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

Lahey Health

Status: Withdrawn

Conditions: Pain

Treatments: Drug: lidocaine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT00693043

LCID 2008-007

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Standard anesthesia group

No Intervention group

Description:

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.

Lidocaine Group

Experimental group

Description:

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.

Treatment:

Drug: lidocaine hydrochloride