Post Operative PainPhase 4NCT05642416
Intermittent Bolus vs Continuous Infusion Via ESP Catheters RCT
A Phase 4 study testing Continuous Infusion of ropivacaine and Intermittent bolus of ropivacaine in people with Post Operative Pain, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Continuous Infusion of ropivacaine and Intermittent bolus of ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2022to 23 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Post Operative Pain
- Being tested
- Continuous Infusion of ropivacaine, Intermittent bolus of ropivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Infusion of ropivacaineDrug
Continuous infusion of ropivacaine
Intermittent bolus of ropivacaineDrug
Intermittent bolus of ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Continuous Infusion | Active comparator | 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. Receives: Drug: Continuous Infusion of ropivacaine |
| Intermittent Bolus | Experimental | 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. Receives: Drug: Intermittent bolus of ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption POD 1
Opioid consumption (MME) over the course of the first 24 hours following surgery
Measured: 0-24 hours post-op
Opioid Consumption POD 2
Opioid consumption (MME) over the course of the 48 hours following surgery
Measured: 24-48 hours post-op
Opioid Consumption POD 3
Opioid consumption (MME) over the course of the 48-72 hours following surgery
Measured: 48-72 hours post-op
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 48-72 hrs post-op
ICU Length of Stay
Time from post-op to step-down from ICU
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 48-72 hours post-op
Time to First Antiemetic
Time to first antiemetic post-op
Measured: 0-200 hours post-op
Time to First Bowel Movement
Time to first bowel movement post-op
Measured: 0-72 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start18 Oct 2022
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Avanos Medical
- Responsible party
- Principal investigator, Patrick Forrest, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642416
- Sponsor's protocol ID
- 15737
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2022
- Last updated
- 13 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We will not make individual participant data available to other researchers.
Publications
Forrest PB, Guerra-Londono CE, Nowak K, Meadows A, Dexter F. Intermittent Bolus versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions:A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2026 Sep;40(9):2792-2799. doi: 10.1053/j.jvca.2026.06.010. Epub 2026 Jun 7.
PubMed 42420077
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Bolus Versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05642416
- Acronym / sponsor ID
- 15737
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Avanos Medical
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Posted 13 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Continuous Infusion | Active comparator | Drug: Continuous Infusion of ropivacaineWill 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 | Experimental | Drug: Intermittent bolus of ropivacaineWill 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Infusion of ropivacaineContinuous infusion of ropivacaine | Drug | Continuous Infusion |
| Intermittent bolus of ropivacaineIntermittent bolus of ropivacaine | Drug | Intermittent Bolus |
Primary outcome
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
9 secondary outcomes
NRS Pain Score POD 1
Time frame: 0-24 hrs post-op
NRS Pain Score POD 2
Time frame: 24-48 hrs post-op
NRS Pain Score POD 3
Time frame: 48-72 hrs post-op
ICU Length of Stay
Time frame: 7 days post-op
Quality of Recovery 15 (QoR-15) Score POD 1
Time frame: 0-24 hours post-op
Quality of Recovery 15 (QoR-15) Score POD 2
Time frame: 24-48 hours post-op
Quality of Recovery 15 (QoR-15) Score POD 3
Time frame: 48-72 hours post-op
Time to First Antiemetic
Time frame: 0-200 hours post-op
Time to First Bowel Movement
Time frame: 0-72 hours post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42420077Forrest PB, Guerra-Londono CE, Nowak K, Meadows A, Dexter F. Intermittent Bolus versus Continuous Infusion Erector Spinae Catheters for Median Sternotomy Incisions:A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2026 Sep;40(9):2792-2799. doi: 10.1053/j.jvca.2026.06.010. Epub 2026 Jun 7.
- Individual participant dataSharing planned: No. We will not make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Continuous Infusion of ropivacaine and Intermittent bolus of ropivacaine in people with Post Operative Pain, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption POD 1 (time frame: 0-24 hours post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05642416, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.