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

Not Applicable

Withdrawn

• Conditions: Pain
• Interventions: Drug: lidocaine hydrochloride

• Registration Number: NCT00693043
• Lead Sponsor: Lahey Clinic

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-02
• Study First Submitted QC: 2008-06-05
• Study First Posted: 2008-06-06
• Primary Completion: 2010-03
• Study Completion: 2010-05
• Status Verified: 2014-03
• Last Update Submitted: 2017-12-21
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine Group	lidocaine hydrochloride	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.

Primary Outcome Measures

Name	Time	Method
Improve pain management in patients undergoing pleuroscopy	pre-procedure and post procedure

Secondary Outcome Measures

Name	Time	Method
Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120	time of procedure will be documented;lidocaine levels monitored throught out

Trial Locations

Locations (1)

Lahey Clinic; 🇺🇸 Burlington, Massachusetts, United States