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Evaluating the Relationship of Morphine Consumption and Pain-related Molecules in Hepatic Surgical Patients

27. März 2018 aktualisiert von: Yen Chin Liu, National Cheng-Kung University Hospital

According to above basic findings, it is important to confirm those results in clinic. In this branch, the investigators will use patient control analgesic (PCA) device to investigate the consumption of morphine for patients undergoing hepatic surgery. Preoperative and postoperative (before and after surgery) blood will be sampling (15cc/time) and y liver tissue (10mm3) will be harvested to measure the expression of above molecules (TM, IL-20, HD). Pain questionnaire will also be applied to evaluate their pain control quality. Certainly, the morphine consumption and results from pain questionnaire will be correlated with the molecule amount to figure out possible relationship between morphine consumption and those molecules.

Patients undergoing abdominal surgery and using morphine pain control analgesia (PCA) device will be involved. Pre- and Post- operative (after anesthesia and at the end of surgery) blood sampling (total 30 ml) plus normal liver tissue (10mm3) e will be harvested. Above protein(TM, IL-20, HD) amount change will be measured (ELISA for TM, IL-20 (serum) or flowcytometry (white cells) for TM, HD, IL-20 expression, stain or blotting for skin tissue). Patients will be included in this branch to check the correlation between morphine consumption and protein expression. Pain questionnaire (BPI, McGill) will be applied for pain evaluation. 2-D gel analysis will also be applied to screen further possible molecules.

Specific aims

  1. To investigate the correlation of morphine consumption and the serum amount of IL-20, TM or HD
  2. To investigate the relationship between IL-20, TM, HD amount in liver tissue and morphine consumption

Studienübersicht

Status

Abgeschlossen

Detaillierte Beschreibung

As the investigators all know, pain, as an ancient enemy to human kind, was one of the most mystical phenomena within our body. For centuries, people search the magic wand to solve this issue and reach the heaven destination. However, like our original sin commit by Adam and Eve, the shadow of pain always surround and even rebel our body and spirit. Even more, pain traps our soul and body not only for the acute stage induced by noxious stimulation but also change our mind and body whenever chronic period start even the stimulation disappears. Pain so far has become one of the greatest health issues for modern people. It affects millions of people and the treatment options are quite limited and not effective everyone. Drugs for pain relief are quite few kinds and associated with lots of side effect. On the other way, why and how people develop chronic pain, especially when there is no further painful stimulation, remain to be investigated. The integrated project, combining with our preliminary study and novel findings in our university (TM, IL-20, HD), will not only set a platform for pain drug discovery and their possible pathway in pain mechanism but also provide important clinical data for patients with severe pain under major surgery. Four sub-projects were included in this integrated project: 1. IL-20 is important in analgesia and pain mechanism. 2. the potential of thrombomodulin as an analgesic. 3. Huntington mice produce less pain behavior. 4. The relationship of morphine consumption and TM, IL-20 and HD protein for post-operative patients.

1.Interleukin-20 (IL-20) is a proinflammatory cytokine belonging to the IL-10 family. IL-20 is produced by activated keratinocytes and monocytes and transmits an intracellular signal through two distinct cell-surface receptor complexes on keratinocytes and other epithelial cells. IL-20 regulates proliferation and differentiation of keratinocytes during inflammation, particularly inflammation associated with the skin. It is also involved in the pathogenesis of osteoporosis and is a new target to treat this disease. However, little data demonstrated its role on pain. Meanwhile, IL-10 was involved many pain models and suppresses IL-10 expression also reduce pain in animal models. In this sub-project, Our preliminary data demonstrated increase of IL-20 after morphine administration. Therefore, the investigators will explore the role of IL-20 in pain management.

2.)Thrombomodulin(TM) is a transmembranous glycoprotein, thrombin mediating formation of active protein C (APC) which involving proinflammatory and procoagulant process. Thrombomodulin- thrombin complex activate protein C and inhibits coagulation cascade. Lectin-like domain (D1) of TM prevents neutrophil and monocyte adhesion with inhibiting inflammation process. In addition, TM bind with HMGB1 (high-mobility group box 1) and prevent leukocyte activation demonstrated in previous study. HMGB1 appears to have a role in neuropathic pain involving dorsal root ganglion and peripheral nerve injury in recent investigations and develop many therapies aim to HMGB1 including antibody in recent days. HMGB1 interact with RAGE and related to induce hyperalgesia in a rodent model of neuropathic pain and pain hypersensitivity after peripheral nerve injury. In this branch study, the investigators will use various pain models to evaluate the expression of TM in tissues.

3.Huntington disease(HD) is neurodegenerative genetic disorder that affects muscle coordination. It caused by autosomal dominant mutation in Huntingtin gene and accumulates Huntington protein. This protein plays an important role in nerve cells. It upregulates Brain Derived Neurotrophic Factor (BDNF) and essential for development. It is associated with vesicles and microtubules and involved in vesicle trafficking. It also interact with over 100 other protein. However, less investigation focuses this protein on pain sensory level. Under the cooperation of Dr. Yang, the investigators will investigate the over-expression Huntington protein mice that will induce Huntington disease. The investigators will work on this issue and deepen our finding and produce a new view for this old disease.

4.According to above basic findings, it is important to confirm those results in clinic. In this branch, the investigators will use the patient control analgesic (PCA) device to investigate the consumption of morphine for patients undergoing hepatic surgery. Preoperative and postoperative blood will be sampling and tinny liver tissue (10mm3) will be harvested to correlate their morphine consumption and pain questionnaire will be evaluated for their pain control quality. Certainly, the morphine consumption will be correlated with the molecule amount to figure out possible relationship between morphine consumption and those molecules.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

15

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Shengli Rd
      • Tainan City, Shengli Rd, Taiwan, 701
        • National Cheng Kung University Hospital

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Patients undergoing liver surgery and using morphine pain control analgesia (PCA) device will be involved.

Beschreibung

Inclusion Criteria:

  1. Patients with resectable liver tumor and are over 18 years of age.
  2. Patients who present the will for his/her liver resection.
  3. Patients who are competent to understand the study and provide written informed consent and participate in outcome measurements.

Exclusion Criteria:

  • Patients have previous liver surgery. Patients are over 65 years of age. Patients are unable to read or write the pain questionaire, any condition that could interfere with the interpretation of outcome assessments, pregnant or lactating women or allergy to morphine.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Patients undergoing abdominal surgery
Patients undergoing abdominal surgery and using morphine pain control analgesia (PCA) device will be involved. Pre- and Post- operative (after anesthesia and at the end of surgery) blood sampling (total 30 ml) plus normal liver tissue (10mm3) e will be harvested. Above protein(TM, IL-20, HD) amount change will be measured (ELISA for TM, IL-20 (serum) or flowcytometry (white cells) for TM, HD, IL-20 expression, stain or blotting for skin tissue). Patients will be included in this branch to check the correlation between morphine consumption and protein expression. Pain questionnaire (BPI, McGill) will be applied for pain evaluation. 2-D gel analysis will also be applied to screen further possible molecules.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
consumption of morphine for patients undergoing hepatic surgery
Zeitfenster: 20 months
Preoperative and postoperative blood will be sampling and tinny liver tissue (10mm3) will be harvested to correlate their morphine consumption will be evaluated for their pain control quality.
20 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
various pain models of TM in tissues
Zeitfenster: 20 months
The investigators will use various pain models to evaluate the expression of TM in tissues. Pre- and Post- operative (after anesthesia and at the end of surgery) blood sampling (total 30 ml) plus normal liver tissue (10mm3) e will be harvested. Above protein(TM, IL-20, HD) amount change will be measured (ELISA for TM, IL-20 (serum) or flowcytometry (white cells) for TM, HD, IL-20 expression, stain or blotting for skin tissue).
20 months
HD over-expressed mice and pain behavior
Zeitfenster: 20 months
The investigators will work on HD over-expressed mice and pain behavior with morphine.
20 months
Change of IL-20 after morphine administration
Zeitfenster: 20 months
Interleukin-20 (IL-20) is a proinflammatory cytokine belonging to the IL-10 family. IL-20 is produced by activated keratinocytes and monocytes and transmits an intracellular signal through two distinct cell-surface receptor complexes on keratinocytes and other epithelial cells. IL-20 regulates proliferation and differentiation of keratinocytes during inflammation, particularly inflammation associated with the skin. It is also involved in the pathogenesis of osteoporosis and is a new target to treat this disease.
20 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

  • Studienstuhl: Yen-Chin Liu, Doctor, Department of Anesthesiology, National Cheng-Kung University Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2012

Primärer Abschluss (Tatsächlich)

1. Dezember 2012

Studienabschluss (Tatsächlich)

1. Dezember 2012

Studienanmeldedaten

Zuerst eingereicht

26. Juli 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. August 2013

Zuerst gepostet (Schätzen)

8. August 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. März 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. März 2018

Zuletzt verifiziert

1. März 2018

Mehr Informationen

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