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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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,
Show all 10Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04559347
- Acronym / sponsor ID
- 2007-48
- Conditions
- Thoracic Surgery
- Keywords
- Thoracic surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Poovendran SaththasivamUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine | Experimental | Drug: Liposomal Bupivacaine (EXPAREL®)/BupivacaineSingle Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic |
| Continuous catheter infusion ropivacaine | Active comparator | Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liposomal Bupivacaine (EXPAREL®)/BupivacaineAlso: EXPAREL®/BupivacaineSingle shot for erector spinae block | Drug | Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine |
| Ropivacaine (0.5% bolus followed by 0.2% infusion)Also: RopivacaineContinuous catheter infusion for erector spinae plane block | Drug | Continuous catheter infusion ropivacaine |
Primary outcome
Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative
Time frame: 2 days post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale 48-72 Hours Post-operative
Time frame: 3 days post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative
Time frame: 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
Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative
Time frame: 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
35 secondary outcomes
Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative
Time frame: 0-4 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative
Time frame: 4-8 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative
Time frame: 8-16 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative
Time frame: 16-24 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative
Time frame: 24-48 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative
Time frame: 48-72 hours post-operative
Total Intraoperative Opioid Consumption in Morphine Equivalent Dose
Time frame: From start of surgery to end of surgery, an average of 2-3 hours
Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative
Time frame: 0-4 hours post-operative
Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative
Time frame: 4-8 hours post-operative
Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative
Time frame: 8-16 hours post-operative
Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative
Time frame: 16-24 hours post-operative
Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative
Time frame: 24-48 hours post-operative
Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative
Time frame: 48-72 hours post-operative
Gabapentin Consumption in Milligrams 0-4 Hours Post-operative
Time frame: 0-4 hours post-operative
Gabapentin Consumption in Milligrams 4-8 Hours Post-operative
Time frame: 4-8 hours post-operative
Gabapentin Consumption in Milligrams 8-16 Hours Post-operative
Time frame: 8-16 hours post-operative
Gabapentin Consumption in Milligrams 16-24 Hours Post-operative
Time frame: 16-24 hours post-operative
Gabapentin Consumption in Milligrams 24-48 Hours Post-operative
Time frame: 24-48 hours post-operative
Gabapentin Consumption in Milligrams 48-72 Hours Post-operative
Time frame: 48-72 hours post-operative
Ketorolac Consumption in Milligrams 0-4 Hours Post-operative
Time frame: 0-4 hours post-operative
Ketorolac Consumption in Milligrams 4-8 Hours Post-operative
Time frame: 4-8 hours post-operative
Ketorolac Consumption in Milligrams 8-16 Hours Post-operative
Time frame: 8-16 hours post-operative
Ketorolac Consumption in Milligrams 16-24 Hours Post-operative
Time frame: 16-24 hours post-operative
Ketorolac Consumption in Milligrams 24-48 Hours Post-operative
Time frame: 24-48 hours post-operative.
Ketorolac Consumption in Milligrams 48-72 Hours Post-operative
Time frame: 48-72 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative
Time frame: 12-24 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative
Time frame: 24-48 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative
Time frame: 48-72 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative
Time frame: 0-4 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative
Time frame: 4-8 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative
Time frame: 8-12 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative
Time frame: 12-24 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative
Time frame: 24-48 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative
Time frame: 48-72 hours post-operative
Length of Hospital Stay
Time frame: From date of admission until date of discharge, an average of 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Poovendran Saththasivam, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative (time frame: 0-4 hours post operative). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.