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

Poovendran Saththasivam

Status and phase: Terminated; Phase 2

Conditions: Thoracic Surgery

Treatments: Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine; Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)

Study type: Interventional

Funder types: Other

Identifiers

NCT04559347

2007-48

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Experimental group

Description:

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic

Treatment:

Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Continuous catheter infusion ropivacaine

Active Comparator group

Description:

Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic

Treatment:

Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)