Antinociceptive Modalities on Ischemia Reperfusion Injury

July 21, 2015 updated by: National Taiwan University Hospital

The Interaction of Nociceptive Stimulation and Various Antinociceptive Modalities on Ischemia Reperfusion Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

142

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Department of Anesthesiology, NTUH, Taipei, Taiwan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

End stage liver disease Lung cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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:
  • ketorolac
  • morphine
  • 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:
  • ketorolac
  • morphine
  • 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:
  • ketorolac
  • morphine
  • 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:
  • ketorolac
  • morphine
  • marcaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lung injury score
Time Frame: four days
four days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 27, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

July 23, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201001020R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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