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Pecto-intercostal fascial block for Autonomic Nerve Block

N/A

Recruiting

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

American Society of Anesthesiologists (ASA) physical status I-IV

Undergoing primary cardiac surgery requiring sternotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 hours after block procedure

Awards & highlights

Study Summary

This trial is studying the use of a nerve block with a local anesthetic to see if it improves pain control after surgery. Participants will be randomly assigned to receive either the nerve block or a saline solution

Who is the study for?

This trial is for individuals undergoing open heart surgery, who can have their medical history and medication use reviewed. They must be able to receive a nerve block in addition to standard pain control methods. There's no information on who cannot participate provided here.Check my eligibility

What is being tested?

The study tests if adding a bilateral nerve block with ropivacaine (a local anesthetic) improves pain management after open heart surgery compared to using saline solution, alongside regular pain relief measures.See study design

What are the potential side effects?

Possible side effects of the Pecto-Intercostal Fascial Block may include discomfort at the injection site, potential numbness or weakness in the chest wall, and rare complications related to nerve blocks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My health is classified between ASA I and IV.

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I am scheduled for heart surgery that involves opening my chest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours after block procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 hours after block procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours after block procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence nausea and/or vomiting after surgery

NRS pain score at 48 hours

OPIOID consumption at 24 hours

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Pecto-intercostal fascial blockActive Control1 Intervention

Pecto-intercostal Fascial Block with 20 ml of 0.35% ropivacaine injected to each side under ultrasound visualization.

Group II: PlaceboPlacebo Group1 Intervention

Pecto-intercostal Fascial Block with 20ml of normal saline injected to each side under ultrasound visualization.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,536 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research study currently accepting new participants?

"Indeed, as per the information available on clinicaltrials.gov, this research study is actively seeking eligible participants. The trial was originally posted on October 16th, 2023 and was last updated on January 22nd, 2024. There is a requirement to enroll a total of 84 individuals across one designated site."

Answered by AI

What is the current number of individuals actively engaged in this clinical investigation?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking eligible candidates. The initial posting date was recorded as October 16, 2023, and the most recent update occurred on January 22, 2024. In order to complete the study successfully, a total of 84 participants are being sought from a single designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sternotomy PIFB Block in Open Heart Surgery

Erica Stein 2023. "Sternotomy PIFB Block in Open Heart Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06233318.