Trial Summary
What is the purpose of this trial?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.
Is the drug EXPAREL a promising treatment for pleural cancer?EXPAREL, a long-lasting pain relief drug, shows promise in reducing pain after surgery, which could be beneficial for pleural cancer patients.89111213
Do I have to stop taking my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications.
What safety data exists for EXPAREL vs Lidocaine in pleural cancer treatment?The provided research does not contain specific safety data for EXPAREL (Liposomal Bupivacaine) or Lidocaine in the treatment of pleural cancer. The studies focus on other treatments like bevacizumab and paclitaxel for malignant pleural effusions, evaluating their efficacy and safety. Therefore, no relevant safety data for EXPAREL or Lidocaine in pleural cancer is available in the given research.2461014
What data supports the idea that EXPAREL vs Lidocaine for Pleural Cancer is an effective drug?The available research does not provide specific data on the effectiveness of EXPAREL versus Lidocaine for Pleural Cancer. Instead, it focuses on other treatments for malignant pleural effusions, such as intrapleural chemotherapy with drugs like cisplatin and paclitaxel. These studies show that treatments like liposomal paclitaxel combined with cisplatin can be effective for non-small cell lung cancer with pleural effusions, but there is no direct comparison to EXPAREL or Lidocaine in the provided information.13457
Eligibility Criteria
This trial is for adults over 18 referred for pleuroscopy with biopsies and chest procedures, who can consent to treatment. It's not suitable for those allergic to EXPAREL or lidocaine, pregnant individuals, patients needing pleurodesis, or those with advanced liver disease.Inclusion Criteria
I am older than 18 years.
Exclusion Criteria
I need a procedure to close the space between my lung and chest wall.
Treatment Details
The study compares the effectiveness of two local anesthetics—EXPAREL and lidocaine—in providing comfort during pleuroscopy with biopsy and catheter placement in patients with pleural tumors or mesothelioma.
2Treatment groups
Experimental Treatment
Active Control
Group I: Group A (liposomal bupivacaine)Experimental Treatment2 Interventions
Patients receive liposomal bupivacaine via injection into the intercostal nerve block.
Group II: Group B (lidocaine)Active Control2 Interventions
Patients receive lidocaine via injection into the pleuroscopy port incision sites and indwelling pleural catheter site.
Find a clinic near you
Research locations nearbySelect from list below to view details:
M D Anderson Cancer CenterHouston, TX
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Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
References
[Results of phase III clinical trial of Pseudomonas jinanensis vaccine injection (PVI) in the treatment of malignant pleural effusion]. [2006]From April 1993 to September 1994, a prospective multicenter phase III clinical trial on PVI in the management of malignant effusion was carried out. Five hundred and nine patients, including 382 with lung cancer, 54 with breast cancer, 16 with malignant lymphoma, 57 with other malignancies complicated with pleural effusion were treated with intrapleural injections of PVI. The over-all response rate was 82.7% (421/509). For comparison, 41 patients with cancer of the lung (n = 31), breast (n = 6) and other sites (n = 4) also complicated with pleural effusion were treated by intrapleural PDD. The overall response rate in the latter treatment group was 61.0% (25/41). Fever and local pain were the major adverse reactions in the PVI treated patients while nausea, vomiting and myelosuppression in the PDD-treated control patients.
Phase II trial of intrapleural paclitaxel injection for non-small-cell lung cancer patients with malignant pleural effusions. [2021]A phase II clinical trial of intrapleural paclitaxel injection for malignant effusions of non-small-cell lung cancer (NSCLC) was conducted in order to evaluate the efficacy and toxicity profile of paclitaxel pleurodesis in patients with malignant effusions. From February to May of 1996, 15 NSCLC patients with malignant pleural effusions were enrolled on study. After adequate drainage and assurance of lung re-expansion, paclitaxel 125 mg m-2 diluted in normal saline was infused through a preinserted pig-tail catheter which was removed 2 h later. Chest radiography and sonography were scheduled 4 days later; depending on whether there remained a significant amount of pleural effusion, further drainage by needle thoracentesis or by a pig-tail catheter was performed. All patients were assessable for toxicity. Ipsilateral chest and/or shoulder pain, fever, facial flushing and nausea were the most frequent side-effects. Grade 4 neutropenia, grade 3 anaemia, and grade 3 renal impairment occurred in one patient each. Fourteen patients were evaluable for response at the end of the fourth week. Overall response rate of pleural effusion in evaluable patients was 92.9%, with a complete response rate of 28.6%. There was one out of 14 evaluable patients whose measurable tumour lesion decreased by more than 50% (partial response). No disease progression was noted among evaluable patients at the end of the fourth week. It is concluded that paclitaxel is a useful agent for the treatment of malignant pleural effusions. Because of its relatively low systemic toxicity, intrapleural paclitaxel injection in combination with systemic chemotherapy or radiotherapy can be considered in treating NSCLC patients with malignant pleural effusions.
Intrapleural administration of cisplatin and etoposide to treat malignant pleural effusions in patients with non-small cell lung cancer. [2017]To determine the efficacy, toxicity and pharmacokinetics of intrapleural cisplatin (CDDP) and etoposide as a treatment for malignant pleural effusions (MPE) in patients with non-small cell lung cancer (NSCLC).
A phase I clinical and pharmacokinetic study of paclitaxel liposome infused in non-small cell lung cancer patients with malignant pleural effusions. [2022]To investigate the feasibility, pharmacokinetics, efficacy and toxicity of intrapleural paclitaxel liposome injection in non-small cell lung cancer (NSCLC) patients with malignant pleural effusions.
Intrapleural chemotherapy with cisplatin and cytarabine in the management of malignant pleural effusion. [2021]The purpose of this study was to evaluate the efficacy of intrapleural chemotherapy (IPC) with cisplatin and cytarabine in the management of malignant pleural effusion (MPE) from non-small-cell lung cancer (NSCLC).
Intrapleural paclitaxel for malignant pleural effusion from ovarian and breast cancer: a phase II study with pharmacokinetic analysis. [2015]Malignant pleural effusion (MPE) is a frequent complication in many types of tumors diminishing the patient's ability to perform activities. Despite various studies on talc treatment, some doubts about its safety and effectiveness remain, so the search for a more ideal intrapleural agent continues. We analyzed the effectiveness and safety of intrapleural paclitaxel in ovarian and breast cancer patients.
Assessing the effectiveness and safety of liposomal paclitaxel in combination with cisplatin as first-line chemotherapy for patients with advanced NSCLC with regional lymph-node metastasis: study protocol for a randomized controlled trial (PLC-GC trial). [2022]Lung cancer is still the leading cause of cancer-related mortality worldwide. Around 80 to 85% of lung cancers are non-small cell lung cancer (NSCLC). Regional lymphatic metastasis is a frequent occurrence in NSCLC, and the extent of lymphatic dissemination significantly determines the prognosis of patients with NSCLC. Hence, identification of alternative treatments for these patients should be considered a priority. Liposomal paclitaxel is a new formulation composed of paclitaxel and liposomes, with favorable pharmacokinetic properties. In particular, it produces dramatically higher drug concentrations in the lymph nodes than occurs with the current formulations of paclitaxel, thus we believe that patients with NSCLC with regional lymphatic metastasis may benefit from this new drug. Cisplatin-based doublet chemotherapy is recommended as the first-line treatment for patients with advanced NSCLC. We have designed a trial to assess whether first-line chemotherapy using liposomal paclitaxel combined with cisplatin (LP regimen) is superior to gemcitabine combined with cisplatin (GP regimen) in efficacy (both short-term and long-term efficacy) and safety (adverse events; AEs).
Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]Liposome bupivacaine (Exparel) is a multivesicular liposomal formulation of bupivacaine currently approved in the United States for single-dose administration into the surgical site to provide postsurgical analgesia. This retrospective analysis examined safety data from clinical trials involving the off-label use of this formulation in peripheral nerve blocks.
Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. [2017]Medical studies have shown some potential for infiltrations of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, San Diego, CA), a slow-release bupivacaine solution, to extend postoperative benefits of numbness/pain relief for up to several days. Because the Food and Drug Administration has approved Exparel only for infiltrations, we wanted to evaluate if it would be effective as an infiltration to control postoperative pain. The purpose of this study was to compare an infiltration of bupivacaine with liposomal bupivacaine for postoperative numbness and pain in symptomatic patients diagnosed with pulpal necrosis experiencing moderate to severe preoperative pain.
Evaluation of efficacy and safety for bevacizumab in treating malignant pleural effusions caused by lung cancer through intrapleural injection. [2019]Some clinical investigations have assessed the efficacy and safety of bevacizumab combined with platinum anti-cancer drugs versus platinum drugs alone in treating malignant pleural effusion (MPE) caused by lung cancer through intrapleural injection. This report is a meta-analysis of independent research conclusions. Eleven controlled trials with 769 MPE patients were included in this report. Pooled odds ratios and standardized mean difference with 95% confidence intervals were estimated using the fixed or random effects model of meta-analysis. For treating MPE through intrapleural injection, bevacizumab combined with platinum chemotherapy drugs increased the overall response rate (p = 0.003), decreased the incidence of chest pain (p < 0.001) and relieved the dyspnea of patients with MPE (p = 0.002), as compared with platinum chemotherapy drugs alone. In addition, intrapleural injection of bevacizumab participation decreased the expression of vascular endothelial growth factor in MPE (p < 0.001). The main adverse effects of two groups were myelotoxicity, hypertension, digestive reaction and damage of liver and kidney. However, the presence of bevacizumab did not show an extra influence on the incidence of adverse effects (p > 0.05). In summary, bevacizumab combined with platinum chemotherapy drugs for treating MPE caused by lung cancer through intrapleural injection has a better benefit of overall response rate and quality of life. And, the participation of bevacizumab did not increase adverse effects.
Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. [2018]Liposomal bupivacaine (LB, Exparel) is a long-acting local anesthetic reported to decrease postoperative. The authors demonstrate the first safe use of LB in pediatric patients with improved pain control following pharyngoplasty.
Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]Liposomal bupivacaine (Exparel®) is a sustained-release formulation of bupivacaine for use in surgical infiltration anaesthesia. We analysed the histological nerve toxicity and clinical effectiveness of perineural Exparel® alone or with added dexamethasone in a mouse model.
Liposomal bupivacaine use in exploratory lingual nerve microsurgery: does liposomal bupivacaine use decrease postoperative pain and opioid consumption compared to bupivacaine hydrochloride? A pilot study. [2021]The purpose of this study was to determine if liposomal bupivacaine 1.3% (LB), Exparel (Pacira Pharmaceuticals), is more effective than bupivacaine hydrochloride 0.25% (BH), Marcaine (Hospira), in reducing postoperative pain and opioid consumption in patients undergoing exploratory lingual nerve microsurgery. The investigators hypothesized that patients who received LB would have a greater reduction in acute postoperative pain, and therefore, a reduction in total opioid use over 72 hours postoperatively.
Efficacy of Intrapleural or Intrapericardial Injection of Single Bevacizumab in the Treatment of Lung Cancer-Mediated Malignant Effusion. [2022]The usage of bevacizumab for malignant pleural effusion (MPE) or malignant pericardial effusion (MPCE) has attracted increasing interest from researchers, but the precise ways of bevacizumab administration remain unknown. Patients with histologically or cytologically confirmed non-small-cell lung cancer (NSCLC) with MPE or MPCE were enrolled in the study and treated with a low dose of single bevacizumab (100 mg) intrapleurally or intrapericardially injected after the drainage of the effusions. The Lung Cancer Symptom Scale (LCSS), efficacy, and safety of drug administration were used as evaluation parameters in this study. The results indicated that lung cancer-related symptoms were significantly improved following treatment, compared with symptoms before the treatment (LCSS, score 494 ± 78 vs. score 377 ± 77, mean ± SD) (P < 0.001). Malignant effusions were well controlled, and the median time to progression (TTP) was 91 days and 111 days in MPE and MPCE, respectively. In addition, no severe side effects were observed, except in one patient with mild dizziness. In summary, the low dose of single bevacizumab (100 mg) with intrapleural or intrapericardial injection is effective and safe in the treatment of lung cancer-mediated malignant effusion, rapidly improving the malignant effusion-related symptoms and quality of life in patients with NSCLC.