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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05283980
Recruitment Status : Not yet recruiting
First Posted : March 17, 2022
Last Update Posted : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Sankalp Sehgal, Beth Israel Deaconess Medical Center

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 cardiac implantable electronic device (CIED) placement in cardiac electrophysiology lab

Condition or disease Intervention/treatment Phase
Pain, Postoperative Pain, Acute Pain, Chest Pain Satisfaction, Patient Opioid Use, Unspecified Opioids; Harmful Use Drug: 0.25% Bupivacaine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is prospective, randomized, triple-blinded placebo-controlled study. Subjects will be randomize to undergo PECs block in the pre-procdure/ pre-operative area with either ).25% bupivacaine or 0.9% normal saline. They will then undergo the CIED placement in electrophysiology lab as current standard of care.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Enrolled subjects will be randomized to one of the two study groups, in a 1:1 randomization ratio. Patients randomized to Group 1, or the bupivacaine group, will receive up to 25cc of 0.25% bupivacaine hydrochloride for the PECs blocks. In Group 2, patients will receive up to 25cc of normal saline. Use of placebo is a standard control procedure in clinical trials and will allow for the assessment of unbiased quantitative data on the efficacy across all treatment groups.
Primary Purpose: Prevention
Official Title: Pectoral Nerve Blocks (PECs) for Cardiovascular Implantable Electronic Device Placement: A Pilot Study
Estimated Study Start Date : April 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : August 2023


Arm Intervention/treatment
Experimental: Bupivacaine Group
Receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block
Drug: 0.25% Bupivacaine
The intervention group/ bupivacaine group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block in comparison to the control group that would receive 0.9% normal saline

Placebo Comparator: Control group
Receive up to 25 ml of normal 0.9% sodium chloride for the Pecs block
Drug: 0.25% Bupivacaine
The intervention group/ bupivacaine group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block in comparison to the control group that would receive 0.9% normal saline




Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 24 hours peri-procedure ]
    peri-operative 24-hour consumption of opioids measured as OMEs (Opioid milliequivalents) in patients undergoing CIED procedures with and without Pecs blocks


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: at 1hr, 12hr and 24hr ]
    measure patient pain scores at 1hr, 12hr and 24hr after CIED procedure completion

  2. Patient satisfaction scores [ Time Frame: at 24 hours post-procedure ]
    compare patient satisfaction scores at 24 hours between the two study groups and report the incidence of overall complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05283980


Locations
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United States, Massachusetts
BIDMC
Boston, Massachusetts, United States, 02130
Contact: Sankalp Sehgal    501-615-5352    sehgal_sankalp@yahoo.com   
Contact       sehgal_sankalp@yahoo.com   
Principal Investigator: Sankalp Sehgal, MD         
Sub-Investigator: Balachundhar Subramaniam, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Responsible Party: Sankalp Sehgal, MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT05283980    
Other Study ID Numbers: BIDMC
First Posted: March 17, 2022    Key Record Dates
Last Update Posted: March 17, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pain, Postoperative
Acute Pain
Chest Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents