Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Henry Ford Health System
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Opioid Consumption POD 1
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes 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.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Continuous Infusion
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.
Intervention: Continuous Infusion of ropivacaine (Drug)
Intermittent Bolus
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: Intermittent bolus of ropivacaine (Drug)
Outcomes
Primary Outcomes
Opioid Consumption POD 1
Time Frame: 0-24 hours post-op
Opioid consumption (MME) over the course of the first 24 hours following surgery
Opioid Consumption POD 2
Time Frame: 24-48 hours post-op
Opioid consumption (MME) over the course of the 48 hours following surgery
Opioid Consumption POD 3
Time Frame: 48-72 hours post-op
Opioid consumption (MME) over the course of the 48-72 hours following surgery
Secondary Outcomes
- Quality of Recovery 15 (QoR-15) Score POD 2(24-48 hours post-op)
- NRS Pain Score POD 1(0-24 hrs post-op)
- NRS Pain Score POD 2(24-48 hrs post-op)
- NRS Pain Score POD 3(48-72 hrs post-op)
- ICU Length of Stay(7 days post-op)
- Quality of Recovery 15 (QoR-15) Score POD 1(0-24 hours post-op)
- Quality of Recovery 15 (QoR-15) Score POD 3(48-72 hours post-op)
- Time to First Antiemetic(0-200 hours post-op)
- Time to First Bowel Movement(0-72 hours post-op)
Investigators
Patrick Forrest
Principal Investigator
Henry Ford Health System