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- Sperimentazione clinica NCT02862769
Intra-operative Lidocaine Infusion in Preventing CPSP Post VATs
The Role of Intra-operative Lidocaine Infusion in Preventing Chronic Post Surgical Pain After Video Assisted Thoracoscopic Surgery
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
It is not surprising that complications related to surgical procedures occur. Chronic Post Surgical Pain (CPSP) is considered one of the more common surgical complications, despite all the advances in understanding acute pain and the development of new modalities for pain management 1. Chronic Post Surgical Pain was defined by Macrae and Davies 7 as a persistent pain, which existed for a minimum of two months following a surgical procedure. The condition of pre-existence of pain, and causes for the pain other than surgery should be excluded. Thoracic surgeries including thoracotomy and video-assisted thoracoscopic surgery (VATS) are some of the highest risk procedures that often lead to CPSP. The prevalence of chronic pain after VATS is close to that after thoracotomy (25-47 %), half of them having neuropathic pain A, B. Because of the fact that chronic pain is a major physical and mental health care problem affecting the patient and the community in general, it has become essential for physicians to prevent the development of chronic pain 8.
While multimodal analgesia has largely replaced pain mono-therapy with opioids, they remain the most commonly used medications to treat post operative pain. Lidocaine is an amide local anesthetic which when used intravenously demonstrates significant analgesic, anti-hyperalgesic and anti-inflammatory properties . It also reduces the sensitivity and activity of spinal cord neurons, decreases N-methyl-D-aspartate (NMDA) receptors mediated post-synaptic depolarization. The analgesic effects of systemic lidocaine were first tested in chronic neuropathic pain when the results support the usage of these drugs. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect. Perioperative lidocaine administration was associated with a decreased incidence of CPSP when it is associated with neuropathic pain . It reduced CPSP in mastectomy by 40-50% after 3 and 6 months follow-up. To the best of our knowledge there is no study that has addressed the usage of lidocaine in VATS or thoracotomy.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Ontario
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London, Ontario, Canada, N6A 5W9
- Reclutamento
- London Health Sciences Centre
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Contatto:
- zameer pirani
- Numero di telefono: 5198514595
- Email: piranizameer@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- VATs for lobectomy
- Understanding of English (reading, writing and speaking)
- Written consent for being involved in this study
- Exclusion Criteria:
- Chronic pain including fibromyalgia
- Patients using opioids (more than 80 mg equivalent of oral morphine/day for >60 days)
- Major depression
- Received or going to receive chemotherapy or radiotherapy.
- Pregnant
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Lidocaine infusion
first group (lidocaine group) will include those who receive a intraoperative lidocaine infusion (Induction bolus dose of 1.5 mg/kg body weight followed by a continous lidocaine infusion
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. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1.
At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect.
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Comparatore placebo: Saline Infusion
The second group will include those who receive a intraoperative placebo i(Induction bolus dose of 1.5 mg/kg body weight of lidocaine followed by a continous saline infusion at the same rate as the lidocaine infusion.
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. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1.
At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect.
The second group will include those who receive a intraoperative placebo infusion(saline infusion) (Induction bolus dose of 1.5 mg/kg body weight followed by a continous saline infusion 1.5 mg/kg/hr.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Chronic Pain post VATs
Lasso di tempo: 3 months
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Using the Brief Pain Inventory Scale
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3 months
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Chronic Pain post VATs
Lasso di tempo: 6 months
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Using the Brief Pain Inventory Scale
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6 months
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Opioid requirement
Lasso di tempo: 48 hours
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Calculating Opioid dose(1hr, 6hr, 24 hrs and 48 hrs)
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48 hours
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Pain Score for Acute Post Operative Pain
Lasso di tempo: 48 hours post-op
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Using Numerical Pain Scale
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48 hours post-op
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Mean Pain Scores
Lasso di tempo: 3 and 6 months
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3 and 6 months
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Pain interference
Lasso di tempo: 3 and 6 months
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Using the Brief Pain Inventory
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3 and 6 months
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Qutaiba Tawfic Hamodi, Western University
Pubblicazioni e link utili
Pubblicazioni generali
- Bruce J, Quinlan J. Chronic Post Surgical Pain. Rev Pain. 2011 Sep;5(3):23-9. doi: 10.1177/204946371100500306.
- Steegers MA, Snik DM, Verhagen AF, van der Drift MA, Wilder-Smith OH. Only half of the chronic pain after thoracic surgery shows a neuropathic component. J Pain. 2008 Oct;9(10):955-61. doi: 10.1016/j.jpain.2008.05.009. Epub 2008 Jul 16.
- Peng Z, Li H, Zhang C, Qian X, Feng Z, Zhu S. A retrospective study of chronic post-surgical pain following thoracic surgery: prevalence, risk factors, incidence of neuropathic component, and impact on qualify of life. PLoS One. 2014 Feb 28;9(2):e90014. doi: 10.1371/journal.pone.0090014. eCollection 2014.
- Usichenko TI, Rottenbacher I, Kohlmann T, Julich A, Lange J, Mustea A, Engel G, Wendt M. Implementation of the quality management system improves postoperative pain treatment: a prospective pre-/post-interventional questionnaire study. Br J Anaesth. 2013 Jan;110(1):87-95. doi: 10.1093/bja/aes352. Epub 2012 Oct 9.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie del sistema nervoso
- Dolore
- Manifestazioni neurologiche
- Malattie neuromuscolari
- Malattie del sistema nervoso periferico
- Dolore cronico
- Nevralgia
- Dolore acuto
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti antiaritmici
- Depressori del sistema nervoso centrale
- Agenti del sistema nervoso periferico
- Agenti del sistema sensoriale
- Anestetici
- Modulatori di trasporto a membrana
- Anestetici, Locali
- Bloccanti dei canali del sodio voltaggio-dipendenti
- Bloccanti dei canali del sodio
- Lidocaina
Altri numeri di identificazione dello studio
- HSREB 107989
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Dolore cronico
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University of OklahomaThe Children's Hospital at OU Medical CenterCompletatoDolore addominale funzionale | Crisi falciforme | Pazienti seguiti dal Pain Team
Prove cliniche su Lidocaine
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University of PecsMedical University of PecsCompletato