NCT00693043

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lahey Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2008-06-06
• Last updated: 2017-12-26

Locations

1 site across 1 country: United States