Pain
Conditions
Keywords
Pain control
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.
Interventions
DRUGlidocaine 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
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improve pain management in patients undergoing pleuroscopy | pre-procedure and post procedure |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed