Pectoral Nerve Blocks with Bupivacaine for Device Placement

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: SSRIs, TCAs, Anti-epileptics, others

Disqualifiers: Chronic opioid use, Hypersensitivity, Hemodynamics, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 1 day

62 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Sankalp Sehgal, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for adults over 18 who are scheduled to receive a cardiac implantable electronic device (CIED) and will have anesthesia during the procedure. It's not for those in other studies, needing urgent procedures, using certain pain or psychiatric meds, with chronic opioid use, allergic to bupivacaine, or having unstable vital signs.

Inclusion Criteria

Undergoing CIED placement in electrophysiology lab

Booked with anesthesia service for the procedure

Exclusion Criteria

Current participation in another interventional study

Emergent procedures

You are using other types of regional anesthesia, such as intrathecal morphine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a Pecs block with 0.25% bupivacaine or a placebo for analgesia during CIED placement

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain scores and opioid consumption at 1 hour, 12 hours, and 24 hours post-procedure

1 day

3 visits (in-person)

Treatment Details

Interventions

• 0.25% Bupivacaine

Trial Overview The study tests if pectoral nerve blocks using 0.25% bupivacaine provide better pain relief than placebo during CIED placement in the heart electrophysiology lab. The goal is to see if this can reduce postoperative pain and improve patient satisfaction without opioids.

Participant Groups

Group I: Bupivacaine Group Experimental Treatment 1 Intervention

Receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block

Group II: Control group Placebo Group 1 Intervention

Receive up to 25 ml of normal 0.9% sodium chloride for the Pecs block

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+