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

Malignant Pleural Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044468
• Other study ID #: 2019-0237
• Secondary ID: NCI-2021-0895420
• Status: Recruiting
• Phase: Phase 2
• Start date: March 23, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Horiana Grosu, MD
• Phone: 713-792-6238
• Email: hbgrosu[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Pleural Neoplasm
• Pleural Neoplasms

Intervention

Drug:
• Lidocaine
Given via injection
• Liposomal Bupivacaine
Given via injection

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global chest pain score	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.	Through study completion, an average of 1 year

External Links

•   MD Anderson Cancer Center