This phase II trial investigates the effect of EXPAREL compared to lidocaine 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 lidocaine is able to make patients more comfortable.
Additional locations may be listed on ClinicalTrials.gov for NCT05044468.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Horiana Grosu
Phone: 713-792-6238
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% 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% 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% lidocaine.
III. To compare the number of narcotics within 24 hours, and from 24 to 48 hours post procedure between EXPAREL and1% 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/chest tube site (IPC).
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorHoriana Grosu