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Active, Not Recruiting

NCT Number: NCT04985500

ESP/PIF for Sternotomy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cardiac Surgery Sternotomy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mount Sinai Morningside Hospital

New York, 10025, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ESP block

Procedure

peripheral nerve block

Other names: erector spinal plane block

PIF block

Procedure

peripheral nerve block

Other names: pecto-intercostal fascial plane block

Ultrasound

Procedure

Ultrasound guidance

Bupivacain

Drug

10-20 mL of 0.25% bupivacaine

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2021
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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