Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henry Ford Health System
• Collaborator: Avanos Medical
• Treatments: Ropivacaine

Criteria

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