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

M.D. Anderson Cancer Center

Status and phase: Active, not recruiting; Phase 2

Conditions: Malignant Pleural Neoplasm

Treatments: Drug: Liposomal Bupivacaine; Drug: Lidocaine; Other: Questionnaire Administration

Study type: Interventional

Funder types: Other

Identifiers

NCT05044468

NCI-2021-08954 (Registry Identifier)

2019-0237

Details and patient eligibility

About

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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Group A (liposomal bupivacaine)

Experimental group

Description:

Patients receive liposomal bupivacaine via injection into the intercostal nerve block.

Treatment:

Other: Questionnaire Administration

Drug: Liposomal Bupivacaine

Group B (lidocaine)

Active Comparator group

Description:

Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.

Treatment:

Other: Questionnaire Administration

Drug: Lidocaine