Pain, PostoperativePhase 3NCT03936387
Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
A Phase 3 study testing Ropivacaine in people with Pain, Postoperative, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy prior to planning an appropriately powered, randomized, controlled trial of the same. Read more about this study
- Who is it for?
- Ages 3 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ropivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 12 Sep 2019
- Phase
- Phase 3
- 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 3 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Scheduled as part of the cardiac surgical ERAS program.
- Scheduled for a primary sternotomy.
- Ages 3-21 years.
Who cannot join
- Patients undergoing reoperative procedures.
- Significant scoliosis or other anatomic contraindications to ESB.
- History of bleeding or current therapeutic dose anticoagulant use.
- 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 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
About this study
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy prior to planning an appropriately powered, randomized, controlled trial of the same.
Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae blocks for post-sternotomy pain is a feasible intervention for consideration in a larger trial by demonstrating a 75% or greater successful intervention completion rate without any major adverse outcomes.
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 narcotic administration can have significant derogatory 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 surgical patients at BCH. 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 ICU, PACU and inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and improved patient satisfaction scores.
Despite a robust literature supporting the safety and efficacy of regional anesthesia for postoperative pain control across a broad range or surgery types, patient demographics and underlying comorbidities, there are certain classes of surgeries that have (to date) not benefitted from the advantages that regional anesthetics may provide, most notably spine surgery and cardiac surgery.
Concerns have been expressed with regard to regional anesthetics for cardiac surgeries in particular (this being the primary surgical type associated with sternotomies in a pediatric populations), given that most patients are pharmacologically anticoagulated to some extent during their procedures and are thus at increased risk for bleeding. This is further complicated in the pediatric cardiac surgical population as many of these children are intubated for an extended period of time and therefore may not have particularly reliable neurological exams in the setting of neuraxial regional anesthetics-potentially resulting in unrecognized acquired neurological defecits. While there is emerging evidence of improved outcomes with neuraxial regional anesthetics in adult cardiac surgery patients, this has not trickled down to the pediatric population, likely for some of these reasons.
The investigators at BCH are fortunate to have one of the largest concentrated pediatric cardiac surgical populations in the US along with an active, and well organized regional anesthesia service. Because of this, the investigators are in a unique position to more thoroughly evaluate the effectiveness and safety of regional anesthetics in children following cardiac surgery. Furthermore it is thought to be critical that institutions such as BCH take a leading role in documenting the effects of regional anesthesia on the most important outcome measures when considering perioperative medicine. These include: overall pain management, surgical healing, functional recovery, long term pain symptoms, and emotional/behavioral outcomes after surgery.
Recently, the erector spinae block (ESB) has become popular for providing analgesia after a number of anterior chest and abdominal procedures. This is a simple interfascial plane block that can reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in numerous case reports and one case series as an effective block for management of unilateral thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, when used bilaterally, for management of post-sternotomy pain. New case reports and series involving the ESB are being published almost weekly at this point with a growing literature specific to cardiac surgical applications. Indeed a randomized controlled trial to investigate the analgesic efficacy of bilateral erector spinae plane (BESP) blocks compared with conventional treatment for pain after cardiac surgery in adult patients was published recently (2018) with promising results.
As an interfascial plane block in a compressible anatomical space, the ESB is thought to be safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred anesthetic option for these pharmacologically or otherwise coagulopathic patients as opposed to neuraxial (e.g. epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely contraindicated in this setting.
Given the ESB's potentially favorable risk profile versus the other blocks that would subserve the same dermatomes (i.e. it is technically less challenging, more distant from critical structures, and thought to be safe in anticoagulated patients) it could provide both a safer and easier to perform regional anesthesia option for many patients. In particular, it offers a new option for a subset of anticoagulated patients for whom other regional techniques (epidural, paravertebral) are contraindicated. This is particularly true for the populations of pediatric cardiac surgical patients at BCH if used bilaterally.
Indeed, given the current information available related to the ESB, the regional anesthesia service at BCH has begun employing it when possible in circumstances when a neuraxial or paravertebral block(s) would commonly be used but is/are relatively or absolutely contraindicated. Patients undergoing thoracotomies while anticoagulated for cardiopulmonary bypass, aortic clamping, etc. have been successfully managed with unilateral continuous ESBs. In addition, thoracotomies in patients with acquired (e.g. dilutional) and other pathologic coagulopathies have been managed with ESBs. As such, the ESB has been adopted for routine use in specific patient populations at BCH and has even occasionally been utilized in lieu of the more longstanding routine PVBs or epidural blocks for patients without contraindication for such.
Retrospective review of BCH outcomes data for 67 ESBs done for a variety of surgeries and populations has not revealed any significant differences between PVBs and ESBs in terms of adverse events, postoperative opiate use, median pain scores, or other standard outcomes measures. As this data is observational in nature, it is difficult to draw firm conclusions as to the efficacy of the two blocks. However, since there are distinct known and described advantages associated with regional anesthetics for postoperative pain management, it would be prudent to evaluate these blocks in a controlled, randomized, trial. Prior to such a trial, a pilot study to evaluate the feasibility of such a trial is warranted.
As such, the investigators propose to evaluate the feasibility of investigating bilateral continuous erector spinae blocks (BESB) for patients undergoing surgical sternotomy by means of a pilot study. For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes. Secondary measures of feasibility will include aggregate 'data integrity' as defined by successful collection of 75% or greater of all possible data points for successfully completed subjects as well as 'efficient intervention duration' as evaluated by intervention completion time being less than 40 minutes.
- Conditions
- Pain, Postoperative
- Being tested
- Ropivacaine
- Keywords
- erector spinae block, regional anesthesia, sternotomy, 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.
RopivacaineDrug
Also called Naropin
Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral erector spinae blocks | Experimental | Bilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Completed a Successful Intervention With No Major Adverse Events
For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes.
Measured: 48 hours
Secondary outcomes (1)
Number of Participants Who Completed a Successful Intervention With a Full Data Set
Secondary measures of feasibility will include aggregate 'data integrity' as defined by successful collection of 75% or greater of all possible data points for successfully completed subjects as well as 'efficient intervention duration' as evaluated by intervention completion time being less than 40 minutes.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start1 Jul 2019
- Primary completion1 Sep 2019
- Study completion12 Sep 2019
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.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single intervention group, bilateral erector spinae blocks with 0.2% ropivacaine, to assess the feasibility of this technique for postoperative pain control following surgeries involving sternotomies in children.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roland Brusseau, Boston Children's Hospital
- Investigators
- ROLAND BRUSSEAU, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936387
- Sponsor's protocol ID
- IRB-P00031524
- Status last verified
- Mar 2021
- First submitted
- 1 May 2019
- Last updated
- 5 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Continuous Erector Spinae Blocks for Post-Sternotomy Pain Management: A Pilot Study
- ClinicalTrials.gov ID
- NCT03936387
- Acronym / sponsor ID
- IRB-P00031524
- Conditions
- Pain, Postoperative
- Keywords
- erector spinae block, regional anesthesia, sternotomy, ropivacaine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 12 Sep 2019 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Posted 5 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Overall Aim: To evaluate the feasibility and potential benefits of investigating bilateral continuous erector spinae blocks (BESB) for postoperative pain management in a small cohort of children undergoing surgical sternotomy prior to planning an appropriately powered, randomized, controlled trial of the same.
Hypothesis: The investigators' primary hypothesis is that utilizing bilateral erector spinae blocks for post-sternotomy pain is a feasible intervention for consideration in a larger trial by demonstrating a 75% or greater successful intervention completion rate without any major adverse outcomes.
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 narcotic administration can have significant derogatory 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 surgical patients at BCH. 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 ICU, PACU and inpatient admissions, earlier mobilization, fewer gastrointestinal complications, and improved patient satisfaction scores.
Despite a robust literature supporting the safety and efficacy of regional anesthesia for postoperative pain control across a broad range or surgery types, patient demographics and underlying comorbidities, there are certain classes of surgeries that have (to date) not benefitted from the advantages that regional anesthetics may provide, most notably spine surgery and cardiac surgery.
Concerns have been expressed with regard to regional anesthetics for cardiac surgeries in particular (this being the primary surgical type associated with sternotomies in a pediatric populations), given that most patients are pharmacologically anticoagulated to some extent during their procedures and are thus at increased risk for bleeding. This is further complicated in the pediatric cardiac surgical population as many of these children are intubated for an extended period of time and therefore may not have particularly reliable neurological exams in the setting of neuraxial regional anesthetics-potentially resulting in unrecognized acquired neurological defecits. While there is emerging evidence of improved outcomes with neuraxial regional anesthetics in adult cardiac surgery patients, this has not trickled down to the pediatric population, likely for some of these reasons.
The investigators at BCH are fortunate to have one of the largest concentrated pediatric cardiac surgical populations in the US along with an active, and well organized regional anesthesia service. Because of this, the investigators are in a unique position to more thoroughly evaluate the effectiveness and safety of regional anesthetics in children following cardiac surgery. Furthermore it is thought to be critical that institutions such as BCH take a leading role in documenting the effects of regional anesthesia on the most important outcome measures when considering perioperative medicine. These include: overall pain management, surgical healing, functional recovery, long term pain symptoms, and emotional/behavioral outcomes after surgery.
Recently, the erector spinae block (ESB) has become popular for providing analgesia after a number of anterior chest and abdominal procedures. This is a simple interfascial plane block that can reliably provide unilateral chest and/or abdominal wall analgesia. It has been described in numerous case reports and one case series as an effective block for management of unilateral thoracotomies, unilateral rib fractures, unilateral abdominal incisions and most notably, when used bilaterally, for management of post-sternotomy pain. New case reports and series involving the ESB are being published almost weekly at this point with a growing literature specific to cardiac surgical applications. Indeed a randomized controlled trial to investigate the analgesic efficacy of bilateral erector spinae plane (BESP) blocks compared with conventional treatment for pain after cardiac surgery in adult patients was published recently (2018) with promising results.
As an interfascial plane block in a compressible anatomical space, the ESB is thought to be safe in anticoagulated (or recently anticoagulated) patients. It is fast becoming a preferred anesthetic option for these pharmacologically or otherwise coagulopathic patients as opposed to neuraxial (e.g. epidural) and paraneuraxial blocks (i.e. paravertebral) nerve blocks, which are largely contraindicated in this setting.
Given the ESB's potentially favorable risk profile versus the other blocks that would subserve the same dermatomes (i.e. it is technically less challenging, more distant from critical structures, and thought to be safe in anticoagulated patients) it could provide both a safer and easier to perform regional anesthesia option for many patients. In particular, it offers a new option for a subset of anticoagulated patients for whom other regional techniques (epidural, paravertebral) are contraindicated. This is particularly true for the populations of pediatric cardiac surgical patients at BCH if used bilaterally.
Indeed, given the current information available related to the ESB, the regional anesthesia service at BCH has begun employing it when possible in circumstances when a neuraxial or paravertebral block(s) would commonly be used but is/are relatively or absolutely contraindicated. Patients undergoing thoracotomies while anticoagulated for cardiopulmonary bypass, aortic clamping, etc. have been successfully managed with unilateral continuous ESBs. In addition, thoracotomies in patients with acquired (e.g. dilutional) and other pathologic coagulopathies have been managed with ESBs. As such, the ESB has been adopted for routine use in specific patient populations at BCH and has even occasionally been utilized in lieu of the more longstanding routine PVBs or epidural blocks for patients without contraindication for such.
Retrospective review of BCH outcomes data for 67 ESBs done for a variety of surgeries and populations has not revealed any significant differences between PVBs and ESBs in terms of adverse events, postoperative opiate use, median pain scores, or other standard outcomes measures. As this data is observational in nature, it is difficult to draw firm conclusions as to the efficacy of the two blocks. However, since there are distinct known and described advantages associated with regional anesthetics for postoperative pain management, it would be prudent to evaluate these blocks in a controlled, randomized, trial. Prior to such a trial, a pilot study to evaluate the feasibility of such a trial is warranted.
As such, the investigators propose to evaluate the feasibility of investigating bilateral continuous erector spinae blocks (BESB) for patients undergoing surgical sternotomy by means of a pilot study. For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes. Secondary measures of feasibility will include aggregate 'data integrity' as defined by successful collection of 75% or greater of all possible data points for successfully completed subjects as well as 'efficient intervention duration' as evaluated by intervention completion time being less than 40 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single intervention group, bilateral erector spinae blocks with 0.2% ropivacaine, to assess the feasibility of this technique for postoperative pain control following surgeries involving sternotomies in children.
| Arm | Type | Receives |
|---|---|---|
| Bilateral erector spinae blocks | Experimental | Drug: RopivacaineBilateral erector spinae block catheters are placed at end of the sternotomy procedure, bolused with 1ml/kg 0.2% ropivacaine, then started on a 0.2ml/kg/hour continuous infusion of 0.2% ropivacaine. Patients will have access to rescue opiates as needed by means of the standard PCA/NCA demand protocols utilized at BCH. |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Scheduled as part of the cardiac surgical ERAS program.
- Scheduled for a primary sternotomy.
- Ages 3-21 years.
Key exclusion criteria (8 listed)
- Patients undergoing reoperative procedures.
- Significant scoliosis or other anatomic contraindications to ESB.
- History of bleeding or current therapeutic dose anticoagulant use.
- Significant intraoperative hemodynamic instability or bleeding, as ascertained by clinicians taking care of the patient.
- Patients with severe neurodevelopmental delays.
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 |
|---|---|---|
| RopivacaineAlso: NaropinErector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side. | Drug | Bilateral erector spinae blocks |
Primary outcome
Number of Participants Who Completed a Successful Intervention With No Major Adverse Events
Time frame: 48 hours
For this study, 'feasibility' will be defined primarily as a successful intervention completion rate of 75% or greater of all subjects with no major adverse outcomes.
1 secondary outcome
Number of Participants Who Completed a Successful Intervention With a Full Data Set
Time frame: 48 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
ROLAND BRUSSEAU, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ropivacaine in people with Pain, Postoperative, 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 8 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 5 Apr 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 5 Apr 2021). 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?
Number of Participants Who Completed a Successful Intervention With No Major Adverse Events (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Apr 2021.