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

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

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05044468

Enrollment

Registered

2021-09-14

Start date

2021-03-23

Completion date

2026-05-31

Last updated

2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Pleural Neoplasm

Brief 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.

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 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.

Interventions

DRUGLidocaine

Given via injection

DRUGLiposomal Bupivacaine

Given via injection

OTHERQuestionnaire Administration

Ancillary studies

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement 2. Age \> 18

Exclusion criteria

1. Inability to provide informed consent 2. Study subject has any disease or condition that interferes with safe completion of the 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

Design outcomes

Primary

Measure	Time frame	Description
Global chest pain score	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHoriana Grosu, MD

M.D. Anderson Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026