Trial Outcomes & Findings for Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT (NCT NCT05642416)
NCT ID: NCT05642416
Last Updated: 2026-05-13
Results Overview
Opioid consumption (MME) over the course of the first 24 hours following surgery
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
240 participants
Primary outcome timeframe
0-24 hours post-op
Results posted on
2026-05-13
Participant Flow
Subjects were recruited from October 18th, 2022 through December 19th, 2024 from a large academic hospital in the midwestern United States.
All subjects who consented to participate in the study were randomized to one of the two groups.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Randomized
STARTED
|
119
|
121
|
|
Randomized
COMPLETED
|
119
|
121
|
|
Randomized
NOT COMPLETED
|
0
|
0
|
|
Allocation
STARTED
|
119
|
121
|
|
Allocation
COMPLETED
|
114
|
119
|
|
Allocation
NOT COMPLETED
|
5
|
2
|
|
Follow-Up
STARTED
|
114
|
119
|
|
Follow-Up
COMPLETED
|
97
|
110
|
|
Follow-Up
NOT COMPLETED
|
17
|
9
|
|
Analysis
STARTED
|
97
|
110
|
|
Analysis
COMPLETED
|
96
|
108
|
|
Analysis
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Allocation
Case cancelled
|
2
|
1
|
|
Allocation
Pump programming error
|
3
|
0
|
|
Allocation
Catheter not placed
|
0
|
1
|
|
Follow-Up
Not extubated in study period
|
8
|
3
|
|
Follow-Up
Repeat surgery during study period
|
4
|
1
|
|
Follow-Up
ESP catheter displaced/removed
|
3
|
3
|
|
Follow-Up
Physician Decision
|
1
|
0
|
|
Follow-Up
Insertion site pain
|
1
|
0
|
|
Follow-Up
Medication discontinued
|
0
|
1
|
|
Follow-Up
Withdrawal by Subject
|
0
|
1
|
|
Analysis
Pump programming error
|
1
|
1
|
|
Analysis
Treatment outside of protocol
|
0
|
1
|
Baseline Characteristics
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
Baseline characteristics by cohort
| Measure |
Continuous Infusion
n=96 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 Years
STANDARD_DEVIATION 29.5 • n=1512 Participants
|
64.2 Years
STANDARD_DEVIATION 29.2 • n=504 Participants
|
64.5 Years
STANDARD_DEVIATION 10.5 • n=2016 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=1512 Participants
|
30 Participants
n=504 Participants
|
55 Participants
n=2016 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=1512 Participants
|
78 Participants
n=504 Participants
|
149 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
3 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=1512 Participants
|
22 Participants
n=504 Participants
|
33 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=1512 Participants
|
73 Participants
n=504 Participants
|
151 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=1512 Participants
|
13 Participants
n=504 Participants
|
17 Participants
n=2016 Participants
|
|
Body Mass Index
|
29.5 kg/m^2
STANDARD_DEVIATION 5.2 • n=1512 Participants
|
29.2 kg/m^2
STANDARD_DEVIATION 5.8 • n=504 Participants
|
29.3 kg/m^2
STANDARD_DEVIATION 5.4 • n=2016 Participants
|
PRIMARY outcome
Timeframe: 0-24 hours post-opPopulation: Only subjects who completed the full duration of treatment were included (withdrawn patients were not included in the analysis).
Opioid consumption (MME) over the course of the first 24 hours following surgery
Outcome measures
| Measure |
Continuous Infusion
n=96 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
|---|---|---|
|
Opioid Consumption POD 1
|
86.6 MME
Standard Deviation 56.3
|
90.5 MME
Standard Deviation 55
|
PRIMARY outcome
Timeframe: 24-48 hours post-opPopulation: Only subjects who completed the full duration of treatment were included (withdrawn patients were not included in the analysis).
Opioid consumption (MME) over the course of the 48 hours following surgery
Outcome measures
| Measure |
Continuous Infusion
n=108 Participants
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.
|
Intermittent Bolus
n=96 Participants
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.
|
|---|---|---|
|
Opioid Consumption POD 2
|
40.0 MME
Standard Deviation 40.3
|
43.0 MME
Standard Deviation 41.2
|
PRIMARY outcome
Timeframe: 48-72 hours post-opPopulation: Only subjects who completed the full duration of treatment were included (withdrawn patients were not included in the analysis).
Opioid consumption (MME) over the course of the 48-72 hours following surgery
Outcome measures
| Measure |
Continuous Infusion
n=96 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
|---|---|---|
|
Opioid Consumption POD 3
|
18.8 MME
Standard Deviation 24
|
24.3 MME
Standard Deviation 30.4
|
SECONDARY outcome
Timeframe: 0-24 hrs post-opPopulation: Some participants in the continuous infusion arm were not able to provide NRS pain scores during their first 24 hours post-op.
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) in the first 24 hours post-op
Outcome measures
| Measure |
Continuous Infusion
n=92 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
|---|---|---|
|
NRS Pain Score POD 1
|
5.8 units on a scale
Standard Deviation 1.9
|
5.79 units on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 24-48 hrs post-opPopulation: One participant in the continuous infusion arm was not able to provide NRS pain scores on POD 2.
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) on POD 2
Outcome measures
| Measure |
Continuous Infusion
n=95 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
|---|---|---|
|
NRS Pain Score POD 2
|
5.8 units on a scale
Standard Deviation 1.9
|
4.55 units on a scale
Standard Deviation 1.68
|
SECONDARY outcome
Timeframe: 48-72 hrs post-opPopulation: One participant in the intermittent bolus arm was not able to provide NRS pain scores on POD 3.
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) during 48-72 hours post-op
Outcome measures
| Measure |
Continuous Infusion
n=96 Participants
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.
|
Intermittent Bolus
n=107 Participants
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.
|
|---|---|---|
|
NRS Pain Score POD 3
|
2.9 units on a scale
Standard Deviation 2.0
|
3.36 units on a scale
Standard Deviation 1.99
|
SECONDARY outcome
Timeframe: 7 days post-opTime from post-op to step-down from ICU
Outcome measures
| Measure |
Continuous Infusion
n=96 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
|---|---|---|
|
ICU Length of Stay
|
5.6 days
Standard Deviation 5.6
|
5.6 days
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: 0-24 hours post-opPopulation: Some subjects were unable to complete the QoR-15 on POD 1 because they remained intubated.
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 1.
Outcome measures
| Measure |
Continuous Infusion
n=65 Participants
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.
|
Intermittent Bolus
n=72 Participants
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.
|
|---|---|---|
|
Quality of Recovery 15 (QoR-15) Score POD 1
|
87 units on a scale
Standard Deviation 24
|
84 units on a scale
Standard Deviation 22
|
SECONDARY outcome
Timeframe: 24-48 hours post-opPopulation: Some subjects were unable to complete the QoR-15 on POD 2 because they remained intubated.
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 2.
Outcome measures
| Measure |
Continuous Infusion
n=70 Participants
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.
|
Intermittent Bolus
n=76 Participants
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.
|
|---|---|---|
|
Quality of Recovery 15 (QoR-15) Score POD 2
|
96 units on a scale
Standard Deviation 18
|
95 units on a scale
Standard Deviation 16
|
SECONDARY outcome
Timeframe: 48-72 hours post-opPopulation: Some subjects in both arms were unable to complete the QoR-15 on POD 3.
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 3.
Outcome measures
| Measure |
Continuous Infusion
n=84 Participants
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.
|
Intermittent Bolus
n=86 Participants
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.
|
|---|---|---|
|
Quality of Recovery 15 (QoR-15) Score POD 3
|
102 units on a scale
Standard Deviation 25
|
100 units on a scale
Standard Deviation 22
|
SECONDARY outcome
Timeframe: 0-200 hours post-opTime to first antiemetic post-op
Outcome measures
| Measure |
Continuous Infusion
n=96 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
|---|---|---|
|
Time to First Antiemetic
|
127 hours
Standard Deviation 159
|
134 hours
Standard Deviation 213
|
SECONDARY outcome
Timeframe: 0-72 hours post-opTime to first bowel movement post-op
Outcome measures
| Measure |
Continuous Infusion
n=96 Participants
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.
|
Intermittent Bolus
n=108 Participants
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.
|
|---|---|---|
|
Time to First Bowel Movement
|
29 hours
Standard Deviation 22
|
35 hours
Standard Deviation 30
|
Adverse Events
Continuous Infusion
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intermittent Bolus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place