Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

NCT05642416 | Completed Phase 4 FDA Drug

• 1 other identifier: 15737
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

  Opioid consumption (MME) over the course of the 72 hours following surgery

  72 hours post-op

Secondary Outcomes (4)

• NRS Pain Scores (10)

  72 post-op

• ICU length of stay

  72 hours post-op

• Quality of Recovery 15 (QoR-15) score

  72 hours post-op

• Time to first antiemetic

  72 hours post-op

Study Arms (2)

Continuous Infusion

ACTIVE COMPARATOR

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.

Drug: Continuous Infusion of ropivacaine

Intermittent Bolus

EXPERIMENTAL

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.

Drug: Intermittent bolus of ropivacaine

Interventions

Continuous Infusion of ropivacaine DRUG

Continuous infusion of ropivacaine

Continuous Infusion

Intermittent bolus of ropivacaine DRUG

Intermittent bolus of ropivacaine

Intermittent Bolus

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Henry Ford Health System: lead
• Avanos Medical: collaborator

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The only people who will know the treatment arm that has been assigned to the participant are the research coordinator who randomized them and the regional anesthesia team. The patient, nursing team, and research coordinator performing outcomes assessments will all be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients will be randomized to one of two treatment groups (one with continuous infusion of drug and the other with bolus via ESP catheter)

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 8, 2022
• Study Start: October 15, 2022
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: April 11, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)