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ESP/PIF for Sternotomy

NCT04985500 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2025-07-15

No results posted yet for this 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.

Conditions

  • Cardiac Surgery
  • Sternotomy

Interventions

PROCEDURE

ESP block

peripheral nerve block

PROCEDURE

PIF block

peripheral nerve block

PROCEDURE

Ultrasound

Ultrasound guidance

DRUG

Bupivacain

10-20 mL of 0.25% bupivacaine

Sponsors & Collaborators

Principal Investigators

  • Ali Shariat, M.D. · Mount Sinai West and Morningside Hospitals

  • Himani Bhatt, D.O. · Mount Sinai West and Morningside Hospitals

  • Shenghao Fang, M.D. · Mount Sinai West and Morningside Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-09
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04985500 on ClinicalTrials.gov