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

Information source: Lahey Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: lidocaine hydrochloride (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Lahey Clinic

Official(s) and/or principal investigator(s):
David R Riker, MD, Principal Investigator, Affiliation: Lahey Clinic


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Improve pain management in patients undergoing pleuroscopy

Secondary outcome: Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120

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.


Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.


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

Locations and Contacts

Lahey Clinic, Burlington, Massachusetts 01805, United States
Additional Information

Starting date: February 2008
Last updated: March 26, 2014

Page last updated: August 23, 2015

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