Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response
16. januar 2020 opdateret af: Mehmet Ali Erdoğan, Inonu University
Effect of Transversus Abdominis Plane Block With Bupivacaine on Anti-inflammatory Response in Living Liver Donors
The liver transplantation is the only treatment for end-stage liver failure.
Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation.
A peripheral nerve block, transversus abdominous plane block (TAP block); When combined with general anesthesia in live liver donors, it has been shown to significantly reduce perioperative and postoperative opioid consumption, provide shorter recovery time and shorten hospital stay.
It has been shown that regional block techniques using local anesthetics and analgesic adjuvants modulate both local and systemic inflammatory reactions caused by surgical injury.
Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery.
In literature, the effect of TAP block on anti-inflammatory cytokines in live liver donors was not shown.
The aim of this study is to investigate the effect of bupivacaine TAP block on antiflammatory response in living liver donors.
Studieoversigt
Status
Ukendt
Intervention / Behandling
Detaljeret beskrivelse
The liver transplantation is the only treatment for end-stage liver failure.
Lack of sufficient organs from the cadaver to meet the organ needs has increased the interest in a live organ donor transplantation.
A peripheral nerve block, transversus abdominous plane block (TAP block); When combined with general anesthesia in live liver donors, it has been shown to significantly reduce perioperative and postoperative opioid consumption, provide shorter recovery time and shorten hospital stay.Immunological, metabolic and endocrine reactions occur due to tissue damage, pain and anesthesia caused by surgery.
It has been shown that regional block techniques using local anesthetics and analgesic adjuvants modulate both local and systemic inflammatory reactions caused by surgical injury.
Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery.
Cytokines are indispensable for wound healing and restoration of homeostasis, but usually the overactivity of either proinflammatory or anti-inflammatory cytokines damages the host.
With Preemptive epidural analgesia, peripheral nerve block and thoracic epidural analgesia; postoperative pain and proinflammatory cytokines have been reduced.
In literature, the effect of TAP block on anti-inflammatory cytokines in live liver donors was not shown.
The aim of this study is to investigate the effect of bupivakine TAP block on antiinflammatory response in live liver donors.This prospective clinical study will performs in 72 liver transplant donors aged 18-65 years, ASA I-II, schedule for right hepatectomy surgery.
Peripheral vascular access will open and blood samples will take for preoperative cytokine and bupivacaine measurements.The primary aim of this study was to investigate the effect of TAP block on the inflammatory response by cytokine level.
The secondary aim of this study is to determine the plasma bupivacaine concentrations in patients undergoing TAP block and to investigate the relationship between plasma bupivacaine level and cytokine levels.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
70
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Malatya, Kalkun, 044100
- Rekruttering
- Inonu University
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Kontakt:
- Mehmet A Erdogan, MD
- Telefonnummer: +904223410660
- E-mail: drmalierdogan@gmail.com
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- liver transplant donors schedule for right hepatectomy surgery.
- aged 18-65 years,
Exclusion Criteria:
- systemic disease (such as diabetes and hypertension),
- used opioid or NSAID in the last week,
- coagulation pathology,
- a history of allergy to drugs used in the study
- refusal to participate in the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: TAP Block Group
this is study group.
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TAP block which is a peripheral nerve block preferred to postoperative pain management.
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Ingen indgriben: Control Group
This patients are control group.
TAP block will be not perform
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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cytokine level (interleukine-1, interleukine-6, tumor necrosis factor)
Tidsramme: Change from baseline cytokines levels at 24 hours postoperatively
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Immunological, metabolic and endocrine reactions occur due to tissue damage, pain and anesthesia caused by surgery.
Cytokines are important mediators of local and systemic inflammatory response including hyperalgesia after surgery.
Cytokines are indispensable for wound healing and restoration of homeostasis, but usually the overactivity of either proinflammatory or anti-inflammatory cytokines damages the host.
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Change from baseline cytokines levels at 24 hours postoperatively
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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correlation of plasma bupivacaine level and cytokine level
Tidsramme: Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively
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The relationship between plasma bupivacaine level and cytokine level in patients undergoing TAP block
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Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively
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The plasma bupivacaine concentrations
Tidsramme: Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively
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The plasma bupivacaine concentrations in patients undergoing TAP block
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Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Ulku Ozgul, MD, Inonu University, Scholl of Madicine, Malatya Turkey
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Bagry H, de la Cuadra Fontaine JC, Asenjo JF, Bracco D, Carli F. Effect of a continuous peripheral nerve block on the inflammatory response in knee arthroplasty. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):17-23. doi: 10.1016/j.rapm.2007.06.398.
- Kitlik A, Erdogan MA, Ozgul U, Aydogan MS, Ucar M, Toprak HI, Colak C, Durmus M. Ultrasound-guided transversus abdominis plane block for postoperative analgesia in living liver donors: A prospective, randomized, double-blinded clinical trial. J Clin Anesth. 2017 Feb;37:103-107. doi: 10.1016/j.jclinane.2016.12.018. Epub 2017 Jan 7.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
2. december 2019
Primær færdiggørelse (Forventet)
15. juni 2020
Studieafslutning (Forventet)
1. juli 2020
Datoer for studieregistrering
Først indsendt
17. december 2019
Først indsendt, der opfyldte QC-kriterier
16. januar 2020
Først opslået (Faktiske)
18. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
18. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. januar 2020
Sidst verificeret
1. januar 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- MAE7
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Ingen
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Ingen
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