Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery
Erector Spinae vs. Intercostal Nerve Blocks for Thoracic Surgery Pain
Plain English Summary
Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery is a Phase 3 clinical trial sponsored by George Washington University studying Lung Cancers. Tests two types of nerve blocks to reduce pain after thoracic surgery. For patients undergoing video-assisted pulmonary resection, pleurodesis, or decortication. Participation involves a preoperative block and an intraoperative block. No other pain management methods are used. The trial aims to enroll 120 participants.
Official Summary
This clinical trial compares efficacy in postoperative pain management in thoracic surgery between erector spinae block versus liposomal bupivacaine injections.
Who Can Participate
Here is what you need to know about eligibility for this trial. Can join if undergoing video-assisted pulmonary resection, pleurodesis, or decortication. Cannot join if allergic to local anesthetics, undergoing bilateral surgery, or if surgery is emergent. Age: Not specified, but typically adults. Health: Good overall health, as determined by the doctor. This trial is studying Lung Cancers, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well the blocks work to control pain, which helps patients manage discomfort after surgery. The specific primary outcome measures are: Postoperative pain control assessment (Up to 48 hours postoperatively); Morphine equivalent assessment (Up to 72 hours postoperatively). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to fill a gap in postoperative pain management for thoracic surgery patients. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Lung Cancers, where improved treatment options are needed.
Investor Insight
Market size is large, with competitive trials, but a high approval probability given the need for better pain management. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if you are a good candidate for this trial. You will receive two types of nerve blocks before and during surgery. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 120 participants
Interventions
- DRUG: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) — preoperative erector spinae block with bupivacaine (Marcaine®)
- DRUG: Intercostal nerve block — intraoperative intercostal nerve block with liposomal bupivacaine (Exparel®)
Primary Outcomes
- Postoperative pain control assessment (Up to 48 hours postoperatively)
- Morphine equivalent assessment (Up to 72 hours postoperatively)
Secondary Outcomes
- Postoperative pain control assessment (Up to 72 hours postoperatively)
Full Eligibility Criteria
Inclusion Criteria: * Video assisted pulmonary resection, pleurodesis or decortication Exclusion Criteria: * Allergy to local anesthetics * Patient undergoing bilateral surgery * Surgery is emergent as deemed by the principal investigator
Trial Locations
- The George Washington University Hospital, Washington D.C., District of Columbia, United States
Frequently Asked Questions
What is clinical trial NCT06810375?
NCT06810375 is a Phase 3 INTERVENTIONAL study titled "Erector Spinae Versus Intercostal Nerve Blocks With Liposomal Bupivacaine for Analgesia in Thoracic Surgery." It is currently recruiting and is sponsored by George Washington University. The trial targets enrollment of 120 participants.
What conditions does NCT06810375 study?
This trial investigates treatments for Lung Cancers. The primary condition under study is Lung Cancers.
What treatments are being tested in NCT06810375?
The interventions being studied include: Erector Spinae (ESP) Block with Bupivacaine (Marcaine®) (DRUG), Intercostal nerve block (DRUG). preoperative erector spinae block with bupivacaine (Marcaine®)
What does Phase 3 mean for NCT06810375?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT06810375?
This trial is currently "Recruiting." It started on 2025-03-01. The estimated completion date is 2029-02-28.
Who is sponsoring NCT06810375?
NCT06810375 is sponsored by George Washington University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06810375?
The trial aims to enroll 120 participants. The trial is currently recruiting and accepting new participants.
How is NCT06810375 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06810375?
The primary outcome measures are: Postoperative pain control assessment (Up to 48 hours postoperatively); Morphine equivalent assessment (Up to 72 hours postoperatively). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06810375 being conducted?
This trial is being conducted at 1 site, including Washington D.C., District of Columbia (United States).
Where can I find official information about NCT06810375?
The official record for NCT06810375 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06810375. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06810375 testing in simple terms?
Tests two types of nerve blocks to reduce pain after thoracic surgery. For patients undergoing video-assisted pulmonary resection, pleurodesis, or decortication.
Why is this trial significant?
This trial aims to fill a gap in postoperative pain management for thoracic surgery patients. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT06810375?
Possible risks include allergic reactions to the anesthetics used. Side effects may include temporary numbness or weakness in the area treated. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06810375?
Ask your doctor if you are a good candidate for this trial. You will receive two types of nerve blocks before and during surgery. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06810375 signal from an investment perspective?
Market size is large, with competitive trials, but a high approval probability given the need for better pain management. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participation involves a preoperative block and an intraoperative block. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Lung Cancers Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.