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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a nerve block with bupivacaine, a local anesthetic, can reduce pain during heart device placement. The study compares bupivacaine to a saltwater solution to determine which provides better pain relief. It seeks participants scheduled for cardiac device implantation who will receive anesthesia for the procedure. Certain heart conditions or specific medications may disqualify potential participants. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like SSRIs, TCAs, anti-epileptics, gabapentin, or pregabalin for pain management.

What prior data suggests that pectoral nerve blocks with bupivacaine are safe for device placement?

Research shows that bupivacaine, when used in pectoral nerve blocks, is generally well-tolerated. Studies have found that these nerve blocks effectively reduce pain. For instance, one study found that using bupivacaine in PECS-II blocks lowered pain scores and reduced the need for opioids for up to 24 hours.

In this trial, the bupivacaine concentration is 0.25%, which past research typically considers safe. However, like any treatment, some individuals might experience side effects, such as numbness or tingling at the application site.

The advanced stage of this trial indicates that earlier studies have not raised major safety concerns, suggesting the treatment is likely safe for most participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about pectoral nerve blocks using 0.25% bupivacaine because this approach offers targeted pain relief for device placement procedures. Unlike typical systemic pain management options, like oral analgesics or traditional anesthesia, this method involves a localized injection that directly numbs the nerves in the chest area. This targeted delivery could lead to more effective pain control with potentially fewer systemic side effects. Additionally, by using bupivacaine, which is known for its long-acting properties, the procedure might provide extended pain relief, making recovery smoother and more comfortable for patients.

What evidence suggests that pectoral nerve blocks with bupivacaine are effective for analgesia during device placement?

Research has shown that using a small amount (0.25%) of bupivacaine for numbing certain nerves can effectively reduce pain. One study demonstrated that this method lowered pain levels during breast surgeries and reduced the need for painkillers like tramadol. Another study found that using bupivacaine in a specific nerve block (called PECS II) lowered pain and the use of painkillers for up to 24 hours after surgery. In this trial, participants in the Bupivacaine Group will receive up to 25 ml of 0.25% bupivacaine hydrochloride for the Pecs block, which is expected to provide effective pain relief during procedures like placing heart devices. ^{2 3 5 6 7}

Who Is on the Research Team?

Sankalp Sehgal, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6020587/

Efficacy of Pectoral Nerve Block using Bupivacaine with or ... Pedrosa in his study showed that the PECS block is an effective analgesic technique for breast reconstructive surgery and allows reduction of opioid (tramadol) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03731221

Pectoral Fascial Plane and Serratus Anterior Plane Blocks ... Control patients will have preservative free normal saline mixed with 0.5% bupivacaine HCL and all patients will have a total block solution volume of 60 ml.

3. link.springer.com link.springer.com/article/10.1007/s00266-025-04865-1

The Comparison of Efficacy of Bilateral Type I Versus ... PECS blocks could effectively reduce postoperative pain level in gynecomastia operations; however, PECS II block was superior to PECS I block in terms of both ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1053077022004438

Bilateral PECS II Block is Associated with Decreased ... PECS-II blocks were associated with modest decreases in pain scores at rest for up to 12 hours, and with reduced opioid consumption for up to 24 hours, ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/9/e101171

protocol for a randomised controlled trial This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle plane (TTP) block ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12496121/

Effect of liposomal bupivacaine combined with ... This study will investigate the analgesic efficacy of LB in combination with bupivacaine hydrochloride (BHCl) for transversus thoracic muscle ...

7. withpower.com withpower.com/trial/phase-2-and-3-chest-pain-3-2022-58f98

Pectoral Nerve Blocks with Bupivacaine for Device ... 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 ...