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

  • STATUS
    Recruiting
  • participants needed
    80
  • sponsor
    M.D. Anderson Cancer Center
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Updated on 15 September 2021
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Summary

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.

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.

Details
Condition Malignant Pleural Neoplasm
Age 18years - 100years
Treatment Lidocaine, Questionnaire Administration, Liposomal Bupivacaine
Clinical Study IdentifierNCT05044468
SponsorM.D. Anderson Cancer Center
Last Modified on15 September 2021

Eligibility

 Yes No Not Sure

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
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