Clinical trial NCT04559347: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Thoracic Surgery
Keywords: Thoracic surgery
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
timeFrame: 0-4 hours post operative
measure: Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative
timeFrame: 4-8 hours post operative
measure: Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative
timeFrame: 8-12 hours post operative
measure: Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative
timeFrame: 12-24 hours post operative
measure: Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative
timeFrame: 2 days post operative
measure: Numeric Rated Pain Scale 48-72 Hours Post-operative
timeFrame: 3 days post-operative
measure: Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative
timeFrame: 0-4 hours post-operative
measure: Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative
timeFrame: 4-8 hours post-operative
measure: Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative
timeFrame: 8-12 hours post-operative
measure: Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative
timeFrame: 12-24 hours post-operative
measure: Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative
timeFrame: 24-48 hours post-operative
measure: Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative
timeFrame: 48-72 hours post-operative
Secondary outcomes:
measure: Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative
timeFrame: 0-4 hours post-operative
measure: Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative
timeFrame: 4-8 hours post-operative
measure: Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative
timeFrame: 8-16 hours post-operative
measure: Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative
timeFrame: 16-24 hours post-operative
measure: Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative
timeFrame: 24-48 hours post-operative
measure: Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative
timeFrame: 48-72 hours post-operative
measure: Total Intraoperative Opioid Consumption in Morphine Equivalent Dose
timeFrame: From start of surgery to end of surgery, an average of 2-3 hours
measure: Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative
timeFrame: 0-4 hours post-operative
measure: Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative
timeFrame: 4-8 hours post-operative
measure: Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative
timeFrame: 8-16 hours post-operative
measure: Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative
timeFrame: 16-24 hours post-operative
measure: Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative
timeFrame: 24-48 hours post-operative
measure: Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative
timeFrame: 48-72 hours post-operative
measure: Gabapentin Consumption in Milligrams 0-4 Hours Post-operative
timeFrame: 0-4 hours post-operative
measure: Gabapentin Consumption in Milligrams 4-8 Hours Post-operative
timeFrame: 4-8 hours post-operative
measure: Gabapentin Consumption in Milligrams 8-16 Hours Post-operative
timeFrame: 8-16 hours post-operative
measure: Gabapentin Consumption in Milligrams 16-24 Hours Post-operative
timeFrame: 16-24 hours post-operative
measure: Gabapentin Consumption in Milligrams 24-48 Hours Post-operative
timeFrame: 24-48 hours post-operative
measure: Gabapentin Consumption in Milligrams 48-72 Hours Post-operative
timeFrame: 48-72 hours post-operative
measure: Ketorolac Consumption in Milligrams 0-4 Hours Post-operative
timeFrame: 0-4 hours post-operative
measure: Ketorolac Consumption in Milligrams 4-8 Hours Post-operative
timeFrame: 4-8 hours post-operative
measure: Ketorolac Consumption in Milligrams 8-16 Hours Post-operative
timeFrame: 8-16 hours post-operative
measure: Ketorolac Consumption in Milligrams 16-24 Hours Post-operative
timeFrame: 16-24 hours post-operative
measure: Ketorolac Consumption in Milligrams 24-48 Hours Post-operative
timeFrame: 24-48 hours post-operative.
measure: Ketorolac Consumption in Milligrams 48-72 Hours Post-operative
timeFrame: 48-72 hours post-operative
measure: Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative
timeFrame: 12-24 hours post-operative
measure: Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative
timeFrame: 24-48 hours post-operative
measure: Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative
timeFrame: 48-72 hours post-operative
measure: Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative
timeFrame: 0-4 hours post-operative
measure: Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative
timeFrame: 4-8 hours post-operative
measure: Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative
timeFrame: 8-12 hours post-operative
measure: Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative
timeFrame: 12-24 hours post-operative
measure: Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative
timeFrame: 24-48 hours post-operative
measure: Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative
timeFrame: 48-72 hours post-operative
measure: Length of Hospital Stay
timeFrame: From date of admission until date of discharge, an average of 72 hours
Other outcomes:
Locations:
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Poovendran Saththasivam, MD
role: PRINCIPAL_INVESTIGATOR
References: