Status:
ACTIVE_NOT_RECRUITING
Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Pain, Postoperative
Pain, Acute
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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 ca...
Detailed Description
Cardiovascular implantable electrical device (CIED) is a generalized term for pacemakers, implantable cardiac devices (ICDs) and cardiac resynchronization therapy (CRT) devices. CRT is a modality of c...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older
- Undergoing CIED placement in electrophysiology lab
- Booked with anesthesia service for the procedure.
Exclusion
- 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 as part of multimodal pain management
- 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)
Key Trial Info
Start Date :
November 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05283980
Start Date
November 17 2022
End Date
March 1 2025
Last Update
October 1 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
BIDMC
Boston, Massachusetts, United States, 02130