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

NCT01919034 | Completed DMC

• 1 other identifier: B-ER-102-026
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain; Huntington Disease; Hepatic Surgery

Keywords

Interleukin-20, Thrombomodulin, Huntington disease, patient control analgesic

Outcome Measures

Primary Outcomes (1)

• 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 will be evaluated for their pain control quality.

  20 months

Secondary Outcomes (3)

• various pain models of TM in tissues

  20 months

• HD over-expressed mice and pain behavior

  20 months

• Change of IL-20 after morphine administration

  20 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Shengli Rd, 701, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Pain; Huntington Disease

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Yen-Chin Liu, Doctor

  Department of Anesthesiology, National Cheng-Kung University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Staff, Department of Anesthesiology Chief

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: August 8, 2013
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

TW (1)