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

Phase 2

Recruiting

• Conditions: Malignant Pleural Neoplasm
• Interventions: Drug: Lidocaine; Drug: Liposomal Bupivacaine; Other: Questionnaire Administration

• Registration Number: NCT05044468
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study Start: 2021-03-23
• Study First Submitted: 2021-09-02
• Study First Submitted QC: 2021-09-13
• Study First Posted: 2021-09-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B (lidocaine)	Lidocaine	Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
Group B (lidocaine)	Questionnaire Administration	Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
Group A (liposomal bupivacaine)	Questionnaire Administration	Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
Group A (liposomal bupivacaine)	Liposomal Bupivacaine	Patients receive liposomal bupivacaine via injection into the intercostal nerve block.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States