Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05642416
• Other study ID #: 15737
• Status: Recruiting
• Phase: Phase 4
• Start date: October 15, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: April 2024
• Source: Henry Ford Health System
• Contact: Katherine Nowak, PhD
• Phone: 313-771-7128
• Email: knowak2[@]hfhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Continuous Infusion of ropivacaine
Continuous infusion of ropivacaine
• Intermittent bolus of ropivacaine
Intermittent bolus of ropivacaine

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Henry Ford Health System	Avanos Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption	Opioid consumption (MME) over the course of the 72 hours following surgery	72 hours post-op
Secondary	NRS Pain Scores (10)	Numeric rating scale for pain (rated 0=no pain through 10= worst imaginable pain)	72 post-op
Secondary	ICU length of stay	Time from post-op to step-down from ICU	72 hours post-op
Secondary	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
Secondary	Time to first antiemetic	Time to first antiemetic	72 hours post-op