Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery

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.

Study Overview

• Status: Terminated
• Conditions: Thoracic Surgery
• Intervention / Treatment: Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine; Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Sayre, Pennsylvania, United States, 18840
      • Robert Packer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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,
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine; Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic	Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine; Single shot for erector spinae block; Other Names: EXPAREL®/Bupivacaine
Active Comparator: Continuous catheter infusion ropivacaine; Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic	Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion); Continuous catheter infusion for erector spinae plane block; Other Names: Ropivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	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	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	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	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	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	48-72 hours post-operative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	48-72 hours post-operative
Length of Hospital Stay	Number of hours from admission to discharge	From date of admission until date of discharge, an average of 72 hours

Collaborators and Investigators

• Sponsor: Poovendran Saththasivam
• Investigators: Principal Investigator: Poovendran Saththasivam, MD, The Guthrie Clinic

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2020
• Primary Completion (Actual): January 10, 2024
• Study Completion (Actual): August 7, 2024

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 22, 2020

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Thoracic surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine; Bupivacaine
• Other Study ID Numbers: 2007-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No