NCT01932918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

4.5 years

First QC Date

August 27, 2013

Last Update Submit

July 21, 2015

Conditions

Keywords

reactive oxygen speciesischemia reperfusion injury

Outcome Measures

Primary Outcomes (1)

  • lung injury score

    four days

Study Arms (4)

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

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

Intravenous PCA in thoracic surgery

Intravenous patient controlled analgesia was used for postoperative pain control in thoracic surgery patients.

Drug: Patient controlled analgesia

PCEA in thoracic surgery

Patient controlled epidural analgesia was used for postoperative pain control in thoracic surgery patients.

Drug: Patient controlled analgesia

Interventions

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.

Also known as: morphine, ketorolac, marcaine
Intravenous PCA in thoracic surgeryPCA with ketorolac in liver transplantPCA with morphine in liver transplantPCEA in thoracic surgery

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

End stage liver disease Lung cancer

You may qualify if:

  • 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

You may not qualify if:

  • preoperative pulmonary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, NTUH, Taipei, Taiwan

Taipei, Taiwan

Location

Related Publications (1)

  • Lin TF, Yeh YC, Lin FS, Wang YP, Lin CJ, Sun WZ, Fan SZ. Effect of combining dexmedetomidine and morphine for intravenous patient-controlled analgesia. Br J Anaesth. 2009 Jan;102(1):117-22. doi: 10.1093/bja/aen320. Epub 2008 Nov 5.

    PMID: 18987053BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

End Stage Liver DiseaseLung NeoplasmsReperfusion Injury

Interventions

Analgesia, Patient-ControlledMorphineKetorolacBupivacaine

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and AnalgesiaMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsIndomethacinIndolesHeterocyclic Compounds, 2-RingAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Kuang Cheng Chan, M.D.

    Department of Anesthesiology, NTUH, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2013

First Posted

August 30, 2013

Study Start

January 1, 2011

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations