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

NCT05044468 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2019-0237NCI-2021-08954
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Pleural Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 1 year

Study Arms (2)

Group A (liposomal bupivacaine)

EXPERIMENTAL

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

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.

Drug: Lidocaine; Other: Questionnaire Administration

Interventions

Lidocaine DRUG

Given via injection

Also known as: .omega.-Diethylamino-2,6-dimethylacetanilide, 2-(Diethylamino)-2'',6''-acetoxylidide, Cuivasil, Duncaine, Leostesin, Lidothesin, Lignocaine, Rucaina

Group B (lidocaine)

Liposomal Bupivacaine DRUG

Given via injection

Also known as: Bupivacaine Liposome Injectable Suspension, Exparel

Group A (liposomal bupivacaine)

Questionnaire Administration OTHER

Ancillary studies

Group A (liposomal bupivacaine); Group B (lidocaine)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Horiana Grosu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 14, 2021
• Study Start: March 23, 2021
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)