EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement

Study Overview
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Brief Summary
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This phase II trial investigates the effect of EXPAREL compared to lidocane as a local anesthetic in patients who are undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. This trial aims to see whether EXPAREL or lidocane is able to make patients more comfortable.

Detailed Description
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PRIMARY OBJECTIVE: I. To compare Global chest pain score (measured on the Visual Analog Scale [VAS] scale) post-procedure and post procedural chest pain (measured on the numerical rating scale), at the time of discharge from recovery between liposomal bupivacaine (EXPAREL) and 1 percent lidocaine. SECONDARY OBJECTIVES: I. To compare post procedural chest pain (measured on the numerical rating scale) at the time of discharge from recovery, 24 hours and 48 hours post procedure between EXPAREL and 1 percent lidocaine. II. To assess the change in global chest pain score (measured on the VAS scale) from baseline to the time of discharge from recovery, and post procedural chest pain (measured on the numerical rating scale) from baseline over time between EXPAREL and 1 percent lidocaine. III. To compare the number of narcotics within 24 hours, and from 24 to 48 hours post procedure between EXPAREL and 1 percent lidocaine. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP A: Patients receive liposomal bupivacaine via injection into the intercostal nerve block. GROUP B: Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.

Official Title
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A Randomized Blinded Controlled Trial of EXPAREL vs 1% Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement

Conditions
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Malignant Pleural Neoplasm

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Liposomal Bupivacaine
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement Age > 18 Exclusion criteria: Inability to provide informed consent Study subject has any disease or condition that interferes with safe completion of the study including: a. Allergic reaction to EXPAREL Need for pleurodesis Allergies to lidocaine or other local anesthetics. Pregnancy Advanced liver disease where the clinician deems the procedure unsafe

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (liposomal bupivacaine)<br>Patients receive liposomal bupivacaine via injection into the intercostal nerve block. | Drug: Liposomal Bupivacaine<br>* Given via injection<br>* Other names: Exparel;Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Group B (lidocaine)<br>Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site. | Drug: Lidocaine<br>* Given via injection<br>* Other names: Rucaina;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global chest pain score | Will be evaluated by the Global chest pain score at the time of discharge from recovery area using a Visual Analog Scale 0-100 and represents the pain experienced by the patient. | Through study completion, an average of 1 year |