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
Overview
- Phase
- Phase 2
- Intervention
- Liposomal Bupivacaine
- Conditions
- Malignant Pleural Neoplasm
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Global chest pain score
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement
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.
- •Advanced liver disease where the clinician deems the procedure unsafe
Arms & Interventions
Group A (liposomal bupivacaine)
Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
Intervention: Liposomal Bupivacaine
Group A (liposomal bupivacaine)
Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
Intervention: Questionnaire Administration
Group B (lidocaine)
Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
Intervention: Lidocaine
Group B (lidocaine)
Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
Intervention: Questionnaire Administration
Outcomes
Primary Outcomes
Global chest pain score
Time Frame: 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.