- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Fase 4
Kontakter og lokationer
Studiesteder
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Ontario
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- London Health Sciences Centre
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Kontakt:
- zameer pirani
- Telefonnummer: 5198514595
- E-mail: piranizameer@gmail.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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
|
. 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.
|
Placebo komparator: 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.
|
. 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Chronic Pain post VATs
Tidsramme: 3 months
|
Using the Brief Pain Inventory Scale
|
3 months
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Chronic Pain post VATs
Tidsramme: 6 months
|
Using the Brief Pain Inventory Scale
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Opioid requirement
Tidsramme: 48 hours
|
Calculating Opioid dose(1hr, 6hr, 24 hrs and 48 hrs)
|
48 hours
|
Pain Score for Acute Post Operative Pain
Tidsramme: 48 hours post-op
|
Using Numerical Pain Scale
|
48 hours post-op
|
Mean Pain Scores
Tidsramme: 3 and 6 months
|
3 and 6 months
|
|
Pain interference
Tidsramme: 3 and 6 months
|
Using the Brief Pain Inventory
|
3 and 6 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Qutaiba Tawfic Hamodi, Western University
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i nervesystemet
- Smerte
- Neurologiske manifestationer
- Neuromuskulære sygdomme
- Sygdomme i det perifere nervesystem
- Kronisk smerte
- Neuralgi
- Akut smerte
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Membrantransportmodulatorer
- Bedøvelsesmidler, lokale
- Spændingsstyret natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
Andre undersøgelses-id-numre
- HSREB 107989
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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