Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery
- Conditions
- Thoracic Surgery
- Interventions
- Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
- Registration Number
- NCT04559347
- Lead Sponsor
- Poovendran Saththasivam
- 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 74
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine Liposomal Bupivacaine (EXPAREL®)/Bupivacaine Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic Continuous catheter infusion ropivacaine Ropivacaine (0.5% bolus followed by 0.2% infusion) Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
- Primary Outcome Measures
Name Time Method Numerical Rated Pain Scale (NRP) 3 days post-operative Patient reported pain scale (0-10)
- Secondary Outcome Measures
Name Time Method Post-operative opioid consumption 3 days post-operative Post-operative opioid consumption in morphine equivalents to determine total morphine.
Total Intraoperative narcotic At end of surgery Total opioids administered in the operating room surgery in morphine equivalents.
Total adjunct pain medication consumption 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 3 days post-operative Incentive spirometry change from preoperative baseline to 3 days post-operative
Length of hospital stay 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) 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 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
Trial Locations
- Locations (1)
Robert Packer Hospital
🇺🇸Sayre, Pennsylvania, United States