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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693043
Recruitment Status : Withdrawn (Principal Investigator left the institution requested termination)
First Posted : June 6, 2008
Last Update Posted : December 26, 2017
Information provided by (Responsible Party):
Lahey Clinic

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.

Condition or disease Intervention/treatment Phase
Pain Drug: lidocaine hydrochloride Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy
Actual Study Start Date : February 2008
Actual Primary Completion Date : March 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Improve pain management in patients undergoing pleuroscopy [ Time Frame: pre-procedure and post procedure ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00693043

United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Principal Investigator: David R Riker, MD Lahey Clinic

Responsible Party: Lahey Clinic Identifier: NCT00693043     History of Changes
Other Study ID Numbers: LCID 2008-007
First Posted: June 6, 2008    Key Record Dates
Last Update Posted: December 26, 2017
Last Verified: March 2014

Keywords provided by Lahey Clinic:
Pain control

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action