Congenital Heart DefectNCT03611374
Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study
A study testing Bilateral Erector Spinae Plane Block (ESPB) in people with Congenital Heart Defect and Congenital Heart Disease, run by Stanford University at 1 site in United States.
Trial summary
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and… Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Congenital Heart Defect, Congenital Heart Disease, Anesthesia, Local
- What is being tested?
- Bilateral Erector Spinae Plane Block (ESPB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2019to 6 Apr 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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries
Who cannot join
- Participants who do not consent or have parental consent ii) Patients who are clinically unstable or require urgent/emergent intervention iii) Patients under 5kg
Trial locations and contacts
1 site in 1 country.
United States1 site
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304
About this study
Official title: Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) for Patients Undergoing Sternotomy for Congenital Heart Repair
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days in the intensive care unit (ICU) and length of stay (LOS).
- Being tested
- Bilateral Erector Spinae Plane Block (ESPB)
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Erector Spinae Plane Block (ESPB)Procedure or surgery
Bilateral ESPBs will be placed after anesthesia induction in eligible and consented patients who are undergoing a sternotomy for congenital heart repair. Patients will receive a local anesthetic agent through each catheter prior to surgery start. If possible, levels of the local anesthetic will be measured during the case. After surgery, patients will be admitted to the CVICU and extubation will be managed by the CVICU team. The ESPB group will have an automatic, alternating side boluses of the local anesthetic started through their nerve block catheters. Levels of the local anesthetic will be measured at intervals.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Experimental | All participants will get the Erector Spinae Plane block (ESPB) as a prospective cohort study. After anesthesia induction all enrolled patients will have bilateral ESPB catheters placed at the T7 spine level prior to surgery. The surgery is a sternotomy for congenital heart repair in high risk children and adults. Receives: Procedure: Bilateral Erector Spinae Plane Block (ESPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to extubation in patients with ESPB
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Determine average post-operative pain scores in patients with ESPB
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Determine opioid consumption
Measured: Duration of postoperative recovery (typically 1-2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start7 Jun 2019
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
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 Congenital Heart DefectStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Caruso, Stanford University
- Investigators
- Thomas Caruso, MD, MEd, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611374
- Sponsor's protocol ID
- 47032
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2018
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kain ZN, Fitch JC, Kirsch JR, Mets B, Pearl RG. Future of anesthesiology is perioperative medicine: a call for action. Anesthesiology. 2015 Jun;122(6):1192-5. doi: 10.1097/ALN.0000000000000680. No abstract available.
PubMed 25886775Ramamoorthy C, Haberkern CM, Bhananker SM, Domino KB, Posner KL, Campos JS, Morray JP. Anesthesia-related cardiac arrest in children with heart disease: data from the Pediatric Perioperative Cardiac Arrest (POCA) registry. Anesth Analg. 2010 May 1;110(5):1376-82. doi: 10.1213/ANE.0b013e3181c9f927. Epub 2010 Jan 26.
PubMed 20103543Fukunishi T, Oka N, Yoshii T, Kobayashi K, Inoue N, Horai T, Kitamura T, Okamoto H, Miyaji K. Early Extubation in the Operating Room after Congenital Open-Heart Surgery. Int Heart J. 2018 Jan 27;59(1):94-98. doi: 10.1536/ihj.16-630. Epub 2018 Jan 15.
PubMed 29332913Bhalla AK, Yehya N, Mack WJ, Wilson ML, Khemani RG, Newth CJL. The Association Between Inhaled Nitric Oxide Treatment and ICU Mortality and 28-Day Ventilator-Free Days in Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2018 Nov;46(11):1803-1810. doi: 10.1097/CCM.0000000000003312.
PubMed 30028363Agarwal HS, Wolfram KB, Saville BR, Donahue BS, Bichell DP. Postoperative complications and association with outcomes in pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2014 Aug;148(2):609-16.e1. doi: 10.1016/j.jtcvs.2013.10.031. Epub 2013 Nov 23.
PubMed 24280709Diaz LK. Anesthesia and postoperative analgesia in pediatric patients undergoing cardiac surgery. Paediatr Drugs. 2006;8(4):223-33. doi: 10.2165/00148581-200608040-00002.
PubMed 16898853Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.
PubMed 1530752Pollak U, Serraf A. Pediatric Cardiac Surgery and Pain Management: After 40 Years in the Desert, Have We Reached the Promised Land? World J Pediatr Congenit Heart Surg. 2018 May;9(3):315-325. doi: 10.1177/2150135118755977.
PubMed 29692232Brix-Christensen V. The systemic inflammatory response after cardiac surgery with cardiopulmonary bypass in children. Acta Anaesthesiol Scand. 2001 Jul;45(6):671-9. doi: 10.1034/j.1399-6576.2001.045006671.x.
PubMed 11421823Gaudilliere 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 25253674Fragiadakis 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 26655308Hickey PR, Hansen DD. High-dose fentanyl reduces intraoperative ventricular fibrillation in neonates with hypoplastic left heart syndrome. J Clin Anesth. 1991 Jul-Aug;3(4):295-300. doi: 10.1016/0952-8180(91)90223-a.
PubMed 1910797Chaudhary 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 22176767Olivier 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 17855198Chakravarthy 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) for Patients Undergoing Sternotomy for Congenital Heart Repair
- ClinicalTrials.gov ID
- NCT03611374
- Acronym / sponsor ID
- 47032
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 7 Jun 2019 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 2 Aug 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.
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days in the intensive care unit (ICU) and length of stay (LOS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Procedure: Bilateral Erector Spinae Plane Block (ESPB)All participants will get the Erector Spinae Plane block (ESPB) as a prospective cohort study. After anesthesia induction all enrolled patients will have bilateral ESPB catheters placed at the T7 spine level prior to surgery. The surgery is a sternotomy for congenital heart repair in high risk children and adults. |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries
Key exclusion criteria (1 listed)
- Participants who do not consent or have parental consent ii) Patients who are clinically unstable or require urgent/emergent intervention iii) Patients under 5kg
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 Erector Spinae Plane Block (ESPB)Bilateral ESPBs will be placed after anesthesia induction in eligible and consented patients who are undergoing a sternotomy for congenital heart repair. Patients will receive a local anesthetic agent through each catheter prior to surgery start. If possible, levels of the local anesthetic will be measured during the case. After surgery, patients will be admitted to the CVICU and extubation will be managed by the CVICU team. The ESPB group will have an automatic, alternating side boluses of the local anesthetic started through their nerve block catheters. Levels of the local anesthetic will be measured at intervals. | Procedure or surgery | Erector Spinae Plane Block |
Primary outcome
Median time to extubation in patients with ESPB
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Median Cardiovascular Intensive Care Unit (CVICU) LOS in patients with ESPB
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Determine average post-operative pain scores in patients with ESPB
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Determine opioid consumption
Time frame: Duration of postoperative recovery (typically 1-2 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 25886775Kain ZN, Fitch JC, Kirsch JR, Mets B, Pearl RG. Future of anesthesiology is perioperative medicine: a call for action. Anesthesiology. 2015 Jun;122(6):1192-5. doi: 10.1097/ALN.0000000000000680. No abstract available.
- Background: PubMed 20103543Ramamoorthy C, Haberkern CM, Bhananker SM, Domino KB, Posner KL, Campos JS, Morray JP. Anesthesia-related cardiac arrest in children with heart disease: data from the Pediatric Perioperative Cardiac Arrest (POCA) registry. Anesth Analg. 2010 May 1;110(5):1376-82. doi: 10.1213/ANE.0b013e3181c9f927. Epub 2010 Jan 26.
- Background: PubMed 29332913Fukunishi T, Oka N, Yoshii T, Kobayashi K, Inoue N, Horai T, Kitamura T, Okamoto H, Miyaji K. Early Extubation in the Operating Room after Congenital Open-Heart Surgery. Int Heart J. 2018 Jan 27;59(1):94-98. doi: 10.1536/ihj.16-630. Epub 2018 Jan 15.
- Background: PubMed 30028363Bhalla AK, Yehya N, Mack WJ, Wilson ML, Khemani RG, Newth CJL. The Association Between Inhaled Nitric Oxide Treatment and ICU Mortality and 28-Day Ventilator-Free Days in Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2018 Nov;46(11):1803-1810. doi: 10.1097/CCM.0000000000003312.
- Background: PubMed 24280709Agarwal HS, Wolfram KB, Saville BR, Donahue BS, Bichell DP. Postoperative complications and association with outcomes in pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2014 Aug;148(2):609-16.e1. doi: 10.1016/j.jtcvs.2013.10.031. Epub 2013 Nov 23.
- Background: PubMed 16898853Diaz LK. Anesthesia and postoperative analgesia in pediatric patients undergoing cardiac surgery. Paediatr Drugs. 2006;8(4):223-33. doi: 10.2165/00148581-200608040-00002.
- Background: PubMed 1530752Anand KJ, Hickey PR. Halothane-morphine compared with high-dose sufentanil for anesthesia and postoperative analgesia in neonatal cardiac surgery. N Engl J Med. 1992 Jan 2;326(1):1-9. doi: 10.1056/NEJM199201023260101.
- Background: PubMed 29692232Pollak U, Serraf A. Pediatric Cardiac Surgery and Pain Management: After 40 Years in the Desert, Have We Reached the Promised Land? World J Pediatr Congenit Heart Surg. 2018 May;9(3):315-325. doi: 10.1177/2150135118755977.
- Background: PubMed 11421823Brix-Christensen V. The systemic inflammatory response after cardiac surgery with cardiopulmonary bypass in children. Acta Anaesthesiol Scand. 2001 Jul;45(6):671-9. doi: 10.1034/j.1399-6576.2001.045006671.x.
- 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 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 1910797Hickey PR, Hansen DD. High-dose fentanyl reduces intraoperative ventricular fibrillation in neonates with hypoplastic left heart syndrome. J Clin Anesth. 1991 Jul-Aug;3(4):295-300. doi: 10.1016/0952-8180(91)90223-a.
- 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.
Thomas Caruso, MD, MEd 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 Erector Spinae Plane Block (ESPB) in people with Congenital Heart Defect and Congenital Heart Disease, 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 1 inclusion and 1 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 28 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Median time to extubation in patients with ESPB (time frame: Duration of postoperative recovery (typically 1-2 weeks)). The study lists 4 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 NCT03611374, 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 28 Sep 2023.