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| Name | Class |
|---|---|
| American Society of Regional Anesthesia | OTHER |
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Video-assisted thoracoscopic surgery (VATS) greatly decreased the number and types of surgery that required open thoracotomy. Initially it was thought that VATS would lead to a reduction of respiratory problems and less acute pain in patients when compared to patients receiving an open thoracic surgery. However, for reasons not clearly understood, a large number of patients who undergo VATS still experience moderate to severe post-surgical pain. Physicians are still faced with the challenge of providing care that will manage both the respiratory issues as well as manage acute pain. The goal of this study is to find the most suitable regimen to effectively manage post-VATS-related pain.
The "promise" was that video-assisted thoracoscopic surgery (VATS) would be associated with less severe pulmonary impairment and less acute post-operative pain compared to open thoracotomy. However, VATS can cause moderate to severe post-operative pain in a significant number of patients and the reason for this is not well understood. In addition it has been found that post-surgical pain can be a strong predictor for the development of chronic pain. Inadequate control of acute pain not only causes serious discomfort and significant respiratory problems, but it may place this population of patients at greater risk of chronic pain and prescription opioid dependence.
Current protocols to manage and/or reduce VATS associated pain include combining the use of regional anesthesia techniques with opioid and non-opioid analgesics. Recent studies have investigated the efficacy of intercostal blocks using liposomal bupivacaine after thoracic surgery. However, these studies lacked an active comparator population of patients.
The study is designed as a prospective randomized study evaluating intercostal blocks using liposomal bupivacaine. The control population of patients will be treated with a paravertebral block using plain bupivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine | Experimental | The patient will receive an intercostal nerve block by the surgeon in the operating room after anesthetic has been administered. The surgeon will use thoracoscopic guidance to administer the intercostal nerve block. The medication used in this block will liposomal bupivacaine (Exparel). |
|
| Bupivacaine | Active Comparator | The patient will receive a paravertebral block by the anesthesiologist staffing the pain service area within the hospital prior to surgery. This regional anesthesia will be done using ultrasound guidance. The medication used in this block will be plain bupivacaine with epinephrine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Surgeons will perform an intercostal nerve block in the operating room under thoracoscopic guidance while the patient is asleep under anesthesia. This intervention (block) is one of the standards of care but the medication (liposomal bupivacaine) currently is not FDA approved for this type of block. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Post-operative Opioid Usage | The number of subjects who utilized opioid medications in the first 48 hours after surgery | Up to 48 hours post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Lung Function | Using an incentive spirometer device, the amount of air volume inhaled and exhaled by the lungs post VATS procedure. The subject will be asked to do 3 attempts in succession and the number recorded will be the average of the 3 attempts. The air volume inhaled is measured on a scale from near 0 to 2500 milliliters with the low number indicating little air movement whereas 2500 milliliters indicates good air flow. These results will be compared to the volume determined at baseline prior to surgery. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nada Sadek, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29878248 | Background | Bayman EO, Parekh KR, Keech J, Larson N, Vander Weg M, Brennan TJ. Preoperative Patient Expectations of Postoperative Pain Are Associated with Moderate to Severe Acute Pain After VATS. Pain Med. 2019 Mar 1;20(3):543-554. doi: 10.1093/pm/pny096. | |
| 28248713 | Background | Bayman EO, Parekh KR, Keech J, Selte A, Brennan TJ. A Prospective Study of Chronic Pain after Thoracic Surgery. Anesthesiology. 2017 May;126(5):938-951. doi: 10.1097/ALN.0000000000001576. |
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All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | The patient will receive an intercostal nerve block by the surgeon in the operating room after anesthetic has been administered. The surgeon will use thoracoscopic guidance to administer the intercostal nerve block. The medication used in this block will liposomal bupivacaine (Exparel). Liposomal bupivacaine: Surgeons will perform an intercostal nerve block in the operating room under thoracoscopic guidance while the patient is asleep under anesthesia. This intervention (block) is one of the standards of care but the medication (liposomal bupivacaine) currently is not FDA approved for this type of block. |
| FG001 | Bupivacaine | The patient will receive a paravertebral block by the anesthesiologist staffing the pain service area within the hospital prior to surgery. This regional anesthesia will be done using ultrasound guidance. The medication used in this block will be plain bupivacaine with epinephrine. Bupivacaine: An anesthesiologist trained in regional anesthesia will perform a paravertebral block in the hospital's pain service unit. This intervention is standard of care and will use plain bupivacaine with epinephrine as the medication |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | The patient will receive an intercostal nerve block by the surgeon in the operating room after anesthetic has been administered. The surgeon will use thoracoscopic guidance to administer the intercostal nerve block. The medication used in this block will liposomal bupivacaine (Exparel). Liposomal bupivacaine: Surgeons will perform an intercostal nerve block in the operating room under thoracoscopic guidance while the patient is asleep under anesthesia. This intervention (block) is one of the standards of care but the medication (liposomal bupivacaine) currently is not FDA approved for this type of block. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Post-operative Opioid Usage | The number of subjects who utilized opioid medications in the first 48 hours after surgery | Posted | Count of Participants | Participants | Up to 48 hours post procedure |
|
We monitored patients for any adverse events for the duration of 6 months after the patients received the study intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Liposomal Bupivacaine | The patient will receive an intercostal nerve block by the surgeon in the operating room after anesthetic has been administered. The surgeon will use thoracoscopic guidance to administer the intercostal nerve block. The medication used in this block will liposomal bupivacaine (Exparel). Liposomal bupivacaine: Surgeons will perform an intercostal nerve block in the operating room under thoracoscopic guidance while the patient is asleep under anesthesia. This intervention (block) is one of the standards of care but the medication (liposomal bupivacaine) currently is not FDA approved for this type of block. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nada Sadek | University of Iowa Health Care | 3193562108 | nada-sadek@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 7, 2025 | Jan 31, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 7, 2025 | Jan 31, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Bupivacaine | Drug | An anesthesiologist trained in regional anesthesia will perform a paravertebral block in the hospital's pain service unit. This intervention is standard of care and will use plain bupivacaine with epinephrine as the medication |
|
| Up to 24 hours post procedure |
| Measure Post-operative Opioid Consumption Following Discharge From the Hospital | Patients will be asked to keep a pain medication diary to record their use of opioid and non-opioid medications for pain control. | Up to 6 months post procedure. |
| Post-operative Numerical Rating Scores After Discharge From the Hospital | Using a numerical rating scale, patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain. The goal for measuring after acute hospitalization is to determine if the patient is experiencing the onset of chronic pain. | Up to 6 months post procedure. |
| Post-operative Acute Pain Numerical Rating Scores | Using a numerical rating scale (0-10), patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain. | Up to 24 hours post procedure |
| 9262085 | Background | 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. |
| 18632308 | Background | Steegers MA, Snik DM, Verhagen AF, van der Drift MA, Wilder-Smith OH. Only half of the chronic pain after thoracic surgery shows a neuropathic component. J Pain. 2008 Oct;9(10):955-61. doi: 10.1016/j.jpain.2008.05.009. Epub 2008 Jul 16. |
| 24288340 | Background | 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. |
| 29416155 | Background | Adhikary SD, Pruett A, Forero M, Thiruvenkatarajan V. 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 J Anaesth. 2018 Jan;62(1):75-78. doi: 10.4103/ija.IJA_693_17. |
| 29199049 | Background | 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. |
| 26507422 | Background | Khalil KG, Boutrous ML, Irani AD, Miller CC 3rd, Pawelek TR, Estrera AL, Safi HJ. Operative Intercostal Nerve Blocks With Long-Acting Bupivacaine Liposome for Pain Control After Thoracotomy. Ann Thorac Surg. 2015 Dec;100(6):2013-8. doi: 10.1016/j.athoracsur.2015.08.017. Epub 2015 Oct 24. |
| 28329326 | Background | 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. |
| 25912739 | Background | Rice DC, Cata JP, Mena GE, Rodriguez-Restrepo A, Correa AM, Mehran RJ. Posterior Intercostal Nerve Block With Liposomal Bupivacaine: An Alternative to Thoracic Epidural Analgesia. Ann Thorac Surg. 2015 Jun;99(6):1953-60. doi: 10.1016/j.athoracsur.2015.02.074. Epub 2015 Apr 23. |
| BG001 | Bupivacaine | The patient will receive a paravertebral block by the anesthesiologist staffing the pain service area within the hospital prior to surgery. This regional anesthesia will be done using ultrasound guidance. The medication used in this block will be plain bupivacaine with epinephrine. Bupivacaine: An anesthesiologist trained in regional anesthesia will perform a paravertebral block in the hospital's pain service unit. This intervention is standard of care and will use plain bupivacaine with epinephrine as the medication |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| American Society of Anesthesiologists Physical Status Classification System (ASA Class) | The American Society of Anesthesiologists (ASA) Physical Status Classification System is a six-level, 1-6 scale (plus 'E' for emergency) used to assess and communicate a patient's pre-anesthesia medical comorbidities and predict perioperative risk. Ranging from healthy (I) to brain-dead (VI), it helps guide care, with higher scores indicating higher risk. | Count of Participants | Participants |
|
| Incentive spirometry baseline | Mean | Standard Deviation | ml |
|
| Pain severity baseline | Measured on a Numerical Rating Scale (NRS) where 0 is no pain and 10 is the worst pain | Mean | Standard Deviation | Numerical Rating Score (0-10) |
|
| Pain interference baseline | We used the Brief Pain Inventory (BPI) to measure pain interference. BPI is a widely used, self-report questionnaire that measures the intensity of pain and its interference with daily functioning. It assesses pain over the last 24 hours, including location, severity, and treatment effectiveness. Scale is 0 - 10; 0 does not interfere and 10 completely interferes. | Mean | Standard Deviation | units on a scale |
|
| Quality of Recovery-15 baseline | Quality of Recovery-15 (QoR-15) score is a patient-reported questionnaire used to evaluate the quality of recovery after surgery and anesthesia, with a total score ranging from 0 to 150. Higher scores indicate better recovery, with 135-150 representing excellent, 122-135 good, 90-121 moderate, and below 90 poor recovery https://pubmed-ncbi-nlm-nih-gov.laneproxy.stanford.edu/35430086/ | Mean | Standard Deviation | Quality Of Recovery-15 score |
|
| Pain Catastrophizing Scale baseline | The Pain Catastrophizing Scale (PCS) is a 13-item self-report questionnaire assessing how individuals perceive, feel, and think about their pain, specifically focusing on rumination, magnification, and helplessness. It is used to predict pain-related outcomes, with a total score ranging from 0 to 52, where higher scores indicate greater, more severe catastrophic thinking. | Mean | Standard Deviation | units on a scale |
|
| OG001 |
| Bupivacaine |
The patient will receive a paravertebral block by the anesthesiologist staffing the pain service area within the hospital prior to surgery. This regional anesthesia will be done using ultrasound guidance. The medication used in this block will be plain bupivacaine with epinephrine. Bupivacaine: An anesthesiologist trained in regional anesthesia will perform a paravertebral block in the hospital's pain service unit. This intervention is standard of care and will use plain bupivacaine with epinephrine as the medication |
|
|
| Secondary | Measure Lung Function | Using an incentive spirometer device, the amount of air volume inhaled and exhaled by the lungs post VATS procedure. The subject will be asked to do 3 attempts in succession and the number recorded will be the average of the 3 attempts. The air volume inhaled is measured on a scale from near 0 to 2500 milliliters with the low number indicating little air movement whereas 2500 milliliters indicates good air flow. These results will be compared to the volume determined at baseline prior to surgery. | Posted | Median | Inter-Quartile Range | ml | Up to 24 hours post procedure |
|
|
|
| Secondary | Measure Post-operative Opioid Consumption Following Discharge From the Hospital | Patients will be asked to keep a pain medication diary to record their use of opioid and non-opioid medications for pain control. | Posted | Count of Participants | Participants | Up to 6 months post procedure. |
|
|
|
| Secondary | Post-operative Numerical Rating Scores After Discharge From the Hospital | Using a numerical rating scale, patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain. The goal for measuring after acute hospitalization is to determine if the patient is experiencing the onset of chronic pain. | Posted | Mean | Standard Deviation | Units on Numerical Rating scale | Up to 6 months post procedure. |
|
|
|
| Secondary | Post-operative Acute Pain Numerical Rating Scores | Using a numerical rating scale (0-10), patients will be asked to report their pain level. The scale is from 0 to 10 with 0 being no pain and 10 representing the most intense pain. | Posted | Median | Inter-Quartile Range | units on numerical rating scale | Up to 24 hours post procedure |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Bupivacaine | The patient will receive a paravertebral block by the anesthesiologist staffing the pain service area within the hospital prior to surgery. This regional anesthesia will be done using ultrasound guidance. The medication used in this block will be plain bupivacaine with epinephrine. Bupivacaine: An anesthesiologist trained in regional anesthesia will perform a paravertebral block in the hospital's pain service unit. This intervention is standard of care and will use plain bupivacaine with epinephrine as the medication | 0 | 72 | 0 | 72 | 0 | 72 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |