Postoperative PainNCT01758809
Pain Control of Thoracoscopic Major Pulmonary Resection
A study testing Pre-emptive bupivacaine wound infiltration in people with Postoperative Pain, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pre-emptive bupivacaine wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2010to Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity
Who cannot join
- not done by VATS anatomical resection
- patient does not agree to the study
- postoperative hospital stay exceeds 7 days due to postoperative complications
- existence of preoperative renal insufficiency (Cr > 1.5)
- OT/PT > 120
- history of Lidocaine hypersensitivity
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?
The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
Read the detailed description
Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
- Conditions
- Postoperative Pain
- Being tested
- Pre-emptive bupivacaine wound infiltration, intravenous patient controlled analgesia
- Keywords
- Video Assisted Thoracic Surgery, Postoperative Pain, Intravenous Patient Controlled Analgesia, Bupivacaine, Major Pulmonary Resection, Post Pulmonary Resection
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-emptive bupivacaine wound infiltrationProcedure or surgery
Pre-emptive bupivacaine wound infiltration
intravenous patient controlled analgesiaProcedure or surgery
postoperative pain control with intravenous patient controlled analgesia
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Not described Receives: Procedure: Pre-emptive bupivacaine wound infiltration |
| Intravenous Patient Controlled Analgesia | Other | postoperative pain control with intravenous patient controlled analgesia Receives: Procedure: intravenous patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in postoperative pain confirmed by Visual Analogue Pain Scale
Measured: Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months
Secondary outcomes (1)
number of participants with adverse events related to fentanyl or bupivacaine drug
nausea, vomiting, sleepiness, urinary difficulty, respiratory depression
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2013 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanghoon Jheon, Seoul National University Bundang Hospital
- Investigators
- Sanghoon Jheon, M.D., Ph.D., Study chair, Seoul National University Bundang HospitalHee Chul Yang, M.D., Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01758809
- Sponsor's protocol ID
- B-1009-111-015
- Status last verified
- Dec 2012
- First submitted
- 28 Sep 2011
- Last updated
- 1 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Control of Thoracoscopic Major Pulmonary Resection: Is Pre-emptive Local Bupivacaine Injection Able to Replace the Intravenous Patient Controlled Analgesia?
- ClinicalTrials.gov ID
- NCT01758809
- Acronym / sponsor ID
- B-1009-111-015
- Conditions
- Postoperative Pain
- Keywords
- Video Assisted Thoracic Surgery, Postoperative Pain, Intravenous Patient Controlled Analgesia, Bupivacaine, Major Pulmonary Resection, Post Pulmonary Resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Jan 2013 (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 whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
Detailed description
Despite less postoperative pain from Video Assisted Thoracic Surgery (VATS) than thoracotomy, pain is still an important issue in its recovery period. After VATS procedure, intravenous patient controlled analgesia (IV PCA) is being used for pain control. However, the side effects of IV PCA are nausea, vomiting, sleepiness, and urination difficulty which interrupt the early recovery. It is established that pre-emptive local bupivacaine injection is more economical, has almost no side effects, and finally, it is effective for the postoperative 24 hours. The purpose of this study is to evaluate whether pre-emptive local bupivacaine injection is a better alternative pain control modality than the conventional intravenous patient controlled analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Procedure: Pre-emptive bupivacaine wound infiltration |
| Intravenous Patient Controlled Analgesia | Other | Procedure: intravenous patient controlled analgesiapostoperative pain control with intravenous patient controlled analgesia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients that are expected to receive VATS segmenectomy or lobectomy regardless of disease entity
Key exclusion criteria (6 listed)
- not done by VATS anatomical resection
- patient does not agree to the study
- postoperative hospital stay exceeds 7 days due to postoperative complications
- existence of preoperative renal insufficiency (Cr > 1.5)
- OT/PT > 120
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 |
|---|---|---|
| Pre-emptive bupivacaine wound infiltrationPre-emptive bupivacaine wound infiltration | Procedure or surgery | Bupivacaine |
| intravenous patient controlled analgesiapostoperative pain control with intravenous patient controlled analgesia | Procedure or surgery | Intravenous Patient Controlled Analgesia |
Primary outcome
The change in postoperative pain confirmed by Visual Analogue Pain Scale
Time frame: Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months
1 secondary outcome
number of participants with adverse events related to fentanyl or bupivacaine drug
Time frame: 2 months
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 1 Jan 2013.
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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.
Sanghoon Jheon, M.D., Ph.D. study chair
Seoul National University Bundang Hospital
Hee Chul Yang, M.D. principal investigator
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-emptive bupivacaine wound infiltration in people with Postoperative Pain, run by Seoul National University Bundang 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 6 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 1 Jan 2013. 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?
The change in postoperative pain confirmed by Visual Analogue Pain Scale (time frame: Operation day, Postoperative Day 1, 2, 3 and 2 week, 1 month, 2 months). 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 1 Jan 2013.