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EXPAREL vs Lidocaine for Pleural Cancer

Phase 2
Recruiting
Led By Horiana Grosu
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18
Be older than 18 years old
Must not have
Need for pleurodesis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

This trial compares the effect of two local anesthetics, EXPAREL and lidocane, on patients undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. The goal is to see which anesthetic makes patients more comfortable.

Who is the study for?
This trial is for adults over 18 referred for pleuroscopy with biopsies and chest procedures, who can consent to treatment. It's not suitable for those allergic to EXPAREL or lidocaine, pregnant individuals, patients needing pleurodesis, or those with advanced liver disease.
What is being tested?
The study compares the effectiveness of two local anesthetics—EXPAREL and lidocaine—in providing comfort during pleuroscopy with biopsy and catheter placement in patients with pleural tumors or mesothelioma.
What are the potential side effects?
Possible side effects include reactions at the injection site such as pain, swelling, redness; systemic reactions like allergies; and other side effects that are specific to each medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need a procedure to close the space between my lung and chest wall.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain

Side effects data

From 2023 Phase 4 trial • 105 Patients • NCT04258631
2%
Spinal headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone)
Arm I (Laparotomy, Liposomal Bupivacaine)

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group A (liposomal bupivacaine)Experimental Treatment2 Interventions
Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
Group II: Group B (lidocaine)Active Control2 Interventions
Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,065 Previous Clinical Trials
1,802,144 Total Patients Enrolled
Horiana GrosuPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
97 Total Patients Enrolled
Horiana Grosu, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Liposomal Bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT05044468 — Phase 2
Malignant Pleural Mesothelioma Research Study Groups: Group B (lidocaine), Group A (liposomal bupivacaine)
Malignant Pleural Mesothelioma Clinical Trial 2023: Liposomal Bupivacaine Highlights & Side Effects. Trial Name: NCT05044468 — Phase 2
Liposomal Bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT05044468 — Phase 2
~19 spots leftby Jan 2026
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