5 days
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Staff will document how much morphine a patient uses post-operatively after abdominal surgery.
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participants will be followed post-op, average 5 days
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Incidences of opioid adverse-effects
Periodo de tiempo: participants will be followed post-op, average 5 days
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Study staff will monitor nursing notes for respiratory depression, sedation, nausea and vomiting
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participants will be followed post-op, average 5 days
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Time to passage of flatus and bowel movement
Periodo de tiempo: participants will be followed post-op, average 5 days
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Study staff will review nursing notes for time of passage of flatus and first bowel movement.
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participants will be followed post-op, average 5 days
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End-tidal Sevoflurane in operating room throughout surgery
Periodo de tiempo: participants will be measured until the end of the OR case, on average 6 hours
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participants will be measured until the end of the OR case, on average 6 hours
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Serial lidocaine levels for pharmacokinetics and safety levels
Periodo de tiempo: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
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2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs
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participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
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Pro- and anti-inflammatory cytokine measurements: IL-6, IL-8, IL-10, IL-1RA
Periodo de tiempo: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
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2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs
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participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
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Genetic variants
Periodo de tiempo: participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
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2 samples will be drawn at time of baseline IV placement Blood draw 0-3 minutes after bolus is complete Blood draw 9-15 minutes after the bolus is complete 2 blood samples will be drawn at the end of continuous infusion (either at end of surgery after extubation prior to leaving OR or after 5 hours from the start of the infusion) Blood draw 1 hour following the infusion Blood draw 2-3 hours following the end of the infusion 2 blood samples will be drawn 24 hours after surgery dependent of necessary labs
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participants will be measured until the end of the OR case, on average 6 hours and 24 hours post-operatively
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Smokey J Clay, MD, Children's Hospital Medical Center, Cincinnati
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
- Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.
- Harvey KP, Adair JD, Isho M, Robinson R. Can intravenous lidocaine decrease postsurgical ileus and shorten hospital stay in elective bowel surgery? A pilot study and literature review. Am J Surg. 2009 Aug;198(2):231-6. doi: 10.1016/j.amjsurg.2008.10.015. Epub 2009 Mar 12.
- Duedahl TH, Hansen EH. A qualitative systematic review of morphine treatment in children with postoperative pain. Paediatr Anaesth. 2007 Aug;17(8):756-74. doi: 10.1111/j.1460-9592.2007.02213.x.
- Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. doi: 10.1542/peds.2005-2920.
- Bulloch B, Tenenbein M. Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics. 2002 Sep;110(3):e33. doi: 10.1542/peds.110.3.e33.
- Groudine SB, Fisher HA, Kaufman RP Jr, Patel MK, Wilkins LJ, Mehta SA, Lumb PD. Intravenous lidocaine speeds the return of bowel function, decreases postoperative pain, and shortens hospital stay in patients undergoing radical retropubic prostatectomy. Anesth Analg. 1998 Feb;86(2):235-9. doi: 10.1097/00000539-199802000-00003.
- Ash-Bernal R, Wise R, Wright SM. Acquired methemoglobinemia: a retrospective series of 138 cases at 2 teaching hospitals. Medicine (Baltimore). 2004 Sep;83(5):265-273. doi: 10.1097/01.md.0000141096.00377.3f.
- McGrath PA, Seifert CE, Speechley KN, Booth JC, Stitt L, Gibson MC. A new analogue scale for assessing children's pain: an initial validation study. Pain. 1996 Mar;64(3):435-443. doi: 10.1016/0304-3959(95)00171-9.
- Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007.
- Candiotti KA, Yang Z, Morris R, Yang J, Crescimone NA, Sanchez GC, Bird V, Leveillee R, Rodriguez Y, Liu H, Zhang YD, Bethea JR, Gitlin MC. Polymorphism in the interleukin-1 receptor antagonist gene is associated with serum interleukin-1 receptor antagonist concentrations and postoperative opioid consumption. Anesthesiology. 2011 May;114(5):1162-8. doi: 10.1097/ALN.0b013e318216e9cb.
- Yardeni IZ, Beilin B, Mayburd E, Levinson Y, Bessler H. The effect of perioperative intravenous lidocaine on postoperative pain and immune function. Anesth Analg. 2009 Nov;109(5):1464-9. doi: 10.1213/ANE.0b013e3181bab1bd.
- Annabi EH, Barker SJ. Severe methemoglobinemia detected by pulse oximetry. Anesth Analg. 2009 Mar;108(3):898-9. doi: 10.1213/ane.0b013e318172af73.
- LUND PC, CWIK JC. PROPITOCAINE (CITANEST) AND METHEMOGLOBINEMIA. Anesthesiology. 1965 Jul-Aug;26:569-71. doi: 10.1097/00000542-196507000-00020. No abstract available.
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 enero de 2015
Finalización primaria (Anticipado)
1 de marzo de 2018
Finalización del estudio (Anticipado)
1 de abril de 2018
Fechas de registro del estudio
Enviado por primera vez
8 de abril de 2013
Primero enviado que cumplió con los criterios de control de calidad
17 de abril de 2013
Publicado por primera vez (Estimar)
22 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
8 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
7 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Complicaciones Postoperatorias
- Dolor
- Manifestaciones neurológicas
- Dolor Postoperatorio
- Efectos fisiológicos de las drogas
- Mecanismos moleculares de acción farmacológica
- Agentes antiarrítmicos
- Depresores del sistema nervioso central
- Agentes del sistema nervioso periférico
- Agentes del sistema sensorial
- Anestésicos
- Moduladores de transporte de membrana
- Anestésicos Locales
- Bloqueadores de canales de sodio activados por voltaje
- Bloqueadores de canales de sodio
- Lidocaína
Otros números de identificación del estudio
- CCHMC 2012-0674
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Lidocaine
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