PainVATS_IMNCT00639795
Study of the Effect of Regional Nerve Blocks on Pain and Inflammation After Video Assisted Thorascopic Lung Surgery
A study testing Thoracic Paravertebral Nerve Block in people with Pain, run by Memorial Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare: 1. The degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain 2. The degree of pain and nausea and 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Thoracic Paravertebral Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18
- Planned thoracoscopy with low probability(by surgeon estimate) of conversion to open procedure
Who cannot join
- Age less than 18
- Clinical or laboratory evidence of systemic infection
- Current pregnancy as assessed by preoperative urine HCG test
- Serious, uncontrolled, non-malignant illness
- Malignant illness requiring systemic chemotherapy in the last 6 months
- Documented allergy to oxycodone, morphine sulfate or acetaminophen
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- Contraindication to peripheral nerve blockade or general anesthesia including:
- patient refusal
- active infection at site of planned block
- documented allergy to any local or general anesthetic medications
- significant coagulopathy( prothrombin time >15 seconds, INR>1.5
- pre-existing neuropathy and medical conditions or deformities which would compromise block or anesthetic safety
- Planned pleurodesis
- Current use of high dose inhaled or systemic steroids
- Current use of Amiodarone (Cordarone)
- Morbid obesity (BMI=40kg/m2)
- Patients with clinically significant mental health issues such as psychosis requiring treatment with antipsychotic medications.
- Patients unable to consent
- Patients with active infections requiring antibiotics within one month of registration
- Participation in other clinical trials that may interfere with this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Medical Center
Johnstown, Pennsylvania, 15905
About this study
Official title: Prospective Randomized Trial Evaluating the Effects of Paravertebral Nerve Blocks on Postoperative Pain and the Perioperative Inflammatory Response Following Video Assisted Thorascopic Surgery
The purpose of this study is to compare:
- The degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain
- The degree of pain and nausea and
- The pre and post operative pulmonary functions following Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with the addition of intra-operative single-injection paravertebral blockade vs general anesthesia with a sham intra-operative paravertebral nerve blockade
Read the detailed description
- Enrolled subjects scheduled to undergo video-assisted thorascopic surgery (VATS) will be randomized to receive either paravertebral block or placebo(adhesive bandage applied at the site).
- All patients will undergo a standardized general anesthetic regimen.
- Human biological specimens will be collected preoperatively, postoperatively (in the PACU) at the first morning blood draw of POD 1, POD 2, POD 3, and POD 10-14 (follow-up visit at surgeons office)and analyzed for CRP, Cortisol \& inflammatory markers (IL-1beta,IL-2,IL-4,IL-5,IL-6, IL-8, IL-10,INF-gamma, TNF-alpha)
- Pulmonary functions (FEV1/FEV6) will be performed in the pre-op holding area prior to sedation and post-operatively on the morning of post-op day 1.
- Pain levels will be assessed with the Wong-Baker Faces and Visual Analog Scale pre-operatively in the PACU and hourly for a total of 6 hours and then every 8 hrs.and with patient self-report in diary after discharge.
- Pain levels will be assessed with the McGill-Melzack Pain Questionnaire pre-operatively, the evening of POD1-POD3 and by patient self-report in diary after discharge.
- Nausea assessments will occur at arrival on floor and every 8 hours thereafter until discharge.
- Narcotic requirements will be collected daily in the hospital and by patient self report in diary thereafter.
- Conditions
- Pain
- Being tested
- Thoracic Paravertebral Nerve Block
- Keywords
- Thoracic paravertebral block, Cytokines, Video assisted thorascopic surgery, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic Paravertebral Nerve BlockProcedure or surgery
Also called VATS IM, Thoracic Peripheral Nerve Blockade
One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia
Thoracic Paravertebral Nerve BlockProcedure or surgery
Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients randomized to receive thoracic paravertebral nerve blockade in addition to general endotracheal anesthesia during video assisted thoracoscopy procedure Receives: Procedure: Thoracic Paravertebral Nerve Block |
| B | Sham comparator | Patients randomized to receive sham single-injection thoracic peripheral nerve blockade (no injection) in addition to general endotracheal anesthesia Receives: Procedure: Thoracic Paravertebral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain
Measured: 1 year
Secondary outcomes (1)
To compare the degree of pain and nausea
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: inadequate sample population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine, U.S. Army Medical Research and Development Command
- Investigators
- William T Fritz, MD, Principal investigator, Memorial Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639795
- Sponsor's protocol ID
- A-13101.2 MMC 06-28
- Other IDs
- Proposal Log Number 04070001, Award Number W81XWH-05-1-0047
- Acronym
- VATS_IM
- Status last verified
- Jul 2013
- First submitted
- 14 Mar 2008
- Last updated
- 3 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Evaluating the Effects of Paravertebral Nerve Blocks on Postoperative Pain and the Perioperative Inflammatory Response Following Video Assisted Thorascopic Surgery
- ClinicalTrials.gov ID
- NCT00639795
- Acronym / sponsor ID
- VATS_IM / A-13101.2 MMC 06-28
- Conditions
- Pain
- Keywords
- Thoracic paravertebral block, Cytokines, Video assisted thorascopic surgery, Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inadequate sample population
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Memorial Medical CenterUniversity, hospital or other
- Collaborators
- Henry M. Jackson Foundation for the Advancement of Military Medicine, U.S. Army Medical Research and Development Command
- Study start
- Mar 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 20 Mar 2008 (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 degree of systemic postoperative inflammation (cytokine measurement) with the degree of post-operative pain
- The degree of pain and nausea and
- The pre and post operative pulmonary functions following Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with the addition of intra-operative single-injection paravertebral blockade vs general anesthesia with a sham intra-operative paravertebral nerve blockade
Detailed description
- Enrolled subjects scheduled to undergo video-assisted thorascopic surgery (VATS) will be randomized to receive either paravertebral block or placebo(adhesive bandage applied at the site).
- All patients will undergo a standardized general anesthetic regimen.
- Human biological specimens will be collected preoperatively, postoperatively (in the PACU) at the first morning blood draw of POD 1, POD 2, POD 3, and POD 10-14 (follow-up visit at surgeons office)and analyzed for CRP, Cortisol \& inflammatory markers (IL-1beta,IL-2,IL-4,IL-5,IL-6, IL-8, IL-10,INF-gamma, TNF-alpha)
- Pulmonary functions (FEV1/FEV6) will be performed in the pre-op holding area prior to sedation and post-operatively on the morning of post-op day 1.
- Pain levels will be assessed with the Wong-Baker Faces and Visual Analog Scale pre-operatively in the PACU and hourly for a total of 6 hours and then every 8 hrs.and with patient self-report in diary after discharge.
- Pain levels will be assessed with the McGill-Melzack Pain Questionnaire pre-operatively, the evening of POD1-POD3 and by patient self-report in diary after discharge.
- Nausea assessments will occur at arrival on floor and every 8 hours thereafter until discharge.
- Narcotic requirements will be collected daily in the hospital and by patient self report in diary thereafter.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Thoracic Paravertebral Nerve BlockPatients randomized to receive thoracic paravertebral nerve blockade in addition to general endotracheal anesthesia during video assisted thoracoscopy procedure |
| B | Sham comparator | Procedure: Thoracic Paravertebral Nerve BlockPatients randomized to receive sham single-injection thoracic peripheral nerve blockade (no injection) in addition to general endotracheal anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than 18
- Planned thoracoscopy with low probability(by surgeon estimate) of conversion to open procedure
Key exclusion criteria (20 listed)
- Age less than 18
- Clinical or laboratory evidence of systemic infection
- Current pregnancy as assessed by preoperative urine HCG test
- Serious, uncontrolled, non-malignant illness
- Malignant illness requiring systemic chemotherapy in the last 6 months
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 Paravertebral Nerve BlockAlso: VATS IM, Thoracic Peripheral Nerve BlockadeOne Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia | Procedure or surgery | A |
| Thoracic Paravertebral Nerve BlockSham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia | Procedure or surgery | B |
Primary outcome
Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain
Time frame: 1 year
1 secondary outcome
To compare the degree of pain and nausea
Time frame: 1 year
Results and safety
The study was stopped early (reason given: inadequate sample population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 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.
William T Fritz, MD principal investigator
Memorial Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Paravertebral Nerve Block in people with Pain, run by Memorial Medical Center 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 20 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 3 Jul 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 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: inadequate sample population). 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?
Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain (time frame: 1 year). 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 3 Jul 2013.