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

• ClinicalTrials.gov Identifier: NCT04559347
• Recruitment Status: Recruiting
• First Posted: September 22, 2020
• Last Update Posted: December 17, 2020
• Sponsor: The Guthrie Clinic
• Information provided by (Responsible Party): The Guthrie Clinic

Tracking Information

• First Submitted Date: September 9, 2020
• First Posted Date: September 22, 2020
• Last Update Posted Date: December 17, 2020
• Actual Study Start Date: December 10, 2020
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 18, 2020)

Numerical Rated Pain Scale (NRP) [ Time Frame: 3 days post-operative ]

Patient reported pain scale (0-10)

Original Primary Outcome Measures (submitted: September 16, 2020)

Post-operative opioid consumption [ Time Frame: 3 days post-operative ]

Post-operative opioid consumption in morphine equivalents to determine total morphine.

Current Secondary Outcome Measures (submitted: November 18, 2020)

• Post-operative opioid consumption [ Time Frame: 3 days post-operative ]
  Post-operative opioid consumption in morphine equivalents to determine total morphine.
• Total Intraoperative narcotic [ Time Frame: At end of surgery ]
  Total opioids administered in the operating room surgery in morphine equivalents.
• Total adjunct pain medication consumption [ Time Frame: 3 days post-operative ]
  Non-narcotic pain medications such as acetaminophen, gabapentin, ketorolac, etc.
• Incentive spirometry changes from preoperative baseline to 3 days post-operative [ Time Frame: 3 days post-operative ]
  Incentive spirometry change from preoperative baseline to 3 days post-operative
• Length of hospital stay [ Time Frame: From date of admission until date of discharge, an average of 3 days ]
  Number of days from admission to discharge
• Postoperative Quality of Recovery score (QOR-15) [ Time Frame: 3 days 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.
• Adverse events frequency [ Time Frame: up to 72 hours ]
  Frequency and type of adverse events associated with Single Shot Liposomal Bupivacaine (Exparel)/Bupivacaine (SS) and Ropivacaine 0.5% BOLUS followed by Ropivacaine 0.2% continuous infusion

Original Secondary Outcome Measures (submitted: September 16, 2020)

• Total Intraoperative narcotic [ Time Frame: At end of surgery ]
  Total opioids administered in the operating room surgery in morphine equivalents.
• Total adjunct pain medication consumption [ Time Frame: 3 days post-operative ]
  Non-narcotic pain medications such as acetaminophen, gabapentin, ketorolac, etc.
• Incentive spirometry changes from preoperative baseline to 3 days post-operative [ Time Frame: 3 days post-operative ]
  Incentive spirometry change from preoperative baseline to 3 days post-operative
• Numerical Rated Pain Scale (NRP) [ Time Frame: 3 days post-operative ]
  Patient reported pain scale (0-10)
• Length of hospital stay [ Time Frame: From date of admission until date of discharge, an average of 3 days ]
  Number of days from admission to discharge
• Postoperative Quality of Recovery score (QOR-15) [ Time Frame: 3 days 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.
• Adverse events frequency [ Time Frame: up to 72 hours ]
  Frequency and type of adverse events associated with Single Shot Liposomal Bupivacaine (Exparel)/Bupivacaine (SS) and Ropivacaine 0.5% BOLUS followed by Ropivacaine 0.2% continuous infusion

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery
• 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
• Brief 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.
• 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
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment

• Condition: Thoracic Surgery

Intervention

• Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
  Single shot for erector spinae block
  Other Name: EXPAREL®/Bupivacaine
• Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)
  Continuous catheter infusion for erector spinae plane block
  Other Name: Ropivacaine

Study Arms

• Experimental: Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
  Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
  Intervention: Drug: Liposomal Bupivacaine (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
  Intervention: Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 18, 2020): 74
• Original Estimated Enrollment (submitted: September 16, 2020): 114
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Poovendran Saththasivam, MD; 570-887-4676; Poovendran.Saththasivam@guthrie.org

Contact: Nathaniel McElhaney, MD; 570-887-2300; Nathaniel.McElhaney@guthrie.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04559347
• Other Study ID Numbers: 2007-48
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: The Guthrie Clinic
• Study Sponsor: The Guthrie Clinic
• Collaborators: Not Provided

Investigators

• Principal Investigator: Poovendran Saththasivam, MD; The Guthrie Clinic

• PRS Account: The Guthrie Clinic
• Verification Date: December 2020