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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-08954 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 2019-0237 | Other Identifier | M D Anderson Cancer Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (liposomal bupivacaine) | Experimental | Patients receive liposomal bupivacaine via injection into the intercostal nerve block. |
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| Group B (lidocaine) | Active Comparator | Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Given via injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion criteria:
Inability to provide informed consent
Study subject has any disease or condition that interferes with safe completion of the study including:
a. Allergic reaction to EXPAREL
Need for pleurodesis
Allergies to lidocaine or other local anesthetics.
Pregnancy
Advanced liver disease where the clinician deems the procedure unsafe
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| Name | Affiliation | Role |
|---|---|---|
| Horiana Grosu, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Liposomal Bupivacaine | Drug | Given via injection |
|
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| Questionnaire Administration | Other | Ancillary studies |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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