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

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

Tracking Information
First Submitted Date  ICMJE September 9, 2020
First Posted Date  ICMJE September 22, 2020
Last Update Posted Date December 17, 2020
Actual Study Start Date  ICMJE December 10, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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  ICMJE Thoracic Surgery
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 18, 2020)
74
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2020)
114
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04559347
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party The Guthrie Clinic
Study Sponsor  ICMJE The Guthrie Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Poovendran Saththasivam, MD The Guthrie Clinic
PRS Account The Guthrie Clinic
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP