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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by National Cheng-Kung University Hospital
Sponsor:
Information provided by (Responsible Party):
Yen Chin Liu, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier:
NCT01919034
First received: July 26, 2013
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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

Condition
Pain
Huntington Disease
Hepatic Surgery

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Evaluating the Relationship of Morphine Consumption and Pain-related Molecules in Hepatic Surgical Patients

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • consumption of morphine for patients undergoing hepatic surgery [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • various pain models of TM in tissues [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
    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).

  • HD over-expressed mice and pain behavior [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
    The investigators will work on HD over-expressed mice and pain behavior with morphine.

  • Change of IL-20 after morphine administration [ Time Frame: 20 months ] [ Designated as safety issue: Yes ]
    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.


Biospecimen Retention:   Samples Without DNA

blood will be sampling (15cc/time), iver tissue (10mm3)


Estimated Enrollment: 40
Study Start Date: April 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01919034

Contacts
Contact: Yen-Chin Liu, Doctor +886-62353535 ext 5348 anesliu@gmail.com

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan City, Shengli Rd, Taiwan, 701
Contact: Yen-Chin Liu, Doctor    +886-62353535 ext 5348    anesliu@gmail.com   
Principal Investigator: Yen-Chin Liu, Doctor         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Study Chair: Yen-Chin Liu, Doctor Department of Anesthesiology, National Cheng-Kung University Hospital
  More Information

No publications provided

Responsible Party: Yen Chin Liu, Visiting Staff, Department of Anesthesiology Chief, National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT01919034     History of Changes
Other Study ID Numbers: B-ER-102-026
Study First Received: July 26, 2013
Last Updated: August 6, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Cheng-Kung University Hospital:
Interleukin-20, Thrombomodulin, Huntington disease, patient control analgesic

Additional relevant MeSH terms:
Chorea
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Morphine
Analgesics
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014