Post Operative Pain
Conditions
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.
Interventions
DRUGContinuous Infusion of ropivacaine
Continuous infusion of ropivacaine
DRUGIntermittent bolus of ropivacaine
Intermittent bolus of ropivacaine
Sponsors
Henry Ford Health System
Avanos Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, 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.
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption POD 1 | 0-24 hours post-op | Opioid consumption (MME) over the course of the first 24 hours following surgery |
| Opioid Consumption POD 2 | 24-48 hours post-op | Opioid consumption (MME) over the course of the 48 hours following surgery |
| Opioid Consumption POD 3 | 48-72 hours post-op | Opioid consumption (MME) over the course of the 48-72 hours following surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain Score POD 1 | 0-24 hrs post-op | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) in the first 24 hours post-op |
| NRS Pain Score POD 2 | 24-48 hrs post-op | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) on POD 2 |
| NRS Pain Score POD 3 | 48-72 hrs post-op | Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) during 48-72 hours post-op |
| ICU Length of Stay | 7 days post-op | Time from post-op to step-down from ICU |
| Quality of Recovery 15 (QoR-15) Score POD 1 | 0-24 hours post-op | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 1. |
| Quality of Recovery 15 (QoR-15) Score POD 2 | 24-48 hours post-op | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 2. |
| Quality of Recovery 15 (QoR-15) Score POD 3 | 48-72 hours post-op | Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 3. |
| Time to First Antiemetic | 0-200 hours post-op | Time to first antiemetic post-op |
| Time to First Bowel Movement | 0-72 hours post-op | Time to first bowel movement post-op |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from October 18th, 2022 through December 19th, 2024 from a large academic hospital in the midwestern United States.
Pre-assignment details
All subjects who consented to participate in the study were randomized to one of the two groups.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 64.5 Years STANDARD_DEVIATION 10.5 |
| Body Mass Index | 29.2 kg/m^2 STANDARD_DEVIATION 5.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 17 Participants |
| Race (NIH/OMB) White | 151 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 108 |
| other Total, other adverse events | 0 / 96 | 0 / 108 |
| serious Total, serious adverse events | 0 / 96 | 0 / 108 |
Outcome results
None listed