PainNCT01919034
Evaluating the Relationship of Morphine Consumption and Pain-related Molecules in Hepatic Surgical Patients
An observational study of Pain and Huntington Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Huntington Disease, Hepatic Surgery
- How many people
- 15 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing liver surgery and using morphine pain control analgesia (PCA) device will be involved.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
Specific aims
- To investigate the correlation of morphine consumption and the serum amount of IL-20, TM or HD
- To investigate the relationship between IL-20, TM, HD amount in liver tissue and morphine consumption
Read the detailed description
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.
- Conditions
- Pain, Huntington Disease, Hepatic Surgery
- Keywords
- Interleukin-20, Thrombomodulin, Huntington disease, patient control analgesic
- Medical subject headings
- Pain, Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 months
Secondary outcomes (3)
various pain models of TM in tissues
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).
Measured: 20 months
HD over-expressed mice and pain behavior
The investigators will work on HD over-expressed mice and pain behavior with morphine.
Measured: 20 months
Change of IL-20 after morphine administration
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.
Measured: 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen Chin Liu, National Cheng-Kung University Hospital
- Investigators
- Yen-Chin Liu, Doctor, Study chair, Department of Anesthesiology, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919034
- Sponsor's protocol ID
- B-ER-102-026
- Status last verified
- Mar 2018
- First submitted
- 26 Jul 2013
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Relationship of Morphine Consumption and Pain-related Molecules in Hepatic Surgical Patients
- ClinicalTrials.gov ID
- NCT01919034
- Acronym / sponsor ID
- B-ER-102-026
- Conditions
- Pain, Huntington Disease, Hepatic Surgery
- Keywords
- Interleukin-20, Thrombomodulin, Huntington disease, patient control analgesic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To investigate the correlation of morphine consumption and the serum amount of IL-20, TM or HD
- To investigate the relationship between IL-20, TM, HD amount in liver tissue and morphine consumption
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver surgery and using morphine pain control analgesia (PCA) device will be involved.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
consumption of morphine for patients undergoing hepatic surgery
Time frame: 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.
3 secondary outcomes
various pain models of TM in tissues
Time frame: 20 months
HD over-expressed mice and pain behavior
Time frame: 20 months
Change of IL-20 after morphine administration
Time frame: 20 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Chin Liu, Doctor study chair
Department of Anesthesiology, National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Huntington Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
consumption of morphine for patients undergoing hepatic surgery (time frame: 20 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.