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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    80
  • sponsor
    M.D. Anderson Cancer Center
Updated on 16 October 2022

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 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.

Details
Condition Malignant Pleural Neoplasm
Treatment questionnaire administration, lidocaine, Liposomal bupivacaine
Clinical Study IdentifierNCT05044468
SponsorM.D. Anderson Cancer Center
Last Modified on16 October 2022

Eligibility

Yes No Not Sure

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
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
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