Lung CancerPhase 4NCT03642457
Efficacy Between Serratus Plane Block And Local Infiltration In Vats
A Phase 4 study testing Bupivacaine and Bupivacaine liposome in people with Lung Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Bupivacaine and Bupivacaine liposome
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2018to 31 Dec 2018
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiology) class I-IV
- age 81-75
Who cannot join
- ASA class V
- morbid obesity
- patient refusal
- patients with chronic pain or on pain medications
- allergy to LA
- patients receiving any additional regional techniques
Show all 10Show fewer
- coagulopathy
- patients receiving systemic anticoagulation
- local infection
- procedures anticipated to last more than 5 hours.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mount Sinai St. Luke's Hospital
New York, New York, 10019
Mount Sinai West Hospital
New York, New York, 10019
About this study
Official title: Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial
Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.
Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.
Read more
The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.
The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.
Read the detailed description
Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.
- Conditions
- Lung Cancer
- Being tested
- Bupivacaine, Bupivacaine liposome
- Keywords
- Video assisted thoracoscopic surgery, Serratus plane block, local infiltration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
20 cc 0.5%
Bupivacaine liposomeDrug
133mg liposomal bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| Serratus Plane Group | Active comparator | Patients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. Receives: Drug: Bupivacaine; Drug: Bupivacaine liposome |
| Placebo Group | Placebo comparator | Patients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. Receives: Drug: Bupivacaine liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Opioid Consumption
The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
Measured: up to 24 hours post procedure
Secondary outcomes (5)
Time to First Dose of Narcotic Administration
Time to first dose of narcotic administration post procedure
Measured: up to 24 hours post procedure
PACU Length of Stay
The length of stay post procedure in the PACU
Measured: average 3-4 hours post procedure
ICU Length of Stay
The length of stay post procedure in the or ICU
Measured: up to 40 hours post procedure
Visual Analogue Score (VAS)
Visual Analogue Score (VAS) pain score from 0 (no pain) to 10 (most pain)
Measured: up to 24 hours post procedure
Patient Satisfaction Score
Patient satisfaction score from 0 (not satisfied) to 10 (extremely satisfied)
Measured: up to 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Why it stopped: PI left institution and unable to find new PI
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Lai, Icahn School of Medicine at Mount Sinai
- Investigators
- Yan Lai, MD, MPH, Principal investigator, cahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642457
- Sponsor's protocol ID
- GCO 17-1294
- Status last verified
- Sep 2020
- First submitted
- 20 Aug 2018
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
PubMed 27543533Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
PubMed 21831090Thoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Serratus Plane Block And Local Surgical Infiltration In Robotic Video Assisted Thoracoscopic Surgery- A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03642457
- Acronym / sponsor ID
- GCO 17-1294
- Conditions
- Lung Cancer
- Keywords
- Video assisted thoracoscopic surgery, Serratus plane block, local infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left institution and unable to find new PI
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 18 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic video-assisted thoracoscopic surgery (VATS) is increasingly being used as it is a less invasive surgery compared to traditional methods, but the acute pain at an early stage after VATS has a major impact on perioperative outcomes. Effective post operative analgesia is believed to reduce morbidity, quicken recovery, improve patient outcome and reduce hospital costs. The site and extent of the incision influences the degree of pain due to disruption of intercostal nerves as well as inflammation of chest wall and pleura. Neuraxial and systemic opioids have been a gold standard as a part of multimodal analgesia for thoracic surgeries. Numerous modalities have been studied: thoracic paravertebral nerve blocks, thoracic epidural analgesia, intercostal nerve blocks, patient controlled analgesia (PCA), cryo-analgesia, transcutaneous electrical nerve stimulation (TENS), inter-pleural blocks, stellate ganglion blocks, long thoracic nerve blocks, and infiltration under direct vision by the surgeon.
Serratus plane block is an emerging regional technique that has proven to be effective in comparison to paravertebral blocks in patients undergoing breast surgery and mastectomy with reduced perioperative opioid consumption and improved pain scores.
The lateral pectoral nerve, medial pectoral nerve, intercostal nerves and long thoracic nerve are all targets for the serratus plane block. It can be safely performed under ultrasound guidance.
The purpose of the study is to evaluate the difference in quality of analgesia between efficacy of serratus plane block and local surgical infiltration by surgeon as measured by patient opioid consumption and pain scores.
Detailed description
Participants will be assigned randomly using a computer-generated table of numbers to either serratus group or infiltration group. Block team will perform all blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Serratus Plane Group | Active comparator | Drug: Bupivacaine, Drug: Bupivacaine liposomePatients randomized to the group will receive a total 20cc of solution consisting of 0.5% bupivacaine with 133mg of liposomal bupivacaine injected in the serratus plane with the help of an ultrasound. |
| Placebo Group | Placebo comparator | Drug: Bupivacaine liposomePatients randomized to the group will receive a total 20cc of 133mg liposomal bupivacaine injected prior to skin closure at the incision site as per surgeon's practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA (American Society of Anesthesiology) class I-IV
- age 81-75
Key exclusion criteria (10 listed)
- ASA class V
- morbid obesity
- patient refusal
- patients with chronic pain or on pain medications
- allergy to LA
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 |
|---|---|---|
| Bupivacaine20 cc 0.5% | Drug | Serratus Plane Group |
| Bupivacaine liposome133mg liposomal bupivacaine | Drug | Placebo Group, Serratus Plane Group |
Primary outcome
Amount of Opioid Consumption
Time frame: up to 24 hours post procedure
The amount of opioid consumption (in mg IV morphine equivalents) postoperatively up to 24 hours after the procedure.
5 secondary outcomes
Time to First Dose of Narcotic Administration
Time frame: up to 24 hours post procedure
PACU Length of Stay
Time frame: average 3-4 hours post procedure
ICU Length of Stay
Time frame: up to 40 hours post procedure
Visual Analogue Score (VAS)
Time frame: up to 24 hours post procedure
Patient Satisfaction Score
Time frame: up to 24 hours post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27543533Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223.
- Background: PubMed 21831090Blanco R. The 'pecs block': a novel technique for providing analgesia after breast surgery. Anaesthesia. 2011 Sep;66(9):847-8. doi: 10.1111/j.1365-2044.2011.06838.x. No abstract available.
- BackgroundThoracic paravertebral block versus pectoral nerve block for analgesia after breast surgery. Egypt J Anaesth. 2013; 30: 129-135. Wahba, SS and Kamal, SM.
- Individual participant dataSharing planned: No
Related trials for Lung Cancer
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
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.
Yan Lai, MD, MPH principal investigator
cahn School of Medicine at Mount Sinai
2 sites 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 Bupivacaine liposome in people with Lung Cancer, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 10 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 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 18 Aug 2020). 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?
Amount of Opioid Consumption (time frame: up to 24 hours post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03642457, which also lists 3 linked publications.
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 30 Sep 2020.