ESP/PIF for Sternotomy

Last updated: July 3, 2024
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Not Recruiting

Phase

1

Condition

Cardiac Surgery

Treatment

Bupivacain

PIF block

Ultrasound

Clinical Study ID

NCT04985500
STUDY-20-01473
  • Ages 18-85
  • All Genders

Study Summary

This is a randomized study. The purpose of this study is to evaluate the effect of post-surgical pain control of two types of peripheral nerve blocks, specifically erector spinal plane (ESP) block and pecto-intercostal fascial (PIF) plane block.

90 subjects, from 18-85 years of age, undergoing cardiac surgery with median sternal incision will be enrolled at Mount Sinai Morningside Hospital Center. Study participation will last from the time of pre-operative evaluation to 72 hours after surgery. Subjects will be randomly assigned to receive 1 of the 3 different regimens at the beginning of surgery. Opioid consumption and pain scores after surgery will be evaluated. Though unlikely, risks include systemic absorption of local anesthetic, which can result in both central nervous system and cardiac toxicity.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults 18-85 years old

  • Scheduled to undergo cardiac procedures involving sternotomy

  • All genders

Exclusion

Exclusion Criteria:

  • ASA class V

  • Urgent or emergent surgery

  • Contraindications to administration of local anesthesia (e.g. local anestheticallergy)

  • History of substance abuse or chronic opioid use

  • Patient refusal or inability to consent

Study Design

Total Participants: 225
Treatment Group(s): 4
Primary Treatment: Bupivacain
Phase: 1
Study Start date:
July 09, 2021
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Mount Sinai Morningside Hospital

    New York, New York 10025
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.