ESP/PIF for Sternotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-09

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cardiac Surgery Sternotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

The anesthesiologist assessing the patient will be blinded

Study Groups

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ESP group

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No