Text Size

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

This study has been terminated.
(Principal Investigator left the institution requested termination)
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00693043
First received: June 2, 2008
Last updated: April 16, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Pain
 Drug: lidocaine hydrochloride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Improve pain management in patients undergoing pleuroscopy [ Time Frame: pre-procedure and post procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: February 2008
Study Completion Date: February 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00693043

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

No publications provided

Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00693043     History of Changes
Other Study ID Numbers: LCID 2008-007
Study First Received: June 2, 2008
Last Updated: April 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Pain control

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013