Robotic Lung SurgeryPhase 4NCT03906617
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
A Phase 4 study testing Intercostal nerve block and wound infiltration with liposomal bupivacaine and Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone in people with Robotic Lung Surgery, run by Cooper Norcross Health at 1 site in United States.
Trial summary
This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Robotic Lung Surgery
- What is being tested?
- Intercostal nerve block and wound infiltration with liposomal bupivacaine and Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2019to 10 Jun 2022
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing robotic wedge resection or lobectomy for lung mass(es)
Who cannot join
- emergency case
- history of opiate abuse
- chronic pain syndrome
- intravenous drug use
- chronic use of oral steroids
- pregnancy
Show all 12Show fewer
- imprisonment
- body weight lower than 70 kg
- liver failure
- uninsured patients
- non-verbal patients or patients who are unable to rate their pain on a visual analogue pain scale
- history of allergic reaction to any of the drugs used in the study: bupivacaine, liposomal bupivacaine, dexamethasone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cooper University Hospital
Camden, New Jersey, 08103
Noud van Helmond, MD, 856-968-7336, vanhelmond-noud@cooperhealth.edu
About this study
Official title: Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.
- Conditions
- Robotic Lung Surgery
- Being tested
- Intercostal nerve block and wound infiltration with liposomal bupivacaine, Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal nerve block and wound infiltration with liposomal bupivacaineDrug
Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 266mg of liposomal bupivacaine with 24 ml of 0.5% bupivacaine will be used.
Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasoneDrug
Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 42 ml of 0.5% Bupivacaine/epinephrine with 8mg dexamethasone will be used.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine/epinephrine + dexamethasone | Experimental | Not described Receives: Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone |
| Liposomal bupivacaine | Active comparator | Not described Receives: Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale pain scores
Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior.
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start10 Apr 2019
- Primary completion10 Apr 2022 (estimated)
- Study completion10 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Lung SurgeryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cooper Norcross Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kingsuk Ganguly, M.D., Cooper Norcross Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906617
- Sponsor's protocol ID
- 18039
- Status last verified
- Nov 2021
- First submitted
- 5 Apr 2019
- Last updated
- 12 Nov 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title of Project: Liposomal Bupivacaine (Exparel) Versus Bupivacaine And Dexamethasone Intercostal Nerve Blocks For Robotic Thoracic Surgery: A Prospective Randomized Single-Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT03906617
- Acronym / sponsor ID
- 18039
- Conditions
- Robotic Lung Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Cooper Norcross HealthUniversity, hospital or other
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 10 Apr 2022 (estimated)
- Study completion
- 10 Jun 2022 (estimated)
- First posted
- 8 Apr 2019 (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.
This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine/epinephrine + dexamethasone | Experimental | Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone |
| Liposomal bupivacaine | Active comparator | Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing robotic wedge resection or lobectomy for lung mass(es)
Key exclusion criteria (12 listed)
- emergency case
- history of opiate abuse
- chronic pain syndrome
- intravenous drug use
- chronic use of oral steroids
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 |
|---|---|---|
| Intercostal nerve block and wound infiltration with liposomal bupivacaineIntercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 266mg of liposomal bupivacaine with 24 ml of 0.5% bupivacaine will be used. | Drug | Liposomal bupivacaine |
| Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasoneIntercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 42 ml of 0.5% Bupivacaine/epinephrine with 8mg dexamethasone will be used. | Drug | Bupivacaine/epinephrine + dexamethasone |
Primary outcome
Visual Analogue Scale pain scores
Time frame: 24 hours post-surgery
Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
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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.
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 Intercostal nerve block and wound infiltration with liposomal bupivacaine and Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone in people with Robotic Lung Surgery, run by Cooper Norcross Health 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 12 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: looking for participants now, as of the sponsor's last update on 12 Nov 2021. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noud van Helmond, MD (856-968-7336, vanhelmond-noud@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale pain scores (time frame: 24 hours post-surgery). 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 12 Nov 2021.