Study Summary
This trial is looking for the best way to manage pain after VATS surgery, which is a minimally-invasive surgery for lung conditions.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 5 Secondary · Reporting Duration: Up to 6 months post procedure.
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Bupivacaine
1 of 2
Liposomal bupivacaine
1 of 2
Active Control
Experimental Treatment
128 Total Participants · 2 Treatment Groups
Primary Treatment: Liposomal bupivacaine · No Placebo Group · Phase 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 80 · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Khalil, Kamal G., Mina L. Boutrous, Adel D. Irani, Charles C. Miller III, Timothy R. Pawelek, Anthony L. Estrera, and Hazim J. Safi. 2015. “Operative Intercostal Nerve Blocks with Long-acting Bupivacaine Liposome for Pain Control After Thoracotomy”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2015.08.017.
- Steinthorsdottir, Kristin Julia, Lorna Wildgaard, Henrik Jessen Hansen, René Horsleben Petersen, and Kim Wildgaard. 2013. “Regional Analgesia for Video-assisted Thoracic Surgery: A Systematic Review”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezt525.
- Shariat, Ali, and Himani Bhatt. 2018. “Successful Use of Serratus Plane Block as Primary Anesthetic for Video-assisted Thoracoscopic Surgery (vats)–assisted Pleural Effusion Drainage”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2017.10.038.
- Parascandola, Salvatore A., Jessica Ibañez, Graham Keir, Jacqueline Anderson, Michael Plankey, Deanna Flynn, Candice Cody, Lorenzo De Marchi, Marc Margolis, and M. Blair Marshall. 2017. “Liposomal Bupivacaine Versus Bupivacaine/epinephrine After Video-assisted Thoracoscopic Wedge Resection†”. Interactive Cardiovascular and Thoracic Surgery. Oxford University Press (OUP). doi:10.1093/icvts/ivx044.
- Bayman, Emine Ozgur, Kalpaj R Parekh, John Keech, Nyle Larson, Mark Vander Weg, and Timothy J Brennan. 2018. “Preoperative Patient Expectations of Postoperative Pain Are Associated with Moderate to Severe Acute Pain After VATS”. Pain Medicine. Oxford University Press (OUP). doi:10.1093/pm/pny096.
- Bayman, Emine Ozgur, Kalpaj R. Parekh, John Keech, Atakan Selte, and Timothy J. Brennan. 2017. “A Prospective Study of Chronic Pain After Thoracic Surgery”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000001576.
- FURRER, M, R RECHSTEINER, V EIGENMANN, C SIGNER, U ALTHAUS, and H RIS. 1997. “Thoracotomy and Thoracoscopy: Postoperative Pulmonary Function, Pain and Chest Wall Complaints”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1016/s1010-7940(97)00105-x.
- Steegers, Monique A.H., Daphne M. Snik, Ad F. Verhagen, Miep A. van der Drift, and Oliver H.G. Wilder-Smith. 2008. “Only Half of the Chronic Pain After Thoracic Surgery Shows a Neuropathic Component”. The Journal of Pain. Elsevier BV. doi:10.1016/j.jpain.2008.05.009.
- Rice, David C., Juan P. Cata, Gabriel E. Mena, Andrea Rodriguez-Restrepo, Arlene M. Correa, and Reza J. Mehran. 2015. “Posterior Intercostal Nerve Block with Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2015.02.074.
- Thiruvenkatarajan, Venkatesan, SanjibDas Adhikary, Ashlee Pruett, and Mauricio Forero. 2018. “Erector Spinae Plane Block as an Alternative to Epidural Analgesia for Post-operative Analgesia Following Video-assisted Thoracoscopic Surgery: A Case Study and a Literature Review on the Spread of Local Anaesthetic in the Erector Spinae Plane”. Indian Journal of Anaesthesia. Medknow. doi:10.4103/ija.ija_693_17.
- Steinthorsdottir, Kristin Julia, Lorna Wildgaard, Henrik Jessen Hansen, René Horsleben Petersen, and Kim Wildgaard. 2013. “Regional Analgesia for Video-assisted Thoracic Surgery: A Systematic Review”. European Journal of Cardio-thoracic Surgery. Oxford University Press (OUP). doi:10.1093/ejcts/ezt525.
- Rice, David C., Juan P. Cata, Gabriel E. Mena, Andrea Rodriguez-Restrepo, Arlene M. Correa, and Reza J. Mehran. 2015. “Posterior Intercostal Nerve Block with Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2015.02.074.
- Khalil, Kamal G., Mina L. Boutrous, Adel D. Irani, Charles C. Miller III, Timothy R. Pawelek, Anthony L. Estrera, and Hazim J. Safi. 2015. “Operative Intercostal Nerve Blocks with Long-acting Bupivacaine Liposome for Pain Control After Thoracotomy”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2015.08.017.
- Thiruvenkatarajan, Venkatesan, SanjibDas Adhikary, Ashlee Pruett, and Mauricio Forero. 2018. “Erector Spinae Plane Block as an Alternative to Epidural Analgesia for Post-operative Analgesia Following Video-assisted Thoracoscopic Surgery: A Case Study and a Literature Review on the Spread of Local Anaesthetic in the Erector Spinae Plane”. Indian Journal of Anaesthesia. Medknow. doi:10.4103/ija.ija_693_17.
- Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27.
- Furrer M, Rechsteiner R, Eigenmann V, Signer C, Althaus U, Ris HB. Thoracotomy and thoracoscopy: postoperative pulmonary function, pain and chest wall complaints. Eur J Cardiothorac Surg. 1997 Jul;12(1):82-7. doi: 10.1016/s1010-7940(97)00105-x.
- Parascandola SA, Ibanez J, Keir G, Anderson J, Plankey M, Flynn D, Cody C, De Marchi L, Margolis M, Blair Marshall M. Liposomal bupivacaine versus bupivacaine/epinephrine after video-assisted thoracoscopic wedge resectiondagger. Interact Cardiovasc Thorac Surg. 2017 Jun 1;24(6):925-930. doi: 10.1093/icvts/ivx044.
- Shariat A, Bhatt H. Successful Use of Serratus Plane Block as Primary Anesthetic for Video-Assisted Thoracoscopic Surgery (VATS)-Assisted Pleural Effusion Drainage. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):e31-e32. doi: 10.1053/j.jvca.2017.10.038. Epub 2017 Oct 31. No abstract available.
- Rakesh Sondekoppam Vijayashankar 2021. "Video-assisted Thoracoscopic Surgery - Exparel Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04864210.
Frequently Asked Questions
Is the current research project open to enrollment of individuals over 55 years old?
"The participant requirements for this trial necessitate that patients must be over 18 yet under 80 years of age." - Anonymous Online Contributor
How many participants are currently participating in this clinical trial?
"Affirmative, according to clinicaltrials.gov this medical study is currently recruiting participants. It was initially posted on February 2nd 2021 and recently updated on September 19th 2022, with a total of 128 patients being sought from one single site." - Anonymous Online Contributor
What aims is this medical experiment hoping to achieve?
"The primary outcome of this research is to assess post-operative acute pain scores up to 72 hours after the procedure. Secondary objectives include measuring lung function using an incentive spirometer device, tracking opioid consumption following hospital discharge, and determining total length of hospital stay. The air volume inhaled will be graded on a scale from 0 - 2500 milliliters with higher values indicating greater respiratory function compared to baseline measurements before surgery." - Anonymous Online Contributor
To what extent am I eligible to join in this research experiment?
"This clinical trial is seeking 128 individuals with postoperative pain aged between 18 and 80. Notably, prospective participants must be over the age of consent, possess a body mass index below 40, and undergo video-assisted thoracoscopic surgery (VATS)." - Anonymous Online Contributor
Have any other studies been conducted involving Liposomal bupivacaine?
"Currently, 108 studies are evaluating the efficacy of Liposomal bupivacaine. 18 trials have reached Phase 3 status and they are being conducted in 143 locations primarily based around Philadelphia, Pennsylvania." - Anonymous Online Contributor
Has the Federal Drug Administration given their stamp of approval to Liposomal bupivacaine?
"Liposomal bupivacaine is rated a 2 on the safety scale, as clinical data supports its safety but there is no evidence of efficacy yet." - Anonymous Online Contributor
Are there any available vacancies for potential participants in this experiment?
"That is correct. According to clinicaltrials.gov, this medical trial has been recruiting patients since February 2nd 2021 and the listing was recently updated on September 19th 2022. 128 participants are being sought from a single site for this experiment." - Anonymous Online Contributor
For what conditions has Liposomal bupivacaine been prescribed?
"Liposomal bupivacaine is a commonly-prescribed treatment for permphigus, as well as acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell." - Anonymous Online Contributor