NCT04985500

ESP/PIF for Sternotomy

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

• Status: Active Not Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2021-07-09
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-08-02
• Last updated: 2025-07-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study