Opioid UseRACERNCT03781440

Regional Anesthesia for Cardiothoracic Enhanced Recovery

A study testing Bilateral ESP catheter with lidocaine and Bilateral ESP catheter with saline in people with Opioid Use and Anesthesia, Local, run by Stanford University at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The erector spinae plane block (ESPB) is a novel regional analgesic technique that provides pain relief with a peripheral nerve block catheter. The goal of this study is to see if bilateral ESPB catheters can improve clinical outcomes in patients undergoing cardiac surgery via sternotomy, such as decreasing the… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Opioid Use, Anesthesia, Local, Cardiac Disease
What is being tested?: Bilateral ESP catheter with lidocaine and Bilateral ESP catheter with saline
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2020to Dec 2023
Phase: Interventional
Are there results?: None posted in the registry

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Give consent to participate in study
planned sternotomy
specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these
Primary or first redo sternotomy

Who cannot join

Participants who cannot give consent
Patients who are clinically unstable or require urgent/emergent intervention
more than1 prior sternotomy
planned aortic arch procedures
preoperative coagulopathy (INR >1.5, PTT >35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy)
Severe ventricular dysfunction (left or right ventricle)
Symptomatic heart failure (systolic or diastolic)

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy

Conditions: Opioid Use, Anesthesia, Local, Cardiac Disease, Pain, Acute
Being tested: Bilateral ESP catheter with lidocaine, Bilateral ESP catheter with saline
Medical subject headings: Heart Diseases, Acute Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bilateral ESP catheter with lidocaineProcedure or surgery
All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
Bilateral ESP catheter with salineProcedure or surgery
All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).

Study groups in NCT03781440
Study group	Role	What they receive
Bilateral ESP catheter with Lidocaine	Experimental	All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest). Receives: Procedure: Bilateral ESP catheter with lidocaine
Bilateral ESP catheter with saline	Placebo comparator	All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest). Receives: Procedure: Bilateral ESP catheter with saline

What is being measured

The primary outcome is the main question the study is designed to answer.

Opioid Consumption
IV and PO opioid requirements converted to morphine equivalent
Measured: Duration of postoperative recovery (typically 1-2 weeks)

Secondary outcomes (7)

Delirium and agitation post-operatively
Richmond Agitation-Sedation Score from -5 to +4 (-5 is the most sedation, +4 is the least sedated.
Measured: Duration of ICU stay (typically 2-5 days)
Determine post-operative pain scores
11-point numerical rating scale (NRS) from 0-10, 0 signifying no pain, 10 signifying the worse pain.
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Median time to extubation in patients with ESPB
duration in mechanical ventilation in hours
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Length of stay in hospital
number of post-operative days spent in hospital
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Length of stay in ICU
number of post-operative days spent in ICU
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Quality of recovery at 72 hours
Survey based (Quality of Recover 15) patient reported outcomes. There are 15 questions based on a scale of 0-10 per questions, 0 signifying the worst outcome, 10 signifying the best, for a score range of 0-150.
Measured: post-operative day 3
Inflammatory biomarker analysis
Pro and anti-inflammatory biomarker panel at 4 time points perioperatively. We will be analyzing IL10 concentrations as an anti-inflammatory biomarker and IL6 and TN alpha as pro-inflammatory biomarkers in either a ELISA assay or Luminex.
Measured: First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 2020Dec 2023

First posted19 Dec 2018
Study start1 Jan 2020
Primary completion30 Sep 2021
Study completionDec 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Opioid UseStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03781440
Sponsor's protocol ID: 47647
Acronym: RACER
Status last verified: Sep 2023
First submitted: 18 Dec 2018
Last updated: 22 Sep 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
PubMed 14622770
Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.
PubMed 23076899
Baikoussis NG, Papakonstantinou NA, Verra C, Kakouris G, Chounti M, Hountis P, Dedeilias P, Argiriou M. Mechanisms of oxidative stress and myocardial protection during open-heart surgery. Ann Card Anaesth. 2015 Oct-Dec;18(4):555-64. doi: 10.4103/0971-9784.166465.
PubMed 26440242
Giomarelli P, Scolletta S, Borrelli E, Biagioli B. Myocardial and lung injury after cardiopulmonary bypass: role of interleukin (IL)-10. Ann Thorac Surg. 2003 Jul;76(1):117-23. doi: 10.1016/s0003-4975(03)00194-2.
PubMed 12842524
Fragiadakis GK, Gaudilliere B, Ganio EA, Aghaeepour N, Tingle M, Nolan GP, Angst MS. Patient-specific Immune States before Surgery Are Strong Correlates of Surgical Recovery. Anesthesiology. 2015 Dec;123(6):1241-55. doi: 10.1097/ALN.0000000000000887.
PubMed 26655308
Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
PubMed 25253674
Eljezi V, D'Ostrevy N. Local Anesthetic Diffusion of Bilateral Sternal Block After Cardiac Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):418-419. doi: 10.1097/AAP.0000000000000577. No abstract available.
PubMed 28419054
Chaudhary V, Chauhan S, Choudhury M, Kiran U, Vasdev S, Talwar S. Parasternal intercostal block with ropivacaine for postoperative analgesia in pediatric patients undergoing cardiac surgery: a double-blind, randomized, controlled study. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):439-42. doi: 10.1053/j.jvca.2011.10.012. Epub 2011 Dec 16.
PubMed 22176767
Olivier JF, Bracco D, Nguyen P, Le N, Noiseux N, Hemmerling T; Perioperative Cardiac Surgery Research Group (PeriCARG). A novel approach for pain management in cardiac surgery via median sternotomy: bilateral single-shot paravertebral blocks. Heart Surg Forum. 2007;10(5):E357-62. doi: 10.1532/HSF98.20071082.
PubMed 17855198
Canto M, Sanchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70. doi: 10.1046/j.1365-2044.2003.03082_2.x.
PubMed 12688271
Lockwood GG, Cabreros L, Banach D, Punjabi PP. Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial. Perfusion. 2017 Oct;32(7):591-597. doi: 10.1177/0267659117715507. Epub 2017 Jun 7.
PubMed 28592166
Svircevic V, Nierich AP, Moons KG, Diephuis JC, Ennema JJ, Brandon Bravo Bruinsma GJ, Kalkman CJ, van Dijk D. Thoracic epidural anesthesia for cardiac surgery: a randomized trial. Anesthesiology. 2011 Feb;114(2):262-70. doi: 10.1097/ALN.0b013e318201d2de.
PubMed 21239976
Chakravarthy M, Thimmangowda P, Krishnamurthy J, Nadiminti S, Jawali V. Thoracic epidural anesthesia in cardiac surgical patients: a prospective audit of 2,113 cases. J Cardiothorac Vasc Anesth. 2005 Feb;19(1):44-8. doi: 10.1053/j.jvca.2004.11.008.
PubMed 15747268
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
PubMed 27501016
Kose HC, Kose SG, Thomas DT. Lumbar versus thoracic erector spinae plane block: Similar nomenclature, different mechanism of action. J Clin Anesth. 2018 Aug;48:1. doi: 10.1016/j.jclinane.2018.03.026. Epub 2018 Apr 9. No abstract available.
PubMed 29649625

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Regional Anesthesia for Cardiothoracic Enhanced Recovery for Patients Undergoing Cardiac Surgery Via Sternotomy
ClinicalTrials.gov ID: NCT03781440
Acronym / sponsor ID: RACER / 47647
Conditions: Opioid Use, Anesthesia, Local, Cardiac Disease, Pain, Acute
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 60 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Study start: 1 Jan 2020 (actual)
Primary completion: 30 Sep 2021 (actual)
Study completion: Dec 2023 (estimated)
First posted: 19 Dec 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Bilateral ESP catheter with Lidocaine	Experimental	Procedure: Bilateral ESP catheter with lidocaineAll participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
Bilateral ESP catheter with saline	Placebo comparator	Procedure: Bilateral ESP catheter with salineAll participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Give consent to participate in study
planned sternotomy
specific procedures: CABG (coronary artery bypass grafting) or AVR (aortic valve repair or replacement) or MVR (mitral valve repair or replacement) or combination of any of 2 of these
Primary or first redo sternotomy

Key exclusion criteria (7 listed)

Participants who cannot give consent
Patients who are clinically unstable or require urgent/emergent intervention
more than1 prior sternotomy
planned aortic arch procedures
preoperative coagulopathy (INR >1.5, PTT >35) or ongoing anticoagulation (heparin infusion, therapeutic low molecular weight heparin, warfarin, dual antiplatelet therapy)

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
Bilateral ESP catheter with lidocaineAll participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).	Procedure or surgery	Bilateral ESP catheter with Lidocaine
Bilateral ESP catheter with salineAll participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).	Procedure or surgery	Bilateral ESP catheter with saline

Primary outcome

Opioid Consumption
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
IV and PO opioid requirements converted to morphine equivalent

7 secondary outcomes

Delirium and agitation post-operatively
Time frame: Duration of ICU stay (typically 2-5 days)
Determine post-operative pain scores
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Median time to extubation in patients with ESPB
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Length of stay in hospital
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Length of stay in ICU
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Quality of recovery at 72 hours
Time frame: post-operative day 3
Inflammatory biomarker analysis
Time frame: First panel pre-incision; second panel 6hrs (+/-3hrs) post-procedure; third panel 24hrs (+/-3hrs) post-procedure; fourth panel 48hrs (+/-3hrs) post-procedure

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
Background: PubMed 14622770Wheeler M, Oderda GM, Ashburn MA, Lipman AG. Adverse events associated with postoperative opioid analgesia: a systematic review. J Pain. 2002 Jun;3(3):159-80. doi: 10.1054/jpai.2002.123652. No abstract available.
Background: PubMed 23076899Zhu F, Lee A, Chee YE. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2012 Oct 17;10:CD003587. doi: 10.1002/14651858.CD003587.pub2.
Background: PubMed 26440242Baikoussis NG, Papakonstantinou NA, Verra C, Kakouris G, Chounti M, Hountis P, Dedeilias P, Argiriou M. Mechanisms of oxidative stress and myocardial protection during open-heart surgery. Ann Card Anaesth. 2015 Oct-Dec;18(4):555-64. doi: 10.4103/0971-9784.166465.
Background: PubMed 12842524Giomarelli P, Scolletta S, Borrelli E, Biagioli B. Myocardial and lung injury after cardiopulmonary bypass: role of interleukin (IL)-10. Ann Thorac Surg. 2003 Jul;76(1):117-23. doi: 10.1016/s0003-4975(03)00194-2.
Background: PubMed 26655308Fragiadakis GK, Gaudilliere B, Ganio EA, Aghaeepour N, Tingle M, Nolan GP, Angst MS. Patient-specific Immune States before Surgery Are Strong Correlates of Surgical Recovery. Anesthesiology. 2015 Dec;123(6):1241-55. doi: 10.1097/ALN.0000000000000887.
Background: PubMed 25253674Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.
Background: PubMed 28419054Eljezi V, D'Ostrevy N. Local Anesthetic Diffusion of Bilateral Sternal Block After Cardiac Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):418-419. doi: 10.1097/AAP.0000000000000577. No abstract available.
Background: PubMed 22176767Chaudhary V, Chauhan S, Choudhury M, Kiran U, Vasdev S, Talwar S. Parasternal intercostal block with ropivacaine for postoperative analgesia in pediatric patients undergoing cardiac surgery: a double-blind, randomized, controlled study. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):439-42. doi: 10.1053/j.jvca.2011.10.012. Epub 2011 Dec 16.
Background: PubMed 17855198Olivier JF, Bracco D, Nguyen P, Le N, Noiseux N, Hemmerling T; Perioperative Cardiac Surgery Research Group (PeriCARG). A novel approach for pain management in cardiac surgery via median sternotomy: bilateral single-shot paravertebral blocks. Heart Surg Forum. 2007;10(5):E357-62. doi: 10.1532/HSF98.20071082.
Background: PubMed 12688271Canto M, Sanchez MJ, Casas MA, Bataller ML. Bilateral paravertebral blockade for conventional cardiac surgery. Anaesthesia. 2003 Apr;58(4):365-70. doi: 10.1046/j.1365-2044.2003.03082_2.x.
Background: PubMed 28592166Lockwood GG, Cabreros L, Banach D, Punjabi PP. Continuous bilateral thoracic paravertebral blockade for analgesia after cardiac surgery: a randomised, controlled trial. Perfusion. 2017 Oct;32(7):591-597. doi: 10.1177/0267659117715507. Epub 2017 Jun 7.
Background: PubMed 21239976Svircevic V, Nierich AP, Moons KG, Diephuis JC, Ennema JJ, Brandon Bravo Bruinsma GJ, Kalkman CJ, van Dijk D. Thoracic epidural anesthesia for cardiac surgery: a randomized trial. Anesthesiology. 2011 Feb;114(2):262-70. doi: 10.1097/ALN.0b013e318201d2de.
Individual participant dataSharing planned: No

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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.

Jessica Brodt, MD principal investigator

Stanford University

Ban Tsui, MD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Bilateral ESP catheter with lidocaine and Bilateral ESP catheter with saline in people with Opioid Use and Anesthesia, Local, run by Stanford University 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 4 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: status not confirmed, as of the sponsor's last update on 22 Sep 2023. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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 (time frame: Duration of postoperative recovery (typically 1-2 weeks)). 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 NCT03781440, which also lists 18 linked publications.

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 22 Sep 2023; AzTrials last refreshed its copy on 1 Nov 2026.