Comparing EXPAREL and lidocaine for pain relief during pleuroscopy procedures
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
PHASE2 · M.D. Anderson Cancer Center · NCT05044468
This study is testing whether a new pain relief medication called EXPAREL works better than the standard lidocaine for people having a pleuroscopy procedure.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05044468 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the effectiveness of EXPAREL, a liposomal formulation of bupivacaine, compared to traditional lidocaine as a local anesthetic for patients undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. The study aims to measure and compare post-procedural chest pain using visual analog and numerical rating scales at various time points. Patients are randomized into two groups, receiving either EXPAREL or lidocaine, to assess pain relief and narcotic usage following the procedure.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 referred for pleuroscopy with biopsies and indwelling pleural catheter placement.
Not a fit: Patients with allergies to EXPAREL or lidocaine, or those with conditions that make the procedure unsafe, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide improved pain management options for patients undergoing pleuroscopy, enhancing their comfort and recovery experience.
How similar studies have performed: Previous studies have shown promising results with liposomal bupivacaine in various surgical settings, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Horiana Grosu, MD — M.D. Anderson Cancer Center
- Study coordinator: Horiana Grosu, MD
- Email: hbgrosu@mdanderson.org
- Phone: 713-792-6238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Malignant Pleural Neoplasm