Acute Postthoracotomy PainNCT01039870
The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain
A study testing paravertebral block and thoracic epidural analgesia in people with Acute Postthoracotomy Pain and Chronic Postthoracotomy Pain, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study aims to evaluate the effect of the paravertebral block using a multi-lumen catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to the thoracic epidural block. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Acute Postthoracotomy Pain, Chronic Postthoracotomy Pain, Hypotension After Bolus Dose
- What is being tested?
- paravertebral block and thoracic epidural analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Feb 2012
- Phase
- Interventional
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving surgery through a thoracotomy incision
Who cannot join
- patients with cardiovascular disease
- patients with neurologic disease
- patients with contraindications to paravertebral block or epidural block
- patients with history of previous thoracotomy incision
- patients with pain at the expected incision site
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 110-744
About this study
This study aims to evaluate the effect of the paravertebral block using a multi-lumen catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to the thoracic epidural block.
- Being tested
- paravertebral block, thoracic epidural analgesia
- Keywords
- postthoracotomy pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paravertebral blockProcedure or surgery
postoperative pain is controlled with local analgesics delivered via PVB
thoracic epidural analgesiaProcedure or surgery
postoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter
| Study group | Role | What they receive |
|---|---|---|
| PVB | Experimental | Paravertebral block initiated at the later part of thoracotomy is used for postoperative pain control Receives: Procedure: paravertebral block |
| TEA | Active comparator | Thoracic epidural block initiated before the surgical incision is used for postoperative pain control. Receives: Procedure: thoracic epidural analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of acute postthoracotomy pain when moving
Measured: 24 hours after thoracotomy
Secondary outcomes (1)
Incidence of chronic postthoracotomy pain
Measured: 6 months after thoracotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2009 (estimated)
- Study startJul 2010
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Postthoracotomy PainStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01039870
- Sponsor's protocol ID
- YTKim_PVB_Postthor Pain
- Status last verified
- Feb 2012
- First submitted
- 23 Dec 2009
- Last updated
- 20 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain
- ClinicalTrials.gov ID
- NCT01039870
- Acronym / sponsor ID
- YTKim_PVB_Postthor Pain
- Keywords
- postthoracotomy pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Dec 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.
This study aims to evaluate the effect of the paravertebral block using a multi-lumen catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to the thoracic epidural block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVB | Experimental | Procedure: paravertebral blockParavertebral block initiated at the later part of thoracotomy is used for postoperative pain control |
| TEA | Active comparator | Procedure: thoracic epidural analgesiaThoracic epidural block initiated before the surgical incision is used for postoperative pain control. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving surgery through a thoracotomy incision
Key exclusion criteria (5 listed)
- patients with cardiovascular disease
- patients with neurologic disease
- patients with contraindications to paravertebral block or epidural block
- patients with history of previous thoracotomy incision
- patients with pain at the expected incision site
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 |
|---|---|---|
| paravertebral blockpostoperative pain is controlled with local analgesics delivered via PVB | Procedure or surgery | PVB |
| thoracic epidural analgesiapostoperative pain is controlled with local analgesics and fentanyl delivered via thoracic epidural catheter | Procedure or surgery | TEA |
Primary outcome
Incidence and severity of acute postthoracotomy pain when moving
Time frame: 24 hours after thoracotomy
1 secondary outcome
Incidence of chronic postthoracotomy pain
Time frame: 6 months after thoracotomy
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 20 Feb 2012.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paravertebral block and thoracic epidural analgesia in people with Acute Postthoracotomy Pain and Chronic Postthoracotomy Pain, run by Seoul National University Hospital 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 5 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 20 Feb 2012. 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?
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?
Incidence and severity of acute postthoracotomy pain when moving (time frame: 24 hours after thoracotomy). 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 20 Feb 2012.