ESP/PIF for Sternotomy

NCT04985500 | Active Not Recruiting Early Phase 1 FDA Drug

• 1 other identifier: STUDY-20-01473
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ESP Block; PIF Block; Cardiac Surgery; Sternotomy

Outcome Measures

Primary Outcomes (3)

• Opioid Consumption during first 24 hours post-op

  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

  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

  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 Outcomes (3)

• Visual Analogue Score (VAS) Pain Score post-op 24 hours

  Post-operative 24 hours

• Visual Analogue Score (VAS) Pain Score post-op 48 hours

  Post-operative 48 hours

• Visual Analogue Score (VAS) Pain Score post-op 72 hours

  Post-operative 72 hours

Study Arms (3)

ESP group

EXPERIMENTAL

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; Procedure: Ultrasound; Drug: Bupivacain

PIF group

EXPERIMENTAL

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: PIF block; Procedure: Ultrasound; Drug: Bupivacain

No Block group

NO INTERVENTION

Patient will not receive block.

Interventions

ESP block PROCEDURE

peripheral nerve block

Also known as: erector spinal plane block

ESP group

PIF block PROCEDURE

peripheral nerve block

Also known as: pecto-intercostal fascial plane block

PIF group

Ultrasound PROCEDURE

Ultrasound guidance

ESP group; PIF group

Bupivacain DRUG

10-20 mL of 0.25% bupivacaine

ESP group; PIF group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Morningside Hospital

New York, New York, 10025, United States

Location

MeSH Terms

Interventions

High-Energy Shock Waves; Bupivacaine

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ali Shariat, M.D.

  Mount Sinai West and Morningside Hospitals

  PRINCIPAL INVESTIGATOR

• Himani Bhatt, D.O.

  Mount Sinai West and Morningside Hospitals

  STUDY DIRECTOR

• Shenghao Fang, M.D.

  Mount Sinai West and Morningside Hospitals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The anesthesiologist assessing the patient will be blinded
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1) ESP group, 2) PIF group, or 3) no block group.

Study Record Dates

• First Submitted: July 6, 2021
• First Posted: August 2, 2021
• Study Start: July 9, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)