Can a simple nerve block replace opioids after heart device surgery?

NCT ID NCT05283980

Symptom relief Sponsor: Beth Israel Deaconess Medical Center Source: ClinicalTrials.gov ↗

First seen Jul 30, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This trial tests whether a pectoral nerve block using the anesthetic bupivacaine can reduce pain and opioid use in adults receiving a cardiac implantable electronic device (CIED). Participants are randomly assigned to receive either the nerve block or a placebo injection. The study measures opioid consumption and pain scores over the first 24 hours after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: a pectoral nerve block using the anesthetic bupivacaine
What this could lead to: If it works, this could offer a way to manage pain after cardiac device surgery with fewer opioids.
What could go wrong: This is a small pilot study, so results may not apply broadly. The nerve block carries rare risks like infection or bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

62 people

The number who actually took part.

Started

Nov 2022

Finished

Mar 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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)

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Conditions

The condition(s) this trial relates to.

Acute Pain Chest Pain opioid abuse Pain Pain, Postoperative Patient Satisfaction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid use, unspecified Opioids; harmful use Pain Pain, acute Pain, chest Pain, postoperative Satisfaction, patient

Can a simple nerve block replace opioids after heart device surgery?

What the study statuses mean