Video-assisted Thoracoscopic Surgery - Exparel Study

Study Overview
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Brief Summary
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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 (1). 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.

Detailed Description
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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.

Official Title
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Analgesia for Video-assisted Thoracoscopic Surgeries: A Comparison Between Intercostal Blocks With Liposomal Bupivacaine and Paravertebral Blocks With Plain Bupivacaine

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Liposomal bupivacaine
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years and less than 80 years Undergoing video-assisted thoracoscopic surgery (VATS) procedure BMI less than 40 Exclusion Criteria: Unable to provide informed consent Non-English speaking Pregnant BMI greater than 40 Video-assisted thoracoscopic surgery pleurodesis subjects Patients with pre-existing chronic pain Opioid tolerance Pain syndromes including fibromyalgia, regional pain syndrome or post therapeutic neuralgia in a thoracic distribution Allergy to the study medication Patients with infectious disease Patients with impaired coagulation Severe hepatic disease Incarcerated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal bupivacaine<br>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). | Drug: Liposomal bupivacaine<br>* 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.<br>|
| Active Comparator: Bupivacaine<br>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. | Drug: Bupivacaine<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure post-operative acute pain 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 72 hours post procedure | 
| Measure post-operative opioid usage | Review the subjects medical record to determine the type and amount of opioid medication that has been taken by the subject in the first 72 hours after surgery, | Up to 72 hours post procedure | 

Secondary Outcome Measures

| Outcome Measure | 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. | Up to 72 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. | 
| Measure post-operative pain 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. | 
| Calculate length of hospital stay | Record the number of days the patients in both arms are hospitalized post VATS procedure. Compare these values between the two groups. | Up to 7 days | 
| Record the return to normal bowel function | The patient will be asked to report when normal bowel function has returned. It will provide clinicians information as to when other body functions have returned following surgery. | Up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Video-assisted thoracoscopic surgery (VATS), Paravertebral blocks, Liposomal Bupivacaine (Exparel)