Pain, Postoperative
Conditions
Keywords
Video-assisted thoracoscopic surgery (VATS), Paravertebral blocks, Liposomal Bupivacaine (Exparel)
Brief summary
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.
Detailed description
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.
Interventions
DRUGLiposomal 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.
DRUGBupivacaine
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
Sponsors
Nada Sadek
American Society of Regional Anesthesia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Post-operative Opioid Usage | Up to 48 hours post procedure | The number of subjects who utilized opioid medications in the first 48 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Lung Function | Up to 24 hours post procedure | 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. |
| Measure Post-operative Opioid Consumption Following Discharge From the Hospital | Up to 6 months post procedure. | Patients will be asked to keep a pain medication diary to record their use of opioid and non-opioid medications for pain control. |
| Post-operative Numerical Rating Scores After Discharge From the Hospital | Up to 6 months post procedure. | 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. |
| Post-operative Acute Pain Numerical Rating Scores | Up to 24 hours post procedure | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNada Sadek, MD
University of Iowa
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.01 years STANDARD_DEVIATION 11.46 |
| American Society of Anesthesiologists Physical Status Classification System (ASA Class) ASA 1-2 | 60 Participants |
| American Society of Anesthesiologists Physical Status Classification System (ASA Class) ASA 3-4 | 40 Participants |
| Incentive spirometry baseline | 2388 ml STANDARD_DEVIATION 846.29 |
| Pain Catastrophizing Scale baseline | 4.46 units on a scale STANDARD_DEVIATION 7.86 |
| Pain interference baseline | 1.06 units on a scale STANDARD_DEVIATION 1.79 |
| Pain severity baseline | 1.20 Numerical Rating Score (0-10) STANDARD_DEVIATION 1.72 |
| Quality of Recovery-15 baseline | 128.5 Quality Of Recovery-15 score STANDARD_DEVIATION 24.09 |
| Race/Ethnicity, Customized Hispanic | 0 Participants |
| Race/Ethnicity, Customized Non Hispanic Non White | 0 Participants |
| Race/Ethnicity, Customized White | 71 Participants |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 93 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 0 / 72 | 0 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
None listed