Lung CancerNCT00935571
Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia
An observational study of Lung Cancer and Neoplasms, Lung, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Neoplasms, Lung
- What is being tested?
- propofol, remifentanil, sevoflurane
- Type of treatment
- Injection or infusion
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2007to Sep 2009
- 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 scheduled to undergo elective thoracotomy of lung surgery
Who may be able to join
- patients undergo elective thoracotomy of lung surgery
Who cannot join
- emergency operation age under 18 years patients with unstable hemodynamics
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, University of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
About this study
The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.
Read the 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.
- Conditions
- Lung Cancer, Neoplasms, Lung
- Being tested
- propofol, remifentanil, sevoflurane
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofol, remifentanil, sevofluraneDrug
Also called diprivan, ultiva
Propofol: using target controlled infusion (TCI); 1-3ug/ml remifentanil: using TCI by 5-20 ng/ml sevoflurane: 2-3volume% (1-2 MAC)
| Study group | Role | What they receive |
|---|---|---|
| Group I, Group II | Group I: anesthetized with TIVA (Propofol + Remifentanil)
Group II: anesthetized with inhalation (sevoflurane) Receives: Drug: propofol, remifentanil, sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pain
Measured: 3 and 6 months later after operation
Secondary outcomes (1)
pain characters
Measured: 3 and 6 months later after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startOct 2007
- Primary completionJun 2009 (estimated)
- Study completionSep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- In Cheol Choi, MD, PhD, Study chair, Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935571
- Sponsor's protocol ID
- 20090708
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 9 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.
PubMed 11394926
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postthoracotomy Pain Following General Anesthesia: A Comparison Between TIVA and Inhalation Anesthesia
- ClinicalTrials.gov ID
- NCT00935571
- Acronym / sponsor ID
- 20090708
- Conditions
- Lung Cancer, Neoplasms, Lung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2009 (estimated)
- First posted
- 9 Jul 2009 (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.
The purpose of this study is to evaluate the incidence of postthoracotomy pain between total intravenous anesthesia (TIVA)and inhalation anesthesia after lung surgery.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group I, Group II | – | Drug: propofol, remifentanil, sevofluraneGroup I: anesthetized with TIVA (Propofol + Remifentanil) Group II: anesthetized with inhalation (sevoflurane) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled to undergo elective thoracotomy of lung surgery
Key inclusion criteria (1 listed)
- patients undergo elective thoracotomy of lung surgery
Key exclusion criteria (1 listed)
- emergency operation age under 18 years patients with unstable hemodynamics
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| propofol, remifentanil, sevofluraneAlso: diprivan, ultivaPropofol: using target controlled infusion (TCI); 1-3ug/ml remifentanil: using TCI by 5-20 ng/ml sevoflurane: 2-3volume% (1-2 MAC) | Drug | Group I, Group II |
Primary outcome
Incidence of pain
Time frame: 3 and 6 months later after operation
1 secondary outcome
pain characters
Time frame: 3 and 6 months later after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2009.
- Background: PubMed 11394926Gotoda Y, Kambara N, Sakai T, Kishi Y, Kodama K, Koyama T. The morbidity, time course and predictive factors for persistent post-thoracotomy pain. Eur J Pain. 2001;5(1):89-96. doi: 10.1053/eujp.2001.0225.
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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.
In Cheol Choi, MD, PhD study chair
Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan College of Medicine
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 Lung Cancer and Neoplasms, Lung, run by Asan Medical Center at 1 site in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 9 Jul 2009. 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 South Korea. 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?
Results are not available in the source record.
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?
Incidence of pain (time frame: 3 and 6 months later after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00935571, which also lists 1 linked publication.
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 9 Jul 2009.