Pilot Study About Safety and Efficacy of Atomized Intrapleural Lidocaine During Pleuroscopy
Information source: Lahey Clinic
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: lidocaine hydrochloride (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Lahey Clinic Official(s) and/or principal investigator(s):
David R Riker, MD, Principal Investigator, Affiliation: Lahey Clinic
Overall contact:
David R Riker, MD, Phone: 781-744-3947, Email: David.R.Riker@Lahey.org
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.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
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
Locations and Contacts
David R Riker, MD, Phone: 781-744-3947, Email: David.R.Riker@Lahey.org
Lahey Clinic, Burlington, Massachusetts 01805, United States; Recruiting
David R Riker, MD, Phone: 781-744-3947, Email: David.R.Riker@Lahey.org
Janet Polcaro, RN, Phone: 781-744-8027, Email: Janet.Polcaro@Lahey.org
David R Riker, MD, Principal Investigator
Additional Information
Starting date: February 2008
Last updated: July 12, 2010
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