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

A 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 Overview

• Status: Withdrawn
• Conditions: Pain
• Intervention / Treatment: Drug: lidocaine hydrochloride

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Drug: lidocaine hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improve pain management in patients undergoing pleuroscopy	pre-procedure and post procedure

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Lahey Clinic
• Investigators: Principal Investigator: David R Riker, MD, Lahey Clinic

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2008
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 2, 2008
• First Submitted That Met QC Criteria: June 5, 2008
• First Posted (Estimate): June 6, 2008

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 21, 2017
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Pain control
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: LCID 2008-007