THoracotomyPhase 1NCT00373633
Extrapleural Intercostal Catheter vs. Thoracic Epidural for Thoracotomy Pain
A Phase 1 study testing Thoracic Epidural and Extrapleural Intercostal Catheter in people with THoracotomy, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- THoracotomy
- What is being tested?
- Thoracic Epidural and Extrapleural Intercostal Catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Jan 2012
- Phase
- Phase 1
- 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
Who may be able to join
- Unilateral thoracotomy
- Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy
Who cannot join
- Bilateral thoracotomy
- Planned bilateral thoracotomy
- Planned chest wall resection
- Planned combined thoracotomy and laparotomy procedure
- VATS procedure without conversion to unilateral thoracotomy
- Emergency operation
Show all 16Show fewer
- Critically ill patients
- Patients who require an assistive device (i.e. cane, walker, or wheel chair) for mobility
- Patients who are unable to give informed consent
- Patients with preoperative chronic back or chest wall pain
- Empyema or other infective condition increasing the risk of epidural infection
- Coagulopathy
- Decision of the surgeon or anesthesiologist, or choice of the patient
- Infection at site of epidural placement
- Patients with other co morbidities which exclude thoracic epidural placement
- Patients under the age of 18 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.
Read the detailed description
The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups[Figure 1]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an "equivalence study". The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.
- Conditions
- THoracotomy
- Being tested
- Thoracic Epidural, Extrapleural Intercostal Catheter
- Keywords
- THoracic Surgery, thoracic epidural, epidural, thoracotomy, intercostal nerve block, intercostal, nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic EpiduralProcedure or surgery
Gold standard for post thoracotomy pain
Extrapleural Intercostal CatheterProcedure or surgery
Continuous extra-pleural intercostal local anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Continuous extra-pleural intercostal local anesthesia | Experimental | intra-operatively placed extrapleural intercostal catheter Receives: Procedure: Extrapleural Intercostal Catheter |
| Thoracic Epidural | Active comparator | gold standard Receives: Procedure: Thoracic Epidural |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain control-visual analog pain score
Measured: post surgery monitoring
Secondary outcomes (1)
respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities
Measured: post surgery monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: terminated due to diminishing frequency of thorocotomies and slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for THoracotomyStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- I-Flow
- Responsible party
- Sponsor
- Investigators
- Mark Nelson, MD, Principal investigator, Virgina Commonwealth University, Dept of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00373633
- Sponsor's protocol ID
- VCU 011906
- Status last verified
- Aug 2014
- First submitted
- 6 Sep 2006
- Last updated
- 15 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Comparing Extrapleural Intercostal Local Anesthesia Versus Thoracic Epidural for the Managment of Acute Post Thoracotomy Pain
- ClinicalTrials.gov ID
- NCT00373633
- Acronym / sponsor ID
- VCU 011906
- Conditions
- THoracotomy
- Keywords
- THoracic Surgery, thoracic epidural, epidural, thoracotomy, intercostal nerve block, intercostal, nerve block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to diminishing frequency of thorocotomies and slow enrollment
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- I-Flow
- Study start
- Sep 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Sep 2006 (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.
We will compare thoracic epidural anesthesia which is presently used for management of pain after thoracotomy to an intra-operatively placed extrapleural intercostal catheter. The study wil be double blinded and prospective.
Detailed description
The aim of this study is to evaluate the efficacy of thoracic epidural vs. continuous extra-pleural intercostal local anesthesia for the treatment of post thoracotomy pain in adult patients. Study patients will be randomized between the thoracic epidural and continuous extrapleural catheter groups[Figure 1]. Because thoracic epidural anesthesia is the gold standard but continuous extrapleural intercostal local anesthesia is potentially easier and less prone to complications, the study will be structured as an "equivalence study". The null hypothesis (Ho) is that continuous intercostal nerve blockade is worse than epidural for post-thoracotomy pain management. Therefore, the alternative hypothesis (Ha) is then that continuous intercostal nerve blockade is equal to or better than epidural for post-thoracotomy pain management.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous extra-pleural intercostal local anesthesia | Experimental | Procedure: Extrapleural Intercostal Catheterintra-operatively placed extrapleural intercostal catheter |
| Thoracic Epidural | Active comparator | Procedure: Thoracic Epiduralgold standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Unilateral thoracotomy
- Video Assisted thoracotomy with high likely hood of converting to open thoracotmoy
Key exclusion criteria (16 listed)
- Bilateral thoracotomy
- Planned bilateral thoracotomy
- Planned chest wall resection
- Planned combined thoracotomy and laparotomy procedure
- VATS procedure without conversion to unilateral thoracotomy
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 |
|---|---|---|
| Thoracic EpiduralGold standard for post thoracotomy pain | Procedure or surgery | Thoracic Epidural |
| Extrapleural Intercostal CatheterContinuous extra-pleural intercostal local anesthesia | Procedure or surgery | Continuous extra-pleural intercostal local anesthesia |
Primary outcome
pain control-visual analog pain score
Time frame: post surgery monitoring
1 secondary outcome
respiratory measurements (FEV1, PEF), pain score, nausea and vomiting, opiod usage as adjunct to primary treatmetn modalities
Time frame: post surgery monitoring
Results and safety
The study was stopped early (reason given: terminated due to diminishing frequency of thorocotomies and slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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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.
Mark Nelson, MD principal investigator
Virgina Commonwealth University, Dept of Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Thoracic Epidural and Extrapleural Intercostal Catheter in people with THoracotomy, run by Virginia Commonwealth University at 1 site in United States.
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 2 inclusion and 16 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: stopped early, as of the sponsor's last update on 15 Aug 2014. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated due to diminishing frequency of thorocotomies and slow enrollment). 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?
pain control-visual analog pain score (time frame: post surgery monitoring). 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 15 Aug 2014.