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Can a Two-Drug anesthetic mix ease pain and cut narcotic use after heart device surgery?

NCT ID NCT01300377

Symptom relief Sponsor: Baylor Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time

Summary

This trial compares two standard local anesthetics given during pacemaker or defibrillator surgery: a mixture of lidocaine and bupivacaine versus lidocaine alone. Researchers want to see if the mixture reduces postoperative pain and the need for narcotic painkillers. About 350 people having arrhythmia surgery at Baylor Heart and Vascular Institute will take part. Neither the patients nor the doctors will know which treatment each person receives.

What this could mean

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

Active substance
A local anesthetic mixture of lidocaine and bupivacaine, compared with lidocaine alone, injected at the surgical site during pacemaker or defibrillator implantation.
What this could lead to
If the mixture works better, it could point to a standard way to ease pain and cut narcotic use after pacemaker or defibrillator surgery.
What could go wrong
This is an early, single-center trial with no control group, so results may not apply broadly. The pain relief difference may be small, and any benefit must be weighed against the risks of local anesthetics.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

350 people

The number who actually took part.

Start date

Nov 2008

Finished

Dec 2018

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

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Arrythmia patients receiving pacemaker or cardiac defibrillator devices at Baylor Heart and Vascular Institute. Exclusion Criteria: * Receiving complicated procedures * Replacement of parts, not inclusive of leads

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Conditions

The condition(s) this trial relates to.

cardiac rhythm disease Pain Pain, Postoperative

As listed by the trial registrant

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

Post operative pain

Contacts and locations

Locations

  • Baylor Jack and Jane Heart and Vascular Institute

    Dallas, Texas, 75226, United States

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