Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

Last updated: April 9, 2025
Sponsor: Henry Ford Health System
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Continuous Infusion of ropivacaine

Intermittent bolus of ropivacaine

Clinical Study ID

NCT05642416
15737
  • Ages 18-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Non-emergent elective cardiac surgery requiring median sternotomy for surgicalexposure (i.e. CABG, aortic/mitral/tricuspid valve replacements) receiving ESPcatheter preoperatively

  • Age 18-90

Exclusion

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

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: Continuous Infusion of ropivacaine
Phase: 4
Study Start date:
October 15, 2022
Estimated Completion Date:
December 23, 2024

Study Description

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.

Connect with a study center

  • Henry Ford Hospital

    Detroit, Michigan 48201
    United States

    Site Not Available

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