Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy

Study Overview
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Brief Summary
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This study will evaluate the potential to decrease the use of IV anesthesia drugs in patients undergoing pleuroscopy administering lidocane standardly applied to the skin in combination with atomized lidocaine applied into the pleural cavity.

Detailed Description
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Most patient discomfort results from direct manipulation or contact with the parietal pleura during chest tube placement, talc instillation or pleural biopsy. This study intends to use combined IV, intradermal and intrapleural anesthesia during pleuroscopy procedures. Intrapleural atomized lidocaine will be applied directly to the parital pleura. This study will evaluate intravenous anesthesia reduction in subjects treated with intrapleural lidocaine, reduction in total procedure timeby minimizing interruptions due to poor pain control, reduce perioperative pain scores and improve patient comfort nad to determine safety of fixed dosage of 3 mg/kg intrapleural lidocaine given during pleuroscopy.

Official Title
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A Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy

Conditions
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Pain

Intervention / Treatment
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* Drug: lidocaine hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with pleural disease Patients undergoing pleuroscopy with talc with or w/o biopsy Patients aged 18 - 85 Patients capable of signing informed consent Exclusion Criteria: Severe congestive heart failure Hepatic failure, bilirubin > 2mg/dl, ALT,AST 3XULN Prior use Lidocaine in 48 hrs Hx SA drug reaction to lidocaine or amide local anesthetics Second or third degree heart block (w/o pacemaker) Sever sinoatrial block (w/o pacemaker) Concurrent treatment with quinidine, flecainide, dsopyramide, procainamide (ClassI antirrhythmic agents) Prior use or amiodarone hydrochloride systolic BP < 90mmHg bradycardia accelerated idioventricular rhythm

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard anesthesia group<br>Patients randomized to arm 1 received standard of care anesthesia for pleuroscopy. Duration of the procedure will be recorded. Pain management will be monitored prior to, intraoperatively and at the end of the procedure. | |
| Experimental: Lidocaine Group<br>Patients randomized to arm two will receive a reduced topical dose of lidocaine of 2mg/kg and additional lidocaine 3mg/kg infused into the pleura cavity. Duration of procedure will be monitored from the time initial dose of intradermal lidocaine until the start of surgical wound closing, pain scale will be administered prior to the procedure and at the end of the procedure. Lidocaine serum levels will be monitored at 30, 60, and 120 minutes after initial intradermal administration of lidocaine. | Drug: lidocaine hydrochloride<br>* Study group will have up to 2 mg/kg of Lidocaine administered to the skin and additional Lidocaine(3mg/kg)infused through an atomizer using a specialized tip attached to the sterile leur lock syringe into the pleural cavity. The Intrapleural lidocaine dose will be given in a fixed dose of 3 mg/kg. Serum levels will be obtained at 30, 60, and 120 minutes after initial intradermal administration<br>* Other names: Drug: lidocaine hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve pain management in patients undergoing pleuroscopy |  | pre-procedure and post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120 |  | time of procedure will be documented;lidocaine levels monitored throught out | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain control