Trial Outcomes & Findings for Video-assisted Thoracoscopic Surgery - Exparel Study (NCT NCT04864210)
NCT ID: NCT04864210
Last Updated: 2026-05-06
Results Overview
The number of subjects who utilized opioid medications in the first 48 hours after surgery
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
176 participants
Primary outcome timeframe
Up to 48 hours post procedure
Results posted on
2026-05-06
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
87
|
|
Overall Study
COMPLETED
|
72
|
72
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Video-assisted Thoracoscopic Surgery - Exparel Study
Baseline characteristics by cohort
| Measure |
Liposomal Bupivacaine
n=72 Participants
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.
|
Bupivacaine
n=72 Participants
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
|
Total
n=144 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.24 years
STANDARD_DEVIATION 12.11 • n=54 Participants
|
64.77 years
STANDARD_DEVIATION 10.78 • n=60 Participants
|
64.01 years
STANDARD_DEVIATION 11.46 • n=114 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=54 Participants
|
47 Participants
n=60 Participants
|
93 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=54 Participants
|
25 Participants
n=60 Participants
|
51 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
White
|
71 Participants
n=54 Participants
|
71 Participants
n=60 Participants
|
142 Participants
n=114 Participants
|
|
Race/Ethnicity, Customized
Non Hispanic Non White
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
72 participants
n=54 Participants
|
72 participants
n=60 Participants
|
144 participants
n=114 Participants
|
|
American Society of Anesthesiologists Physical Status Classification System (ASA Class)
ASA 3-4
|
40 Participants
n=54 Participants
|
44 Participants
n=60 Participants
|
84 Participants
n=114 Participants
|
|
American Society of Anesthesiologists Physical Status Classification System (ASA Class)
ASA 1-2
|
32 Participants
n=54 Participants
|
28 Participants
n=60 Participants
|
60 Participants
n=114 Participants
|
|
Incentive spirometry baseline
|
2388 ml
STANDARD_DEVIATION 846.29 • n=54 Participants
|
2034 ml
STANDARD_DEVIATION 884.94 • n=60 Participants
|
2211.00 ml
STANDARD_DEVIATION 865.83 • n=114 Participants
|
|
Pain severity baseline
|
1.27 Numerical Rating Score (0-10)
STANDARD_DEVIATION 1.92 • n=54 Participants
|
1.12 Numerical Rating Score (0-10)
STANDARD_DEVIATION 1.50 • n=60 Participants
|
1.20 Numerical Rating Score (0-10)
STANDARD_DEVIATION 1.72 • n=114 Participants
|
|
Pain interference baseline
|
1.06 units on a scale
STANDARD_DEVIATION 1.80 • n=54 Participants
|
1.05 units on a scale
STANDARD_DEVIATION 1.78 • n=60 Participants
|
1.06 units on a scale
STANDARD_DEVIATION 1.79 • n=114 Participants
|
|
Quality of Recovery-15 baseline
|
129.3 Quality Of Recovery-15 score
STANDARD_DEVIATION 26.76 • n=54 Participants
|
128.5 Quality Of Recovery-15 score
STANDARD_DEVIATION 24.09 • n=60 Participants
|
128.90 Quality Of Recovery-15 score
STANDARD_DEVIATION 25.46 • n=114 Participants
|
|
Pain Catastrophizing Scale baseline
|
5.03 units on a scale
STANDARD_DEVIATION 9.17 • n=54 Participants
|
4.46 units on a scale
STANDARD_DEVIATION 7.86 • n=60 Participants
|
4.75 units on a scale
STANDARD_DEVIATION 8.54 • n=114 Participants
|
PRIMARY outcome
Timeframe: Up to 48 hours post procedureThe number of subjects who utilized opioid medications in the first 48 hours after surgery
Outcome measures
| Measure |
Liposomal Bupivacaine
n=72 Participants
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.
|
Bupivacaine
n=72 Participants
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
|
|---|---|---|
|
Number of Subjects With Post-operative Opioid Usage
|
42 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: Up to 24 hours post procedureUsing 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.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=72 Participants
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.
|
Bupivacaine
n=72 Participants
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
|
|---|---|---|
|
Measure Lung Function
|
1016 ml
Interval 517.0 to 1916.0
|
967 ml
Interval 400.0 to 1500.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=72 Participants
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.
|
Bupivacaine
n=72 Participants
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
|
|---|---|---|
|
Measure Post-operative Opioid Consumption Following Discharge From the Hospital
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=72 Participants
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.
|
Bupivacaine
n=72 Participants
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
|
|---|---|---|
|
Post-operative Numerical Rating Scores After Discharge From the Hospital
|
0.53 Units on Numerical Rating scale
Standard Deviation 1.19
|
0.77 Units on Numerical Rating scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: Up to 24 hours post procedureUsing 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.
Outcome measures
| Measure |
Liposomal Bupivacaine
n=72 Participants
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.
|
Bupivacaine
n=72 Participants
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
|
|---|---|---|
|
Post-operative Acute Pain Numerical Rating Scores
|
6 units on numerical rating scale
Interval 3.0 to 8.0
|
7 units on numerical rating scale
Interval 5.0 to 8.0
|
Adverse Events
Liposomal Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bupivacaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place