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

NCT00693043 | Withdrawn

• 1 other identifier: LCID 2008-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Pain control

Outcome Measures

Primary Outcomes (1)

• Improve pain management in patients undergoing pleuroscopy

  pre-procedure and post procedure

Secondary Outcomes (1)

• Reduction of procedure time Measurement of lidocaine serum levels at 30, 60, 120

  time of procedure will be documented;lidocaine levels monitored throught out

Study Arms (2)

Standard anesthesia group

NO INTERVENTION

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

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

Interventions

lidocaine hydrochloride DRUG

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

Also known as: Drug: lidocaine hydrochloride

Lidocaine Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• David R Riker, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2008
• First Posted: June 6, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 26, 2017

Record last verified: 2014-03

Locations

US (1)