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

Last updated: March 21, 2025
Sponsor: M.D. Anderson Cancer Center
Overall Status: Active - Recruiting

Phase

2

Condition

Pleural Diseases

Treatment

Liposomal Bupivacaine

Questionnaire Administration

Lidocaine

Clinical Study ID

NCT05044468
2019-0237
2019-0237
NCI-2021-08954
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chesttube placement

  2. Age > 18

Exclusion

Exclusion criteria:

  1. Inability to provide informed consent

  2. Study subject has any disease or condition that interferes with safe completion ofthe study including: a. Allergic reaction to EXPAREL

  3. Need for pleurodesis

  4. Allergies to lidocaine or other local anesthetics.

  5. Pregnancy

  6. Advanced liver disease where the clinician deems the procedure unsafe

Study Design

Total Participants: 80
Treatment Group(s): 3
Primary Treatment: Liposomal Bupivacaine
Phase: 2
Study Start date:
March 23, 2021
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • M D Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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