Malignant Pleural NeoplasmPhase 2NCT05044468
EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement
A Phase 2 study testing Lidocaine, Liposomal Bupivacaine and Questionnaire Administration in people with Malignant Pleural Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Neoplasm
- What is being tested?
- Lidocaine, Liposomal Bupivacaine and Questionnaire Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2021to 31 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement
- Age > 18
Who cannot join
- Inability to provide informed consent
- Study subject has any disease or condition that interferes with safe completion of the study including:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Malignant Pleural Neoplasm
- Being tested
- Lidocaine, Liposomal Bupivacaine, Questionnaire Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, Duncaine
Given via injection
Liposomal BupivacaineDrug
Also called Bupivacaine Liposome Injectable Suspension, Exparel
Given via injection
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group A (liposomal bupivacaine) | Experimental | Patients receive liposomal bupivacaine via injection into the intercostal nerve block. Receives: Drug: Liposomal Bupivacaine; Other: Questionnaire Administration |
| Group B (lidocaine) | Active comparator | Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site. Receives: Drug: Lidocaine; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start23 Mar 2021
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Pleural NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horiana Grosu, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05044468
- Sponsor's protocol ID
- 2019-0237
- Other IDs
- NCI-2021-08954, 2019-0237
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2021
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05044468
- Acronym / sponsor ID
- 2019-0237
- Conditions
- Malignant Pleural Neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (liposomal bupivacaine) | Experimental | Drug: Liposomal Bupivacaine, Other: Questionnaire AdministrationPatients receive liposomal bupivacaine via injection into the intercostal nerve block. |
| Group B (lidocaine) | Active comparator | Drug: Lidocaine, Other: Questionnaire AdministrationPatients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referral to pulmonary services for pleuroscopy with biopsies and IPC placement/chest tube placement
- Age > 18
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Need for pleurodesis
- Allergies to lidocaine or other local anesthetics.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, DuncaineGiven via injection | Drug | Group B (lidocaine) |
| Liposomal BupivacaineAlso: Bupivacaine Liposome Injectable Suspension, ExparelGiven via injection | Drug | Group A (liposomal bupivacaine) |
| Questionnaire AdministrationAncillary studies | Other | Group A (liposomal bupivacaine), Group B (lidocaine) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Malignant Pleural Neoplasm
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
RecruitingPhase 2
The Diagnostic Accuracy and Clinical Value of FAPI PET in Pleural Mesothelioma
Pleural Mesothelioma, Pleural Diseases
Active, not recruitingPhase 1
Safety and Preliminary Antitumor Activity of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Horiana Grosu, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine, Liposomal Bupivacaine and Questionnaire Administration in people with Malignant Pleural Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global chest pain score (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.