Post Minimally Invasive Thorascopic Surgical PainPhase 4NCT02005575
The Effect of Dexamethasone on the Duration and Functionality of Bupivacaine Intercostal Nerve Blockade
A Phase 4 study testing Bupivacaine and Dexamethasone in people with Post Minimally Invasive Thorascopic Surgical Pain, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Minimally Invasive Thorascopic Surgical Pain
- What is being tested?
- Bupivacaine and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Mar 2015
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 - 80 years old of either gender, scheduled for unilateral VATS procedure with Dr. McKenna for resection of lung tumor.
Who cannot join
- ASA IV and above
- Intolerance, allergy, or contraindication to use of any medications used in this study
- Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
- Uncontrolled hypertension (BP > 140/90)
- History of prior ipsilateral thorascopic surgery
- Cardiac arrhythmias particularly prolonged QT syndrome
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- Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
- Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
- Pregnant or lactating women
- Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
- Chronic renal failure ( creatinine > 2.0 mg/dL)
- Liver failure e.g., active cirrhosis
- Alcohol or substance abuse within in the past 3 months
- Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
- Restrictive lung disease (pulmonary fibrosis, myasthenia gravis) or FEV1 or FEV less than 70% of predicted value.
- Type 2 diabetes
- Neuropathic pain
- Chronic opioid consumption (>30mg oxycodone or greater per day)
- Cahexia from any cause
- systemic use of corticosteroids for greater than 2 weeks in the 6 months prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function.
Read the detailed description
Our study proposes two groups of 25 patients undergoing similar VATS surgery with a single surgeon, Dr. R. McKenna, who will receive interoperatively placed intercostal nerve blocks at the same levels. Each group will receive intercostals nerve blocks with one of two different solutions: group one will receive intercostal nerve blocks with only 0.46% bupivacaine (19.5 ml of 0.5% bupivacaine + .5 cc saline), group 2 will receive intercostal blocks with 0.46% bupivacaine and dexamethasone(19.5 ml of 0.5% bupivacaine + .5ml .4% dexamethasone). The patients will have pulmonary lung function objectively assessed by portable spirometry and clinical factors both preoperatively and postoperatively. Our study objective is to examine and quantify the potentially beneficial effects of intercostal nerve blockade prolongation with dexamethasone on postoperative pulmonary function and postoperative recovery.
- Being tested
- Bupivacaine and Dexamethasone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine and DexamethasoneDrug
Also called Decadron
The standard of care is to use a regional block solution containing both decadron and bupivicaine.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline) Receives: Drug: Placebo |
| Group 2 | Active comparator | an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone) Receives: Drug: Bupivacaine and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
Patients will be evaluated for post operative pain using the NRS pain evaulation
Measured: 72 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Minimally Invasive Thorascopic Surgical 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dermot Maher, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005575
- Sponsor's protocol ID
- Pro00032069
- Status last verified
- Feb 2015
- First submitted
- 5 Nov 2013
- Last updated
- 4 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexamethasone on the Duration and Functionality of Bupivacaine Intercostal Nerve Blockade
- ClinicalTrials.gov ID
- NCT02005575
- Acronym / sponsor ID
- Pro00032069
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 9 Dec 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 proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function.
Detailed description
Our study proposes two groups of 25 patients undergoing similar VATS surgery with a single surgeon, Dr. R. McKenna, who will receive interoperatively placed intercostal nerve blocks at the same levels. Each group will receive intercostals nerve blocks with one of two different solutions: group one will receive intercostal nerve blocks with only 0.46% bupivacaine (19.5 ml of 0.5% bupivacaine + .5 cc saline), group 2 will receive intercostal blocks with 0.46% bupivacaine and dexamethasone(19.5 ml of 0.5% bupivacaine + .5ml .4% dexamethasone). The patients will have pulmonary lung function objectively assessed by portable spirometry and clinical factors both preoperatively and postoperatively. Our study objective is to examine and quantify the potentially beneficial effects of intercostal nerve blockade prolongation with dexamethasone on postoperative pulmonary function and postoperative recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Placeboan intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline) |
| Group 2 | Active comparator | Drug: Bupivacaine and Dexamethasonean intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 - 80 years old of either gender, scheduled for unilateral VATS procedure with Dr. McKenna for resection of lung tumor.
Key exclusion criteria (20 listed)
- ASA IV and above
- Intolerance, allergy, or contraindication to use of any medications used in this study
- Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
- Uncontrolled hypertension (BP > 140/90)
- History of prior ipsilateral thorascopic surgery
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 |
|---|---|---|
| Bupivacaine and DexamethasoneAlso: DecadronThe standard of care is to use a regional block solution containing both decadron and bupivicaine. | Drug | Group 2 |
| Placebo | Drug | Group 1 |
Primary outcome
Post operative pain
Time frame: 72 hours post operatively
Patients will be evaluated for post operative pain using the NRS pain evaulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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 Phase 4 study testing Bupivacaine and Dexamethasone in people with Post Minimally Invasive Thorascopic Surgical Pain, run by Cedars-Sinai 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 1 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: status not confirmed, as of the sponsor's last update on 4 Feb 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Post operative pain (time frame: 72 hours post operatively). 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 4 Feb 2015.