- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00935571
Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia
July 8, 2009 updated by: Asan Medical Center
The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Thoracotomy is one of the most painful surgical incisions.
It has been shown that 5-80% of patients still suffer from thoracic pain 2-3 months after surgery and the international association for the study of pain (IASP) defines postthoracotomy pain syndrome (PTTS)as pain that recurs or persists at least 2 months after surgical procedure.
Previous reports have shown that the incidence of PTTS varies according to preoperative pain, pain intensity, sex, and types of procedure.
However, little is known about the effect of the type of anesthesia to postthoracotomy pain.
Study Type
Observational
Enrollment (Anticipated)
400
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
-
-
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Seoul, Korea, Republic of, 138-736
- Department of Anesthesiology and Pain Medicine, University of Ulsan College of Medicine, Asan Medical Center
-
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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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients scheduled to undergo elective thoracotomy of lung surgery
Description
Inclusion Criteria:
- patients undergo elective thoracotomy of lung surgery
Exclusion Criteria:
- emergency operation age under 18 years patients with unstable hemodynamics
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
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group I, Group II
Group I: anesthetized with TIVA (Propofol + Remifentanil) Group II: anesthetized with inhalation (sevoflurane) |
Propofol: using target controlled infusion (TCI); 1-3ug/ml remifentanil: using TCI by 5-20 ng/ml sevoflurane: 2-3volume% (1-2 MAC)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of pain
Time Frame: 3 and 6 months later after operation
|
3 and 6 months later after operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
pain characters
Time Frame: 3 and 6 months later after operation
|
3 and 6 months later after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: In Cheol Choi, MD, PhD, Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine
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.
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
October 1, 2007
Primary Completion (Anticipated)
June 1, 2009
Study Completion (Anticipated)
September 1, 2009
Study Registration Dates
First Submitted
July 8, 2009
First Submitted That Met QC Criteria
July 8, 2009
First Posted (Estimate)
July 9, 2009
Study Record Updates
Last Update Posted (Estimate)
July 9, 2009
Last Update Submitted That Met QC Criteria
July 8, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Platelet Aggregation Inhibitors
- Analgesics, Opioid
- Narcotics
- Hypnotics and Sedatives
- Anesthetics, Inhalation
- Remifentanil
- Propofol
- Sevoflurane
Other Study ID Numbers
- 20090708
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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