ESP/PIF for Sternotomy

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT04985500

Collaborator

(none)

Enrollment

Location

Arms

12.8

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Sternotomy	Procedure: ESP block Procedure: PIF block Procedure: Ultrasound Drug: Bupivacain	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Intervention Model Description:

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.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.

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The anesthesiologist assessing the patient will be blinded

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 8, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ESP group 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 peripheral nerve block Other Names: erector spinal plane block Procedure: Ultrasound Ultrasound guidance Drug: Bupivacain 10-20 mL of 0.25% bupivacaine
Experimental: PIF group 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 peripheral nerve block Other Names: pecto-intercostal fascial plane block Procedure: Ultrasound Ultrasound guidance Drug: Bupivacain 10-20 mL of 0.25% bupivacaine
No Intervention: No Block group Patient will not receive block.

Arm

Intervention/Treatment

Experimental: ESP group

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

peripheral nerve block

Other Names:

erector spinal plane block

Procedure: Ultrasound

Ultrasound guidance

Drug: Bupivacain

10-20 mL of 0.25% bupivacaine

Experimental: PIF group

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

peripheral nerve block

Other Names:

pecto-intercostal fascial plane block

Procedure: Ultrasound

Ultrasound guidance

Drug: Bupivacain

10-20 mL of 0.25% bupivacaine

No Intervention: No Block group

Patient will not receive block.

Outcome Measures

Primary Outcome Measures

Opioid Consumption during first 24 hours post-op [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.
Opioid Consumption during first 48 hours post-op [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.
Opioid Consumption during first 72 hours post-op [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 Outcome Measures

Visual Analogue Score (VAS) Pain Score post-op 24 hours [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.
Visual Analogue Score (VAS) Pain Score post-op 48 hours [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.
Visual Analogue Score (VAS) Pain Score post-op 72 hours [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai Morningside Hospital	New York	New York	United States	10025

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Ali Shariat, M.D., Mount Sinai West and Morningside Hospitals
Study Director: Himani Bhatt, D.O., Mount Sinai West and Morningside Hospitals
Study Director: Shenghao Fang, M.D., Mount Sinai West and Morningside Hospitals