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

NCT ID: NCT00693043

Last Updated: 2017-12-26

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-05-31

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.

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.

Conditions

Pain

Keywords

Pain control

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

lidocaine hydrochloride

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Drug: lidocaine hydrochloride

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahey Clinic

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David R Riker, MD

Role: PRINCIPAL_INVESTIGATOR

Lahey Clinic

Locations

Lahey Clinic

Burlington, Massachusetts, United States

Countries

United States

Other Identifiers

LCID 2008-007

Identifier Type: -

Identifier Source: org_study_id