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Postoperative PainPhase 4NCT04567407

Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management

A Phase 4 study testing Bilateral erector spinae blocks using ropivacaine in people with Postoperative Pain, run by Boston Children's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open label, interventional study. Read more about this study

Who is it for?
Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Postoperative Pain
What is being tested?
Bilateral erector spinae blocks using ropivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited States
Study dates
22 Sep 2020to 22 Jan 2022
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 2 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Scheduled as part of the cardiac surgical ERAS program: Patients scheduled for elective surgeries for the following congenital anomalies, or similar: atrial septal defects (all types), partial anomalous pulmonary venous connection (non-obstructed), cor-triatriatum, VSD, partial AV canal, sub-aortic membrane resection, anomalous aortic origin of the coronary arteries, and pulmonary valve/conduit implantation
  • Scheduled for a primary sternotomy.
  • Ages 2 years through 17 years.

Who cannot join

  • Single ventricle physiology.
  • Significant scoliosis or other anatomic contraindications to ESB.
  • Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.
  • Patients with severe neurodevelopmental delays.
  • Patients with previous chronic pain syndromes.
  • Patients with a history of greater than 24 hours of postoperative or post-procedural opioid treatment at any point in the 2 months prior to surgery.
  • Lack of parental consent and/or child assent.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Boston Children"S Hospital

    Boston, Massachusetts, 02118

Other trials in United States

About this study

To evaluate the efficacy of bilateral continuous erector spinae blocks (BESB) for postoperative analgesia in children and adolescents undergoing cardiac surgical procedures via sternotomy in the Early Recovery After Surgery (ERAS) program in a single arm, open label, interventional study.

Read the detailed description

Regional anesthesia-and pediatric regional anesthesia in particular-is a rapidly evolving subfield of anesthesia practice driven with considerable urgency by the growing recognition that even appropriate perioperative opioid administration can have significant deleterious long-term effects.

Regional anesthetics can provide targeted, continuous analgesia to select dermatomes with minimal additional patient risk and as such, have become routine components of opioid-sparing intraoperative and postoperative pain management plans for non-cardiac surgical patients at a single institution. In addition to the postulated benefit of reducing overall opioid exposure (and potentially reducing the risk for long term physiologic and behavioral dependence upon opioids), regional anesthetics may allow for earlier extubation after selected surgeries, shorter intensive care unit (ICU) stays, shorter inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and improved patient and care team satisfaction scores.

Historically, regional anesthetics have been avoided in cardiac surgery as most patients are pharmacologically anticoagulated during their procedures and are thus at increased risk for bleeding. This is particularly worrisome in the pediatric cardiac surgical population as many of these children remain intubated for an extended period of time postoperatively and therefore may not have reliable neurological exams in the setting of neuraxial regional anesthetics-potentially resulting in unrecognized hemorrhage-related acquired neurological deficits.

Recently, the erector spinae block (ESB) has become popular for providing analgesia after a number of anterior chest and abdominal procedures. This simple interfascial plane block can reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in numerous case reports and case series as an effective block for management of unilateral thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, for management of post-sternotomy pain when applied bilaterally. New case reports and series involving the ESB are being published almost weekly with a growing number of manuscripts specific to cardiac surgical applications. Indeed, numerous randomized controlled trials have investigated the analgesic efficacy of bilateral erector spinae plane blocks (BESB) compared with conventional treatment for pain after cardiac surgery in adult patients and have been published recently (2018-2019) with promising results.

As an interfascial plane block in a compressible anatomical space, the ESB is considered safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred anesthetic option at BCH for anticoagulated patients - as opposed to neuraxial (e.g. epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely contraindicated in this setting. Further, given its relative ease of placement, apparent efficacy and safety profile, it is increasingly becoming a standard option for patients undergoing a wide range of thoracic, abdominal and thoraco-abdominal procedures.

The investigators recently investigated the feasibility of performing these blocks bilaterally in a pediatric cardiac surgical population undergoing sternotomy-based procedures (IRB-P00031524). At the conclusion of this 10-patient pilot, the investigators found that performing these blocks was technically feasible, requiring 30 minutes or less of OR time, resulting in no known complications. Furthermore, the data suggested an approximate 25% reduction in rescue opioid requirements in the first 48 hours amongst the erector spinae group (p=0.048).

In order to best evaluate the efficacy of this block in the pediatric cardiac population, a blinded, randomized and controlled trial would be ideal. However, given that randomization could be challenging and the fact that blinding would not be feasible, the investigators believe an observational prospective cohort study is most appropriate at this time.

As such, the investigators propose to evaluate the comparative efficacy of BESB versus matched historical controls who received standard of care pain management (systemic opioid therapy) for patients undergoing cardiac surgery via sternotomy by means of a single arm, open label, interventional study that will compare as the primary outcome rescue analgesic requirements, rendered as opiate equivalents, at 12, 24 and 48 hours, and the 24 hour period preceding both 72 and 96 hours postoperatively. 'Efficacy' will be considered as a threshold of clinical significance being defined as a 15% difference). In addition to the primary endpoint, we plan to evaluate the duration of intubation, length of ICU stay, median pain scores, incidence of PONV (postoperative nausea and vomiting; 0-6h, 6-12h and overall), time to mobilization and adverse events between these groups. Postoperative data collected from standard clinical follow-up tools, such as return to baseline sleep and activity status as well as pain medication requirements at home, will also be compared. In addition, the investigators plan to evaluate the quality of sleep and activity with a smart watch (Fitbit™ ) during the perioperative period in the BESB group only.

Being tested
Bilateral erector spinae blocks using ropivacaine
Keywords
regional anesthesia, cardiac surgery, erector spinae
Medical subject headings
Pain, Postoperative

What participants receive

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

  • Bilateral erector spinae blocks using ropivacaineDrug

    Also called Naropin

    Bilateral chest wall nerve blocks using ropivacaine.

Study groups in NCT04567407
Study groupRoleWhat they receive
Bilateral erector spinae blocksExperimentalAll enrolled patients will have bilateral erector spinae blocks (with catheters for postoperative local anesthetic infusion) placed by the by a member of the clinical regional anesthesia team (under the supervision of a member of the research team) in a sterile fashion after the cardiac surgical procedure is completed. Postoperative continuous infusion of local anesthetic (ropivacaine) via the nerve block catheter is initiated and managed by the Acute Pain Service (per standardized, clinical weight-based protocols).
Receives: Drug: Bilateral erector spinae blocks using ropivacaine

What is being measured

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

  1. Analgesic Requirement

    Total opiate equivalents

    Measured: 24hours postop

  2. Analgesic Requirement

    Total opiate equivalents

    Measured: 48hours postop

  3. Analgesic Requirement

    Total opiate equivalents

    Measured: 96hours postop

Secondary outcomes (8)
  1. Duration of Mechanical Ventilation/Intubation

    Length of postoperative mechanical ventilation/intubation following OR exit

    Measured: 48hrs

  2. Length of Postoperative ICU Stay

    Duration of ICU stay following OR exit

    Measured: 72Hours

  3. Length of Hospital Stay

    Duration of Inpatient hospital admission

    Measured: 5 Days

  4. Median Pain Scores

    Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

    Measured: day of surgery (POD 0) 7:00am - 18:59pm

  5. Median Pain Scores

    Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

    Measured: night of surgery (PON 0) 19:00pm-6:59am

  6. Median Pain Scores

    Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

    Measured: Post-Op Day 1 (7:00am-18:59pm)

  7. Median Pain Scores

    Patient reported pain scores using either NRS score (numeric rating scale of 1-10, with 10 being the worst pain), the INRS score (individualized numeric rating scale of 1-10, with 10 being the worst pain) or FLACC scale (face, legs, activity, cry, consolability scale of 0-10 with 10 being the worst pain). Patients were assessed multiple times (variably - per routine clinical practice, every few hours during the Time Frame) in order to derive a median for each participant per 12h period. Median pain scores were used rather than time specific pain scores to compare patients in the single arm cohort study to controls from the ERAS controls. Median pain scores were averaged across all participants in the intervention arm as well as the controls. Outcomes are reported as mean with the standard error.

    Measured: Post-Op Night 1 (19:00pm-6:59am)

  8. Time to First Mobilization

    Time to out of bed activity (e.g., up to chair, ambulation)

    Measured: 48 hours

Timeline

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

  1. First posted28 Sep 2020
  2. Study start22 Sep 2020
  3. Primary completion22 Jan 2022
  4. Study completion22 Jan 2022

Resources

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
Not applicable
Intervention model
Single group
Model description
Prospective single-arm intervention trial
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04567407
Sponsor's protocol ID
IRB-P00034302
Status last verified
Sep 2023
First submitted
18 Sep 2020
Last updated
17 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: No current plan to share data.

Publications

  • Roy N, Parra MF, Brown ML, Sleeper LA, Kossowsky J, Baumer AM, Blitz SE, Booth JM, Higgins CE, Nasr VG, Del Nido PJ, Brusseau R. Erector spinae plane blocks for opioid-sparing multimodal pain management after pediatric cardiac surgery. J Thorac Cardiovasc Surg. 2024 Dec;168(6):1742-1750.e9. doi: 10.1016/j.jtcvs.2024.03.010. Epub 2024 Mar 16.

    PubMed 38493959

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bilateral erector spinae blocks using ropivacaine in people with Postoperative Pain, run by Boston Children's Hospital 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 3 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 17 Oct 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.

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 17 Oct 2023). 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?

Analgesic Requirement (time frame: 24hours postop). 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 NCT04567407, 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 17 Oct 2023.

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Clinical Trial NCT04567407 | AzTrials