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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00693043
• Other study ID #: LCID 2008-007
• Status: Withdrawn
• Phase: N/A
• First received: June 2, 2008
• Last updated: December 21, 2017
• Start date: February 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2014
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• lidocaine hydrochloride
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

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve pain management in patients undergoing pleuroscopy		pre-procedure and post procedure
Secondary	Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120		time of procedure will be documented;lidocaine levels monitored throught out