Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

Phase 4

Completed

• Conditions: Post Operative Pain
• Interventions: Drug: Continuous Infusion of ropivacaine; Drug: Intermittent bolus of ropivacaine

• Registration Number: NCT05642416
• Lead Sponsor: Henry Ford Health System

Brief 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.

Study Timeline

• Study Start: 2022-10-15
• Study First Submitted: 2022-11-30
• Study First Submitted QC: 2022-11-30
• Study First Posted: 2022-12-08
• Status Verified: 2024-04
• Primary Completion: 2024-12-23
• Study Completion: 2024-12-23
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Infusion	Continuous Infusion of ropivacaine	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.
Intermittent Bolus	Intermittent bolus of ropivacaine	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.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	72 hours post-op	Opioid consumption (MME) over the course of the 72 hours following surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States