NCT05642416

Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Post Operative Pain

Interventions

Type	Name	Description
DRUG	Continuous Infusion of ropivacaine	Continuous infusion of ropivacaine
DRUG	Intermittent bolus of ropivacaine	Intermittent bolus of ropivacaine

Timeline

• Start date: 2022-10-15
• Primary completion: 2024-12-23
• Completion: 2024-12-23
• First posted: 2022-12-08
• Last updated: 2025-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study