Effect of Transversus Abdominis Plane Block on Anti-inflammatory Response
16. januar 2020 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Forventet)
70
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Malatya, Tyrkia, 044100
- Rekruttering
- Inonu University
-
Ta kontakt med:
- Mehmet A Erdogan, MD
- Telefonnummer: +904223410660
- E-post: drmalierdogan@gmail.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: TAP Block Group
this is study group.
|
TAP block which is a peripheral nerve block preferred to postoperative pain management.
|
|
Ingen inngripen: Control Group
This patients are control group.
TAP block will be not perform
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
cytokine level (interleukine-1, interleukine-6, tumor necrosis factor)
Tidsramme: Change from baseline cytokines levels at 24 hours postoperatively
|
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.
|
Change from baseline cytokines levels at 24 hours postoperatively
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
correlation of plasma bupivacaine level and cytokine level
Tidsramme: Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively
|
The relationship between plasma bupivacaine level and cytokine level in patients undergoing TAP block
|
Change from baseline correlation of plasma bupivacaine level and cytokines levels at 24 hours postoperatively
|
|
The plasma bupivacaine concentrations
Tidsramme: Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively
|
The plasma bupivacaine concentrations in patients undergoing TAP block
|
Change from baseline plasma bupivacaine concentrations at 24 hours postoperatively
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Ulku Ozgul, MD, Inonu University, Scholl of Madicine, Malatya Turkey
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. desember 2019
Primær fullføring (Forventet)
15. juni 2020
Studiet fullført (Forventet)
1. juli 2020
Datoer for studieregistrering
Først innsendt
17. desember 2019
Først innsendt som oppfylte QC-kriteriene
16. januar 2020
Først lagt ut (Faktiske)
18. januar 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. januar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. januar 2020
Sist bekreftet
1. januar 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- MAE7
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .