A Phase 4 interventional study of Continuous Infusion of ropivacaine and Intermittent bolus of ropivacaine in Post Operative Pain, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment
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.
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 240 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
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Exclusion Criteria:
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.
Drug: Continuous Infusion of ropivacaine
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.
Drug: Intermittent bolus of ropivacaine
Continuous infusion of ropivacaine
Intermittent bolus of ropivacaine
Opioid Consumption POD 1
Opioid consumption (MME) over the course of the first 24 hours following surgery
Time frame: 0-24 hours post-op
Opioid Consumption POD 2
Opioid consumption (MME) over the course of the 48 hours following surgery
Time frame: 24-48 hours post-op
Opioid Consumption POD 3
Opioid consumption (MME) over the course of the 48-72 hours following surgery
Time frame: 48-72 hours post-op
NRS Pain Score POD 1
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) in the first 24 hours post-op
Time frame: 0-24 hrs post-op
NRS Pain Score POD 2
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) on POD 2
Time frame: 24-48 hrs post-op
NRS Pain Score POD 3
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) during 48-72 hours post-op
Time frame: 48-72 hrs post-op
ICU Length of Stay
Time from post-op to step-down from ICU
Time frame: 7 days post-op
Quality of Recovery 15 (QoR-15) Score POD 1
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 1.
Time frame: 0-24 hours post-op
Quality of Recovery 15 (QoR-15) Score POD 2
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 2.
Time frame: 24-48 hours post-op
Quality of Recovery 15 (QoR-15) Score POD 3
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 3.
Time frame: 48-72 hours post-op
Time to First Antiemetic
Time to first antiemetic post-op
Time frame: 0-200 hours post-op
Time to First Bowel Movement
Time to first bowel movement post-op
Time frame: 0-72 hours post-op
Subjects were recruited from October 18th, 2022 through December 19th, 2024 from a large academic hospital in the midwestern United States.
| Milestone | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Started | 119 | 121 |
| Completed | 119 | 121 |
| Not completed | 0 | 0 |
| Milestone | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Started | 119 | 121 |
| Completed | 114 | 119 |
| Not completed | 5 | 2 |
| Withdrew: Case cancelled | 2 | 1 |
| Withdrew: Pump programming error | 3 | 0 |
| Withdrew: Catheter not placed | 0 | 1 |
| Milestone | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Started | 114 | 119 |
| Completed | 97 | 110 |
| Not completed | 17 | 9 |
| Withdrew: Not extubated in study period | 8 | 3 |
| Withdrew: Repeat surgery during study period | 4 | 1 |
| Withdrew: Esp catheter displaced/removed | 3 | 3 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Insertion site pain | 1 | 0 |
| Withdrew: Medication discontinued | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Milestone | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Started | 97 | 110 |
| Completed | 96 | 108 |
| Not completed | 1 | 2 |
| Withdrew: Pump programming error | 1 | 1 |
| Withdrew: Treatment outside of protocol | 0 | 1 |
Opioid consumption (MME) over the course of the first 24 hours following surgery
| MME | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Opioid Consumption POD 1 | 86.6 ± 56.3 | 90.5 ± 55 |
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) in the first 24 hours post-op
| units on a scale | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| NRS Pain Score POD 1 | 5.8 ± 1.9 | 5.79 ± 1.76 |
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) on POD 2
| units on a scale | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| NRS Pain Score POD 2 | 5.8 ± 1.9 | 4.55 ± 1.68 |
Numeric rating scale score for pain (rated 0=no pain through 10= worst imaginable pain) during 48-72 hours post-op
| units on a scale | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| NRS Pain Score POD 3 | 2.9 ± 2.0 | 3.36 ± 1.99 |
Time from post-op to step-down from ICU
| days | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| ICU Length of Stay | 5.6 ± 5.6 | 5.6 ± 3.8 |
Opioid consumption (MME) over the course of the 48 hours following surgery
| MME | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Opioid Consumption POD 2 | 40.0 ± 40.3 | 43.0 ± 41.2 |
Opioid consumption (MME) over the course of the 48-72 hours following surgery
| MME | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Opioid Consumption POD 3 | 18.8 ± 24 | 24.3 ± 30.4 |
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 1.
| units on a scale | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Quality of Recovery 15 (QoR-15) Score POD 1 | 87 ± 24 | 84 ± 22 |
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 2.
| units on a scale | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Quality of Recovery 15 (QoR-15) Score POD 2 | 96 ± 18 | 95 ± 16 |
Quality of Recovery 15 (QoR-15) score: 15 question survey (0=very poor recovery through 150=excellent recovery) during POD 3.
| units on a scale | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Quality of Recovery 15 (QoR-15) Score POD 3 | 102 ± 25 | 100 ± 22 |
Time to first antiemetic post-op
| hours | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Time to First Antiemetic | 127 ± 159 | 134 ± 213 |
Time to first bowel movement post-op
| hours | Continuous Infusion | Intermittent Bolus |
|---|---|---|
| Time to First Bowel Movement | 29 ± 22 | 35 ± 30 |
Collected over 0-72 hours post-op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Continuous Infusion | 0/96 (0%) | 0/96 (0%) | 0/96 (0%) |
| Intermittent Bolus | 0/108 (0%) | 0/108 (0%) | 0/108 (0%) |
The baseline analysis included subjects who completed their treatment arm. Subjects who were withdrawn for any reason were excluded from the baseline analysis.
| Age, Continuous(Years) | Continuous Infusion | Intermittent Bolus | Total |
|---|---|---|---|
| Mean | 65.3 ± 29.5 | 64.2 ± 29.2 | 64.5 ± 10.5 |
| Sex: Female, Male(Participants) | Continuous Infusion | Intermittent Bolus | Total |
|---|---|---|---|
| Female | 25 | 30 | 55 |
| Male | 71 | 78 | 149 |
| Race (NIH/OMB)(Participants) | Continuous Infusion | Intermittent Bolus | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 0 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 22 | 33 |
| White | 78 | 73 | 151 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 13 | 17 |
| Body Mass Index(kg/m^2) | Continuous Infusion | Intermittent Bolus | Total |
|---|---|---|---|
| Mean | 29.5 ± 5.2 | 29.2 ± 5.8 | 29.3 ± 5.4 |
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