Thoracic SurgeryPhase 2NCT04559347
Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery
A Phase 2 study testing Liposomal Bupivacaine (EXPAREL®)/Bupivacaine and Ropivacaine (0.5% bolus followed by 0.2% infusion) in people with Thoracic Surgery, run by Poovendran Saththasivam at 1 site in United States.
Trial summary
The purpose of this research is to compare a single shot long acting local anesthetic to catheter infusion of local anesthetic in patients undergoing video assisted thoracoscopic (VAT) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Surgery
- What is being tested?
- Liposomal Bupivacaine (EXPAREL®)/Bupivacaine and Ropivacaine (0.5% bolus followed by 0.2% infusion)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2020to 7 Aug 2024
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who are age > 18, undergoing video thoracoscopic surgery and following Guthrie Robert Packer Hospital's Enhanced Recovery After Surgery (ERAS) protocol for Thoracic Surgery.
Who cannot join
- weight < 50 kg, pregnant subjects,
- left ventricular ejection fraction < 30%,
- history of drug or narcotic abuse,
- history of allergic to amide local anesthetic,
- presence of contraindication for erector spinae plane block (local skin infection, sepsis, severe coagulopathy)
- unable to provide consent,
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- unable to use pain rating scales as demonstrated by verbal feedback
- preoperative chronic pain on narcotics,
- history of renal insufficiency ( Creatinine > 1.5 mg/dl),
- preoperative mild liver impairment ( i.e. AST/ALT above 1.5 times the upper normal limit)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivicaine) Versus Continuous Erector Spinae Plane Block Catheter in Patients Undergoing Video Assisted Thoracoscopic (VAT) Surgery; Single Center, Non Inferiority, Open Label, Randomized Trial
The purpose of this research is to compare a single shot long acting local anesthetic to catheter infusion of local anesthetic in patients undergoing video assisted thoracoscopic (VAT) surgery.
Read the detailed description
The purpose of this research is to compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% bolus followed by 0.2% infusion of local anesthetic using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.
- Conditions
- Thoracic Surgery
- Being tested
- Liposomal Bupivacaine (EXPAREL®)/Bupivacaine, Ropivacaine (0.5% bolus followed by 0.2% infusion)
- Keywords
- Thoracic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine (EXPAREL®)/BupivacaineDrug
Also called EXPAREL®/Bupivacaine
Single shot for erector spinae block
Ropivacaine (0.5% bolus followed by 0.2% infusion)Drug
Also called Ropivacaine
Continuous catheter infusion for erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Experimental | Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic Receives: Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine |
| Continuous catheter infusion ropivacaine | Active comparator | Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic Receives: Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 0-4 hours post operative
Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 4-8 hours post operative
Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 8-12 hours post operative
Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 12-24 hours post operative
Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 2 days post operative
Numeric Rated Pain Scale 48-72 Hours Post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 3 days post-operative
Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 0-4 hours post-operative
Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 4-8 hours post-operative
Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 8-12 hours post-operative
Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 12-24 hours post-operative
Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 24-48 hours post-operative
Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Measured: 48-72 hours post-operative
Secondary outcomes (35)
Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Measured: 0-4 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Measured: 4-8 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Measured: 8-16 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Measured: 16-24 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Measured: 24-48 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Measured: 48-72 hours post-operative
Total Intraoperative Opioid Consumption in Morphine Equivalent Dose
Total opioids administered in morphine equivalent dose (MED) in the operating room during the surgery. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
Measured: From start of surgery to end of surgery, an average of 2-3 hours
Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Measured: 0-4 hours post-operative
Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Measured: 4-8 hours post-operative
Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Measured: 8-16 hours post-operative
Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Measured: 16-24 hours post-operative
Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Measured: 24-48 hours post-operative
Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
Measured: 48-72 hours post-operative
Gabapentin Consumption in Milligrams 0-4 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Measured: 0-4 hours post-operative
Gabapentin Consumption in Milligrams 4-8 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Measured: 4-8 hours post-operative
Gabapentin Consumption in Milligrams 8-16 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Measured: 8-16 hours post-operative
Gabapentin Consumption in Milligrams 16-24 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Measured: 16-24 hours post-operative
Gabapentin Consumption in Milligrams 24-48 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Measured: 24-48 hours post-operative
Gabapentin Consumption in Milligrams 48-72 Hours Post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
Measured: 48-72 hours post-operative
Ketorolac Consumption in Milligrams 0-4 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Measured: 0-4 hours post-operative
Ketorolac Consumption in Milligrams 4-8 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Measured: 4-8 hours post-operative
Ketorolac Consumption in Milligrams 8-16 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Measured: 8-16 hours post-operative
Ketorolac Consumption in Milligrams 16-24 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Measured: 16-24 hours post-operative
Ketorolac Consumption in Milligrams 24-48 Hours Post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
Measured: 24-48 hours post-operative.
Ketorolac Consumption in Milligrams 48-72 Hours Post-operative
Ketorolac is a pain medication that is not an opioid. The ketorolac use in milligrams will be compared in each group at different time points.
Measured: 48-72 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Measured: 12-24 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Measured: 24-48 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
Measured: 48-72 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 0 to 4 hours post-operative). A negative number reflects reduced volume of air.
Measured: 0-4 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 4 to 8 hours post-operative). A negative number reflects reduced volume of air.
Measured: 4-8 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 8 to 12 hours post-operative). A negative number reflects reduced volume of air.
Measured: 8-12 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 12 to 24 hours post-operative). A negative number reflects reduced volume of air.
Measured: 12-24 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 24 to 48 hours post-operative). A negative number reflects reduced volume of air.
Measured: 24-48 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 48 to 72 hours post-operative). A negative number reflects reduced volume of air.
Measured: 48-72 hours post-operative
Length of Hospital Stay
Number of hours from admission to discharge
Measured: From date of admission until date of discharge, an average of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start10 Dec 2020
- Primary completion10 Jan 2024
- Study completion7 Aug 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Thoracic SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% followed by 0.2% infusion using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poovendran Saththasivam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Poovendran Saththasivam, The Guthrie Clinic
- Investigators
- Poovendran Saththasivam, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559347
- Sponsor's protocol ID
- 2007-48
- Status last verified
- May 2025
- First submitted
- 9 Sep 2020
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No