Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||A Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy|
- Improve pain management in patients undergoing pleuroscopy [ Time Frame: pre-procedure and post procedure ] [ Designated as safety issue: No ]
- Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120 [ Time Frame: time of procedure will be documented;lidocaine levels monitored throught out ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2008|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
No Intervention: Standard anesthesia group
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
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
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
Other Name: Drug: lidocaine hydrochloride
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693043
|United States, Massachusetts|
|Burlington, Massachusetts, United States, 01805|
|Principal Investigator:||David R Riker, MD||Lahey Clinic|