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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: April 1, 2023

Detailed Description

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% 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% 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% lidocaine. III. To compare the number of narcotics within 24 hours, and from 24 to 48 hours post procedure between EXPAREL and1% 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.

Interventions

  • Drug: Lidocaine
    • Given via injection
  • Drug: Liposomal Bupivacaine
    • Given via injection
  • Other: Questionnaire Administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Group A (liposomal bupivacaine)
    • Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
  • Active Comparator: Group B (lidocaine)
    • Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.

Clinical Trial Outcome Measures

Primary Measures

  • Global chest pain score
    • Time Frame: Through study completion, an average of 1 year
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Referral to pulmonary services for pleuroscopy with biopsies and indwelling pleural catheter (IPC) 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: – Allergic reaction to EXPAREL – Need for pleurodesis – No placement if IPC – Previous ipsilateral thoracic surgery – Allergies to lidocaine or other local anesthetics, narcotics, non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen – Pregnancy – Advanced liver disease where the clinician deems the procedure unsafe

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • M.D. Anderson Cancer Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Horiana Grosu, Principal Investigator, M.D. Anderson Cancer Center

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