← Back to Search

Pectoral Nerve Blocks with Bupivacaine for Device Placement

Phase 2 & 3
Waitlist Available
Led By Sankalp Sehgal, MD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 hour, 12 hour and 24hours
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved

Summary

This trial will compare the effectiveness of a local anesthetic to a placebo for pain relief during a medical procedure.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of bupivacaine include discomfort at injection site, weakness or numbness near the chest area where it's injected, low blood pressure, dizziness, nausea or vomiting. Severe reactions might be an allergic response or trouble breathing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 hour, 12 hour and 24hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 hour, 12 hour and 24hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Opioid consumption
Secondary study objectives
Pain scores on a scale 1 - 10, 1 being the least pain and 10 being the worst pain
Patient satisfaction scores

Awards & Highlights

Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bupivacaine GroupExperimental Treatment1 Intervention
Receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block
Group II: Control groupPlacebo Group1 Intervention
Receive up to 25 ml of normal 0.9% sodium chloride for the Pecs block
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bupivacaine
FDA approved

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
855 Previous Clinical Trials
12,930,732 Total Patients Enrolled
10 Trials studying Pain
5,859 Patients Enrolled for Pain
Sankalp Sehgal, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center
~5 spots leftby Mar 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top