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Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

Primary Purpose

Post Operative Pain

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Continuous Infusion of ropivacaine
Intermittent bolus of ropivacaine
Sponsored by
Henry Ford Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henry Ford HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continuous Infusion

Intermittent Bolus

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

NRS Pain Scores (10)
Numeric rating scale for pain (rated 0=no pain through 10= worst imaginable pain)
ICU length of stay
Time from post-op to step-down from ICU
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)
Time to first antiemetic
Time to first antiemetic

Full Information

First Posted
November 30, 2022
Last Updated
March 10, 2023
Sponsor
Henry Ford Health System
Collaborators
Avanos Medical
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1. Study Identification

Unique Protocol Identification Number
NCT05642416
Brief Title
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
Official Title
Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
Collaborators
Avanos Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to one of two treatment groups (one with continuous infusion of drug and the other with bolus via ESP catheter)
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous Infusion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Intermittent Bolus
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Continuous Infusion of ropivacaine
Intervention Description
Continuous infusion of ropivacaine
Intervention Type
Drug
Intervention Name(s)
Intermittent bolus of ropivacaine
Intervention Description
Intermittent bolus of ropivacaine
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Opioid consumption (MME) over the course of the 72 hours following surgery
Time Frame
72 hours post-op
Secondary Outcome Measure Information:
Title
NRS Pain Scores (10)
Description
Numeric rating scale for pain (rated 0=no pain through 10= worst imaginable pain)
Time Frame
72 post-op
Title
ICU length of stay
Description
Time from post-op to step-down from ICU
Time Frame
72 hours post-op
Title
Quality of Recovery 15 (QoR-15) score
Description
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery)
Time Frame
72 hours post-op
Title
Time to first antiemetic
Description
Time to first antiemetic
Time Frame
72 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Katherine Nowak, PhD
Phone
313-771-7128
Email
knowak2@hfhs.org
Facility Information:
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Nowak, PhD
Phone
313-771-7128
Email
knowak2@hfhs.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not make individual participant data available to other researchers.

Learn more about this trial

Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT

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