Pain Management in Response to Exparel vs. Standard Bupivicaine (VATS Exparel)

Inova Health Care Services

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Liposomal Bupivicaine; Drug: 0.25% standard bupivicaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02499159

14-1656

Details and patient eligibility

About

This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.

Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.

Full description

Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.

It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.

Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.

Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients over 18 years of age
• Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

Exclusion criteria

• Previous ipsilateral thoracic surgery
• Need for operative pleurectomy or pleurodesis
• Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics
• Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
• Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
• Renal dysfunction (eGFR < 60ml/min/1.73m2)
• History of peptic ulcerative disease
• Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation
• Inability to consent
• Pregnancy
• Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy
• Patient is discharged from the hospital with a chest tube in place
• Patient fails to comply with post-operative instructions

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Exparel

Experimental group

Description:

Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.

Treatment:

Drug: Liposomal Bupivicaine

0.25% standard bupivicaine

Active Comparator group

Description:

Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.

Treatment:

Drug: 0.25% standard bupivicaine