ESP/PIF for Sternotomy

Early Phase 1Active Not RecruitingNCT04985500

Icahn School of Medicine at Mount Sinai225 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

225

Conditions

Cardiac Surgery Sternotomy

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Post-operative 72 hours

Secondary Outcomes

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.

Time frame: Post-operative 24 hours

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.