search
Back to results

EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement

Primary Purpose

Malignant Pleural Neoplasm

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Liposomal Bupivacaine
Questionnaire Administration
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Pleural Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A (liposomal bupivacaine)

Group B (lidocaine)

Arm Description

Patients receive liposomal bupivacaine via injection into the intercostal nerve block.

Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2021
Last Updated
September 22, 2023
Sponsor
M.D. Anderson Cancer Center
search

1. Study Identification

Unique Protocol Identification Number
NCT05044468
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2021 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Pleural Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (liposomal bupivacaine)
Arm Type
Experimental
Arm Description
Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
Arm Title
Group B (lidocaine)
Arm Type
Active Comparator
Arm Description
Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
.omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, Rucaina
Intervention Description
Given via injection
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivacaine
Other Intervention Name(s)
Bupivacaine Liposome Injectable Suspension, Exparel
Intervention Description
Given via injection
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Global chest pain score
Description
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.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement Age > 18 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Horiana Grosu, MD
Phone
713-792-6238
Email
hbgrosu@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Horiana Grosu, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Horiana Grosu
Phone
713-792-6238
Email
hbgrosu@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Horiana Grosu

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
MD Anderson Cancer Center

Learn more about this trial

EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement

We'll reach out to this number within 24 hrs