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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-23

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Malignant Pleural Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A (liposomal bupivacaine)

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

Group Type EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type DRUG

Given via injection

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Group B (lidocaine)

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

Group Type ACTIVE_COMPARATOR

Lidocaine

Intervention Type DRUG

Given via injection

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Lidocaine

Given via injection

Intervention Type DRUG

Liposomal Bupivacaine

Given via injection

Intervention Type DRUG

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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.omega.-Diethylamino-2,6-dimethylacetanilide 2-(Diethylamino)-2'',6''-acetoxylidide Cuivasil Duncaine Leostesin Lidothesin Lignocaine Rucaina Bupivacaine Liposome Injectable Suspension Exparel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No