Thoracic DiseasesPhase 3NCT03508830
Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial
A Phase 3 study testing Liposomal bupivacaine and Bupivacaine Injection in people with Thoracic Diseases and Postoperative Pain, run by University of California, San Francisco at 1 site in United States.
Trial summary
The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thoracic Diseases, Postoperative Pain, Opioid Use
- What is being tested?
- Liposomal bupivacaine and Bupivacaine Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2018to 30 Jan 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Robotic or Video-Assisted Lung Resection for All Indications
Who cannot join
- Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
- Extra-Thoracic Procedures
- Hypersensitivity to Amide Local Analgesia
- Cardiac Conduction Abnormalities
- Hepatic Dysfunction
- Preoperative Neuropathic Pain and/or Preoperative Daily Opioid Usage
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine
The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.
- Conditions
- Thoracic Diseases, Postoperative Pain, Opioid Use
- Being tested
- Liposomal bupivacaine, Bupivacaine Injection
- Keywords
- Liposomal Bupivacaine, Intercostal Nerve Block, Minimally Invasive Thoracic Surgery
- Medical subject headings
- Thoracic Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
Bupivacaine InjectionDrug
5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Experimental | 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
Drug Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc. Receives: Drug: Liposomal bupivacaine |
| Standard Bupivacaine | Active comparator | 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
Drug Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc. Receives: Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily In-Hospital Use of Opioids
Measured in Oral Morphine Equivalents per Day
Measured: Average over Entire Length of Hospitalization (Up to 1 Week)
Secondary outcomes (3)
Average Daily In-Hospital Pain Score
Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain).
Measured: Average over Length of Hospitalization - Up to 1 Week
Number of Participants With Postoperative Pneumonia
Pneumonia (Y/N)
Measured: Index Hospitalization following Surgery until Discharge - Up to 1 Week
Length of Stay
Measured in Days
Measured: Index Hospitalization following Surgery until Discharge - Up to 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start30 Dec 2018
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes R. Kratz, MD, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508830
- Sponsor's protocol ID
- P0530291
- Status last verified
- May 2021
- First submitted
- 23 Mar 2018
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial - Liposomal Bupivacaine Versus Standard Bupivacaine
- ClinicalTrials.gov ID
- NCT03508830
- Acronym / sponsor ID
- P0530291
- Conditions
- Thoracic Diseases, Postoperative Pain, Opioid Use
- Keywords
- Liposomal Bupivacaine, Intercostal Nerve Block, Minimally Invasive Thoracic Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 30 Dec 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Experimental | Drug: Liposomal bupivacaine5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. Drug Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc. |
| Standard Bupivacaine | Active comparator | Drug: Bupivacaine Injection5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. Drug Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Robotic or Video-Assisted Lung Resection for All Indications
Key exclusion criteria (6 listed)
- Additional Thoracic Procedures (beyond lung resection and mediastinal lymphadenectomy)
- Extra-Thoracic Procedures
- Hypersensitivity to Amide Local Analgesia
- Cardiac Conduction Abnormalities
- Hepatic 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 |
|---|---|---|
| Liposomal bupivacaine5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. | Drug | Liposomal Bupivacaine |
| Bupivacaine Injection5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. | Drug | Standard Bupivacaine |
Primary outcome
Average Daily In-Hospital Use of Opioids
Time frame: Average over Entire Length of Hospitalization (Up to 1 Week)
Measured in Oral Morphine Equivalents per Day
3 secondary outcomes
Average Daily In-Hospital Pain Score
Time frame: Average over Length of Hospitalization - Up to 1 Week
Number of Participants With Postoperative Pneumonia
Time frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week
Length of Stay
Time frame: Index Hospitalization following Surgery until Discharge - Up to 1 Week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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 3 study testing Liposomal bupivacaine and Bupivacaine Injection in people with Thoracic Diseases and Postoperative Pain, run by University of California, San Francisco 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 6 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: finished, as of the sponsor's last update on 8 Jun 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Daily In-Hospital Use of Opioids (time frame: Average over Entire Length of Hospitalization (Up to 1 Week)). 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 8 Jun 2021.