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

Study Overview
=================
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.

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

Conditions
-----------------
Thoracic Surgery

Intervention / Treatment
-----------------
* Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
* Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine<br>Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic | Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine<br>* Single shot for erector spinae block<br>* Other names: EXPAREL®/Bupivacaine;|
| Active Comparator: Continuous catheter infusion ropivacaine<br>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)<br>* Continuous catheter infusion for erector spinae plane block<br>* Other names: Ropivacaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rated Pain Scale (NRP) | Patient reported pain scale (0-10) | 3 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative opioid consumption | Post-operative opioid consumption in morphine equivalents to determine total morphine. | 3 days post-operative | 
| Total Intraoperative narcotic | Total opioids administered in the operating room surgery in morphine equivalents. | At end of surgery | 
| Total adjunct pain medication consumption | Non-narcotic pain medications such as acetaminophen, gabapentin, ketorolac, etc. | 3 days post-operative | 
| Incentive spirometry changes from preoperative baseline to 3 days post-operative | Incentive spirometry change from preoperative baseline to 3 days post-operative | 3 days post-operative | 
| Length of hospital stay | Number of days from admission to discharge | From date of admission until date of discharge, an average of 3 days | 
| Postoperative Quality of Recovery score (QOR-15) | 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. | 3 days post-operative | 
| Adverse events frequency | 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 | up to 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thoracic surgery