Postoperative Pain After Video Assisted Thoracic SurgeryNCT01538914
Analgesic Effect of Intravenous Patient-Controlled Analgesia (IV PCA) Versus Paravertebral Block After Video Assisted Thoracic Surgery (VATS)
A study testing paravertebral block and PCA in people with Postoperative Pain After Video Assisted Thoracic Surgery, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the analgesic effect of paravertebral block with that of intravenous patient-controlled analgesia after video assisted thoracic surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Postoperative Pain After Video Assisted Thoracic Surgery
- What is being tested?
- paravertebral block and PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Oct 2015
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients receiving video assisted thoracic surgery
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 VATS
- patients with pain at the expected incision site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between the Analgesic Effect of Intravenous Patient-controlled Analgesia and of Paravertebral Block After Video Assisted Thoracoscopic Surgery
The purpose of this study is to compare the analgesic effect of paravertebral block with that of intravenous patient-controlled analgesia after video assisted thoracic surgery.
- Being tested
- paravertebral block, PCA
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 via PVB.
PCAProcedure or surgery
Postoperative pain is controlled with intravenous PCA.
| Study group | Role | What they receive |
|---|---|---|
| PVB | Experimental | Postoperative pain is controlled with local analgesics delivered via PVB. Receives: Procedure: paravertebral block |
| PCA | Active comparator | Postoperatve pain is controlled with intravenous PCA. Receives: Procedure: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of acute postoperative pain when moving
Measured: 24 hours after VATS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startFeb 2013
- Primary completionFeb 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain After Video Assisted Thoracic SurgeryStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538914
- Sponsor's protocol ID
- JHBahk_VATS PVB
- Status last verified
- Apr 2016
- First submitted
- 16 Feb 2012
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between the Analgesic Effect of Intravenous Patient-controlled Analgesia and of Paravertebral Block After Video Assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT01538914
- Acronym / sponsor ID
- JHBahk_VATS PVB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 24 Feb 2012 (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 compare the analgesic effect of paravertebral block with that of intravenous patient-controlled analgesia after video assisted thoracic surgery.
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 blockPostoperative pain is controlled with local analgesics delivered via PVB. |
| PCA | Active comparator | Procedure: PCAPostoperatve pain is controlled with intravenous PCA. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients receiving video assisted thoracic surgery
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 VATS
- 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 via PVB. | Procedure or surgery | PVB |
| PCAPostoperative pain is controlled with intravenous PCA. | Procedure or surgery | PCA |
Primary outcome
severity of acute postoperative pain when moving
Time frame: 24 hours after VATS
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 Apr 2016.
Related trials for Postoperative Pain After Video Assisted Thoracic Surgery
RecruitingObservational study
Sensory Anesthesia Achieved Through Different Paravertebral Block Approaches for Post-Op Pain Management After VATS Lung Resection
Thoracic Surgery, Video-assisted
RecruitingPhase 4
Comparison of the Efficacy and Safety of Intravenous Buprenorphine Administered Via PCA System Versus Oxycodone in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery
Acute Postoperative Pain, Chronic Postoperative Pain
Recruiting
ESPB Versus SPSIPB for Quality of Recovery After Video-Assisted Thoracoscopic Surgery
Postoperative Pain
Recruiting
Pre-incisional Infiltration With Ropivacaine Plus Triamcinolone for Relieving Postoperative Pain After Thoracoscopic Surgery
Video-assisted Thoracoscopic Surgery (VATS), Wedge Resection
Recruiting
Transcutaneous Electrical Nerve Stimulation for Acute Postoperative Pain After Video-Assisted Thoracoscopic Surgery
Acute Postoperative Pain, Thoracic Surgical Procedures
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 PCA in people with Postoperative Pain After Video Assisted Thoracic Surgery, 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 Apr 2016. 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?
severity of acute postoperative pain when moving (time frame: 24 hours after VATS). 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 Apr 2016.