Intravenous Lidocaine Infusion in the Management of Post-operative Pain in Colorectal Patients
7 mars 2016 mis à jour par: 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.
Aperçu de l'étude
Description détaillée
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.
Type d'étude
Interventionnel
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- Cincinnati Children's Hospital Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
1 an à 15 ans (Enfant)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 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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Comparateur placebo: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Length of stay in hospital following abdominal surgery
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Postoperative pain scores
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Les enquêteurs
- Chercheur principal: Smokey J Clay, MD, Children's Hospital Medical Center, Cincinnati
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2015
Achèvement primaire (Anticipé)
1 mars 2018
Achèvement de l'étude (Anticipé)
1 avril 2018
Dates d'inscription aux études
Première soumission
8 avril 2013
Première soumission répondant aux critères de contrôle qualité
17 avril 2013
Première publication (Estimation)
22 avril 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
8 mars 2016
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 mars 2016
Dernière vérification
1 mars 2016
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Complications postopératoires
- La douleur
- Manifestations neurologiques
- Douleur, Postopératoire
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents anti-arythmie
- Dépresseurs du système nerveux central
- Agents du système nerveux périphérique
- Agents du système sensoriel
- Anesthésiques
- Modulateurs de transport membranaire
- Anesthésiques locaux
- Bloqueurs de canaux sodiques voltage-dépendants
- Bloqueurs des canaux sodiques
- Lidocaïne
Autres numéros d'identification d'étude
- CCHMC 2012-0674
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