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Antinociceptive Modalities on Ischemia Reperfusion Injury

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ClinicalTrials.gov Identifier: NCT01932918
Recruitment Status : Completed
First Posted : August 30, 2013
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Postoperative pain caused by surgery-associated tissue injury is a major concern for all the clinical practitioners. Because it affects multiple systems and induces physiological, immunological and psychological changes. Previous literature showed surgical injury induces a systemic inflammatory metabolic-endocrine response that is proportional to the severity of the surgical stress. In surgeries such as liver transplantation, the patients suffer not only from postoperative pain but also an additional oxidative stress caused by ischemia reperfusion. Previous report have proved that an adequate postoperative pain control improves the recovery and reduces the inflammatory cascade by suppression of physiological and psychological stresses. However, the effect of postoperative pain management on ischemia reperfusion injury is unclear so far. In this three year study, we plan to continue our previous study to test the following two hypothesis: (1) postoperative pain exacerbate remote organ injury caused by ischemia reperfusion, (2) the interaction of different antinociceptive modalities on ischemia reperfusion injury.

Condition or disease Intervention/treatment
End Stage Liver Disease Lung Cancer Drug: Patient controlled analgesia

Detailed Description:

Our team focused on the study of reperfusion injury in liver transplantation, lung resection and open heart surgeries which need cardiopulmonary bypass. Previous clinical observation showed the increase of lung water in liver transplant recipients. Some patients may even develop pulmonary edema which not only lengthen intensive care unit stay and hospital stay, but also increase morbidity and mortality. In the hepatic ischemia reperfusion animal model, we proved that the release of large amount of reactive oxygen species play an important part in remote lung injury. If propofol, which possesses free radical scavenger property, is given adequately, the production of reactive oxygen species will decrease thus reducing the extent of remote lung injury. In another clinical study, we found that resuming two lung ventilation from one lung ventilation induces a massive superoxide production, which also could be reduced when using propofol for the maintenance of anesthesia.

Postoperative pain caused by surgery-associated tissue injury is a major concern for all the clinical practitioners. Because it affects multiple systems and induces physiological, immunological and psychological changes. Previous literature showed surgical injury induces a systemic inflammatory metabolic-endocrine response that is proportional to the severity of the surgical stress. In surgeries such as liver transplantation, the patients suffer not only from postoperative pain but also an additional oxidative stress caused by ischemia reperfusion. Previous report have proved that an adequate postoperative pain control improves the recovery and reduces the inflammatory cascade by suppression of physiological and psychological stresses. However, the effect of postoperative pain management on ischemia reperfusion injury is unclear so far. In this three year study, we plan to continue our previous study to test the following two hypothesis: (1) postoperative pain exacerbate remote organ injury caused by ischemia reperfusion, (2) the interaction of different antinociceptive modalities on ischemia reperfusion injury.

In the first part, we plan to use the animal model that we have already established to test if analgesics reduce inflammatory responses and remote lung injury caused by hepatic ischemia and to study if different antinociceptive modalities result in different consequences. In the second part, we will recruit patients receiving liver transplantation, lung resection and open heart surgeries needing cardiopulmonary bypass to study the interaction of nociception and various antinociceptive modalities on ischemia reperfusion injury.

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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Interaction of Nociceptive Stimulation and Various Antinociceptive Modalities on Ischemia Reperfusion Injury
Study Start Date : January 2011
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Group/Cohort Intervention/treatment
PCA with morphine in liver transplant
Intravenous patient controlled analgesia with morphine was used for postoperative pain control in liver transplant recipients.
Drug: Patient controlled analgesia
  1. PCA with morphine in liver transplant:

    Intravenous patient controlled analgesia with morphine was used for postoperative pain control in liver transplant recipients.

  2. PCA with morphine and ketorolac:

    Patient controlled analgesia with morphine and ketorolac was used for postoperative pain control in liver transplant and thoracic surgery patients.

  3. Intravenous PCA in thoracic surgery Intravenous patient controlled analgesia was used for postoperative pain control in thoracic surgery patients.
  4. PCEA in thoracic surgery Patient controlled epidural analgesia was used for postoperative pain control in thoracic surgery patients.
Other Names:
  • morphine
  • ketorolac
  • marcaine

PCA with ketorolac in liver transplant
Patient controlled analgesia with morphine and ketorolac was used for postoperative pain control in liver transplant and thoracic surgery patients.
Drug: Patient controlled analgesia
  1. PCA with morphine in liver transplant:

    Intravenous patient controlled analgesia with morphine was used for postoperative pain control in liver transplant recipients.

  2. PCA with morphine and ketorolac:

    Patient controlled analgesia with morphine and ketorolac was used for postoperative pain control in liver transplant and thoracic surgery patients.

  3. Intravenous PCA in thoracic surgery Intravenous patient controlled analgesia was used for postoperative pain control in thoracic surgery patients.
  4. PCEA in thoracic surgery Patient controlled epidural analgesia was used for postoperative pain control in thoracic surgery patients.
Other Names:
  • morphine
  • ketorolac
  • marcaine

Intravenous PCA in thoracic surgery
Intravenous patient controlled analgesia was used for postoperative pain control in thoracic surgery patients.
Drug: Patient controlled analgesia
  1. PCA with morphine in liver transplant:

    Intravenous patient controlled analgesia with morphine was used for postoperative pain control in liver transplant recipients.

  2. PCA with morphine and ketorolac:

    Patient controlled analgesia with morphine and ketorolac was used for postoperative pain control in liver transplant and thoracic surgery patients.

  3. Intravenous PCA in thoracic surgery Intravenous patient controlled analgesia was used for postoperative pain control in thoracic surgery patients.
  4. PCEA in thoracic surgery Patient controlled epidural analgesia was used for postoperative pain control in thoracic surgery patients.
Other Names:
  • morphine
  • ketorolac
  • marcaine

PCEA in thoracic surgery
Patient controlled epidural analgesia was used for postoperative pain control in thoracic surgery patients.
Drug: Patient controlled analgesia
  1. PCA with morphine in liver transplant:

    Intravenous patient controlled analgesia with morphine was used for postoperative pain control in liver transplant recipients.

  2. PCA with morphine and ketorolac:

    Patient controlled analgesia with morphine and ketorolac was used for postoperative pain control in liver transplant and thoracic surgery patients.

  3. Intravenous PCA in thoracic surgery Intravenous patient controlled analgesia was used for postoperative pain control in thoracic surgery patients.
  4. PCEA in thoracic surgery Patient controlled epidural analgesia was used for postoperative pain control in thoracic surgery patients.
Other Names:
  • morphine
  • ketorolac
  • marcaine




Primary Outcome Measures :
  1. lung injury score [ Time Frame: four days ]

Biospecimen Retention:   Samples Without DNA
plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
End stage liver disease Lung cancer
Criteria

Inclusion Criteria:

  • End stage liver disease patients scheduled for liver transplantation in National Taiwan University Hospital
  • Lung cancer patients scheduled for thoracic surgery in National Taiwan University Hospital

Exclusion Criteria:

  • preoperative pulmonary dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01932918


Locations
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Taiwan
Department of Anesthesiology, NTUH, Taipei, Taiwan
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Kuang Cheng Chan, M.D. Department of Anesthesiology, NTUH, Taipei, Taiwan
Publications:
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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01932918    
Other Study ID Numbers: 201001020R
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: July 23, 2015
Last Verified: July 2015
Keywords provided by National Taiwan University Hospital:
reactive oxygen species
ischemia reperfusion injury
Additional relevant MeSH terms:
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Liver Diseases
End Stage Liver Disease
Reperfusion Injury
Ischemia
Pathologic Processes
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Liver Failure
Hepatic Insufficiency
Ketorolac
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action