Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether administration of a pectoral nerve blocks (Pecs I and II) with 0.25% bupivacaine are more effective as compared to placebo to provide analgesia for cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

• Patients 18 years of age or older

• Undergoing CIED placement in electrophysiology lab

• Booked with anesthesia service for the procedure.

Exclusion Criteria:

• Current participation in another interventional study

• Use of mechanical circulatory support device

• Emergent procedures

• Patients receiving other modalities of regional anesthesia like intrathecal morphine

• Chronic opioid use for chronic pain conditions with tolerance (total daily dose of an opioid at or more than 30 mg morphine equivalent for more than one month within the past year)

• Current use of SSRI, TCA, anti-epileptics, gabapentin, or pregabalin

• Hypersensitivity to bupivacaine

• Hemodynamics related: Oxygenation outside of normal limits (defined as PaO2 < 60mmHg on an FiO2 of 1.0 or SpO2 < 85% within 30 minutes prior to drug administration), Received an infusion or bolus ≥ 0.05 mcg/kg/min of epinephrine o Received an infusion or bolus ≥ 0.50 mcg/kg/min of milrinone, Received an infusion or bolus ≥ 0.20 mcg/kg/min of norepinephrine o Significant clinician or nursing concern, Hemodynamically unstable (defined as HR > 120, SBP < 80, MAP < 50 within 30 minutes prior to drug administration)