ESP/PIF for Sternotomy

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985500
• Other study ID #: STUDY-20-01473
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 8, 2021
• Est. completion date: August 2024

Study information

• Verified date: April 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Shenghao Fang, M.D.
• Phone: 434-326-8499
• Email: shenghao.fang[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery
• Sternotomy

Intervention

Procedure:
• ESP block
peripheral nerve block
• PIF block
peripheral nerve block
• Ultrasound
Ultrasound guidance

Drug:
• Bupivacain
10-20 mL of 0.25% bupivacaine

Locations

Country	Name	City	State
United States	Mount Sinai Morningside Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Visual Analogue Score (VAS) Pain Score post-op 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
Secondary	Visual Analogue Score (VAS) Pain Score post-op 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
Secondary	Visual Analogue Score (VAS) Pain Score post-op 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