Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

Study Overview
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Brief Summary
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The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.

Detailed Description
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The purpose of this prospective randomized controlled trial is to compare the effectiveness of two different delivery methods for postoperative pain management following cardiac surgery requiring median sternotomy: intermittent programmed LA bolus versus continuous LA infusion through ESP catheters. Effectiveness of analgesia will be assessed based on the subjects' NRS pain scores and opioid consumption. The primary outcome measure will be the patients' opioid consumption over the course of the 72 hours following surgery. Secondary outcomes measures that will be evaluated include NRS pain scores, intensive care unit (ICU) length of stay, and time to first dose of antiemetic in the postoperative period. It is hypothesized that the use of intermittent programmed LA boluses will provide better analgesia compared to continuous LA infusion through ESP catheters. The findings of this study will provide guidance regarding the optimal method of delivery for postoperative pain management in patients following cardiac surgery.

Official Title
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Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Continuous Infusion of ropivacaine
* Drug: Intermittent bolus of ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-emergent elective cardiac surgery requiring median sternotomy for surgical exposure (i.e. CABG, aortic/mitral/tricuspid valve replacements) receiving ESP catheter preoperatively Age 18-90 Exclusion Criteria: Placement and/or existence of cardiac assist devices (LVAD, RVAD, Balloon Pump, Impella) Neurocognitive dysfunction Patients who expire before extubation Non-English speaking Daily opioid therapy prior to surgery History of substance abuse BMI > 45

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Parallel Assignment
Interventional Model Description: Patients will be randomized to one of two treatment groups (one with continuous infusion of drug and the other with bolus via ESP catheter)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Infusion<br>Will receive a continuous infusion of pain medication (0.2% ropivacaine at a rate of 10mL per hour- 5mL per side per hour) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. | Drug: Continuous Infusion of ropivacaine<br>* Continuous infusion of ropivacaine<br>|
| Experimental: Intermittent Bolus<br>Will receive intermittent boluses of pain medication (30mL bolus of 0.2% ropivacaine every three hours) via erector spinae plane (ESP) catheter for their postoperative pain following median sternotomy incision. | Drug: Intermittent bolus of ropivacaine<br>* Intermittent bolus of ropivacaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Opioid consumption (MME) over the course of the 72 hours following surgery | 72 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS Pain Scores (10) | Numeric rating scale for pain (rated 0=no pain through 10= worst imaginable pain) | 72 post-op | 
| ICU length of stay | Time from post-op to step-down from ICU | 72 hours post-op | 
| Quality of Recovery 15 (QoR-15) score | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) | 72 hours post-op | 
| Time to first antiemetic | Time to first antiemetic | 72 hours post-op |