Pain Management in Response to Exparel vs. Standard Bupivicaine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy

Conditions
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Pain

Intervention / Treatment
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* Drug: Liposomal Bupivicaine
* Drug: 0.25% standard bupivicaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exparel<br>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. | Drug: Liposomal Bupivicaine<br>* 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.<br>* Other names: Exparel;|
| Active Comparator: 0.25% standard bupivicaine<br>Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. | Drug: 0.25% standard bupivicaine<br>* standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.<br>* Other names: Bupivicaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 | Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets. | Assessed daily for 7 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scores on a Analog Pain Scale (7 Days) | Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. | Assessed at day 7 post-procedure | 
| Scores on an Analog Pain Scale (30 Days) | Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. | Assessed at 30 days post-procedure | 
| Number of Patients With Paresthesias (Postoperatively at 7 Days) | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure. | Assessed at day 7 post-procedure | 
| Proportion of Patients With Paresthesias (Postoperatively at 30 Days) | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves | Assessed at day 30 post-procedure | 
| Hospital Length of Stay | Median length of stay in days until discharge. | From end of procedure until discharge, usually 0-2 days. | 
| Return to Baseline Activity | Using surveys, patients are asked if they have been able to return to baseline activity levels. | Assessed at 30 days post-procedure | 
| Return to Work | Using surveys, patients are asked if they have been able to return to work. | Assessed at 30 days post-procedure | 
| Days Until Return to Work | Using surveys, the number of days to return to work was assessed for patients who were able to return to work. | Assessed at 30 days post-procedure | 
| Overall Hospital Cost | Overall hospital cost of patient procedure and stay will be assessed. | Total cost assessed from patient registration until discharge to home (usually 0-2 days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exparel, Thoracoscopy, Bupivicaine, Liposomal