Clinical trial NCT05642416: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Avanos Medical
First posted: 2022-12-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Opioid consumption
timeFrame: 72 hours post-op
Secondary outcomes:
measure: NRS Pain Scores (10)
timeFrame: 72 post-op
measure: ICU length of stay
timeFrame: 72 hours post-op
measure: Quality of Recovery 15 (QoR-15) score
timeFrame: 72 hours post-op
measure: Time to first antiemetic
timeFrame: 72 hours post-op
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
References: