ESP/PIF for Sternotomy

July 10, 2025 updated by: Ali Nima Shariat, Icahn School of Medicine at Mount Sinai

Erector Spinae Plane Block vs. Pecto-intercostal Fascial Plane Block vs. Control for Sternotomy: A Prospective Randomized Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

225

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10025
        • Mount Sinai Morningside Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18-85 years old
  • Scheduled to undergo cardiac procedures involving sternotomy
  • All genders

Exclusion Criteria:

  • ASA class V
  • Urgent or emergent surgery
  • Contraindications to administration of local anesthesia (e.g. local anesthetic allergy)
  • History of substance abuse or chronic opioid use
  • Patient refusal or inability to consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESP group
Patient will receive ESP block with ultrasound guidance the transverse process of the vertebra at T7 is visualized and 20 mL of 0.25% bupivacaine will be injected between the transverse process and the erector spinae muscle on each side using a 21-gauge block needle.
Procedure: ESP block
peripheral nerve block
Other Names:
  • erector spinal plane block
Procedure: Ultrasound
Ultrasound guidance
Drug: Bupivacain
10-20 mL of 0.25% bupivacaine
Experimental: PIF group
Patient will receive PIF block after intubation with ultrasound placed 1-2 cm lateral to the sternal border and the pectoralis major and external intercostal muscles are visualized at the level of ribs 3-4 where 10 mL of 0.25% bupivacaine will be injected on each side using a 21-gauge block needle.
Procedure: Ultrasound
Ultrasound guidance
Drug: Bupivacain
10-20 mL of 0.25% bupivacaine
Procedure: PIF block
peripheral nerve block
Other Names:
  • pecto-intercostal fascial plane block
No Intervention: No Block group
Patient will not receive block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid Consumption during first 24 hours post-op
Time Frame: Post-operative 24 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Post-operative 24 hours
Opioid Consumption during first 48 hours post-op
Time Frame: Post-operative 48 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Post-operative 48 hours
Opioid Consumption during first 72 hours post-op
Time Frame: Post-operative 72 hours
The amount of opioid consumption (in mg IV morphine equivalents) during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Post-operative 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Score (VAS) Pain Score post-op 24 hours
Time Frame: Post-operative 24 hours
VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 24 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Post-operative 24 hours
Visual Analogue Score (VAS) Pain Score post-op 48 hours
Time Frame: Post-operative 48 hours
VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 48 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Post-operative 48 hours
Visual Analogue Score (VAS) Pain Score post-op 72 hours
Time Frame: Post-operative 72 hours
VAS Pain Score from 0-10, with higher score indicating more pain. The average VAS pain scores during the first 72 hours post-op in patients undergoing cardiac surgeries with median sternotomy.
Post-operative 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Ali Shariat, M.D., Mount Sinai West and Morningside Hospitals
  • Study Director: Himani Bhatt, D.O., Mount Sinai West and Morningside Hospitals
  • Study Director: Shenghao Fang, M.D., Mount Sinai West and Morningside Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2021

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 22, 2021

First Posted (Actual)

August 2, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2025

Last Update Submitted That Met QC Criteria

July 10, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY-20-01473

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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