Clinical trial NCT05044468: EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Malignant Pleural Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion criteria:

1. Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement
2. Age \> 18

Exclusion criteria:

1. Inability to provide informed consent
2. Study subject has any disease or condition that interferes with safe completion of the study including:

   a. Allergic reaction to EXPAREL
3. Need for pleurodesis
4. Allergies to lidocaine or other local anesthetics.
5. Pregnancy
6. Advanced liver disease where the clinician deems the procedure unsafe

Primary outcomes:
measure: Global chest pain score
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Horiana Grosu, MD
role: PRINCIPAL_INVESTIGATOR
References: