Pain, PostoperativePhase 1/2NCT03560362
Postoperative Pain Control With Lipossomic Extended Release Bupivacaine
A Phase 1/2 study testing Bupivacaine liposome and Bupivacaine / Epinephrine in people with Pain, Postoperative and Lung Cancer, run by University of Tennessee at 1 site in United States.
Trial summary
Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Lung Cancer
- What is being tested?
- Bupivacaine liposome and Bupivacaine / Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2015to 31 Oct 2018
- Phase
- Phase 1/2
- 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
None listed.
Who cannot join
- Open surgery
- Chronic use of narcotics
- Use of pregabalin or similar
- Significant liver or kidney dysfunction
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Methodist University Hospital
Memphis, Tennessee, 38104
Benny Weksler, 901-448-2918, bweksler@uthsc.edu
About this study
Official title: Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery
Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.
Read the detailed description
Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.
- Conditions
- Pain, Postoperative, Lung Cancer
- Being tested
- Bupivacaine liposome, Bupivacaine / Epinephrine
- Keywords
- bupivacaine, lipossomal extended release bupivacaine, Intercostal nerve block, thoracic surgery, minimally invasive surgery
- Medical subject headings
- Pain, Postoperative, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine liposomeDrug
Bupivacaine / EpinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine with epinephrine | Active comparator | Patients will receive intraoperative intercostal nerve block with bupivacaine Receives: Drug: Bupivacaine / Epinephrine |
| Lipossomal extended release bupivacaine | Experimental | Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine Receives: Drug: Bupivacaine liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.
Measured: 3-5 days post op
Secondary outcomes (2)
Postoperative complications
Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.
Measured: 90 days post op
Narcotic used
Amount of morphine equivalent dosage used in the postoperative period
Measured: 3-5 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start9 Jul 2015
- Primary completion31 Oct 2018 (estimated)
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benny Weksler, University of Tennessee
- Investigators
- Benny Weksler, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560362
- Sponsor's protocol ID
- 15-03838
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery
- ClinicalTrials.gov ID
- NCT03560362
- Acronym / sponsor ID
- 15-03838
- Conditions
- Pain, Postoperative, Lung Cancer
- Keywords
- bupivacaine, lipossomal extended release bupivacaine, Intercostal nerve block, thoracic surgery, minimally invasive surgery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 9 Jul 2015 (actual)
- Primary completion
- 31 Oct 2018 (estimated)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 18 Jun 2018 (actual)
- 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.
Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.
Detailed description
Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine with epinephrine | Active comparator | Drug: Bupivacaine / EpinephrinePatients will receive intraoperative intercostal nerve block with bupivacaine |
| Lipossomal extended release bupivacaine | Experimental | Drug: Bupivacaine liposomePatients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- Open surgery
- Chronic use of narcotics
- Use of pregabalin or similar
- Significant liver or kidney dysfunction
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 liposome | Drug | Lipossomal extended release bupivacaine |
| Bupivacaine / Epinephrine | Drug | Bupivacaine with epinephrine |
Primary outcome
Postoperative pain
Time frame: 3-5 days post op
Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.
2 secondary outcomes
Postoperative complications
Time frame: 90 days post op
Narcotic used
Time frame: 3-5 days post op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- Individual participant dataSharing planned: No
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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.
Benny Weksler, MD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bupivacaine liposome and Bupivacaine / Epinephrine in people with Pain, Postoperative and Lung Cancer, run by University of Tennessee 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 0 inclusion and 4 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 20 Jun 2018. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Benny Weksler, MD (901-448-2918, bweksler@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 3-5 days post op). 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 Jun 2018.