ESP/PIF for Sternotomy

Study Overview
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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.

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

Conditions
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Cardiac Surgery, Sternotomy

Intervention / Treatment
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* Procedure: ESP block
* Procedure: PIF block
* Procedure: Ultrasound
* Drug: Bupivacain


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESP group<br>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<br>* peripheral nerve block<br>* Other names: erector spinal plane block;Procedure: Ultrasound<br>* Ultrasound guidance<br>Drug: Bupivacain<br>* 10-20 mL of 0.25% bupivacaine<br>|
| Experimental: PIF group<br>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<br>* peripheral nerve block<br>* Other names: pecto-intercostal fascial plane block;Procedure: Ultrasound<br>* Ultrasound guidance<br>Drug: Bupivacain<br>* 10-20 mL of 0.25% bupivacaine<br>|
| No Intervention: No Block group<br>Patient will not receive block. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ESP Block, PIF Block, Cardiac Surgery, Sternotomy