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Continuous Erector Spinae Block Versus Continuous Paravertebral Block

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ClinicalTrials.gov Identifier: NCT03768440
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Roland Brusseau, Boston Children’s Hospital

Tracking Information
First Submitted Date  ICMJE November 16, 2018
First Posted Date  ICMJE December 7, 2018
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE April 16, 2019
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Rescue analgesic consumption [ Time Frame: 24 hours ]
rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03768440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2018)
  • Pain scores [ Time Frame: 24, 48 and 72 hours ]
    Pain scores measured by the numeric rating scale (NRS: 0/none -> 10/worst)
  • Time to perform the block in the operating room [ Time Frame: 1 hour ]
    Total time required for intervention
  • Number of Adverse events [ Time Frame: 1 week ]
    Any intervention related (or unrelated) adverse events
  • Rescue analgesic consumption [ Time Frame: 48 hours ]
    rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
  • Rescue analgesic consumption [ Time Frame: 72 hours ]
    rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
  • Pain scores [ Time Frame: 24, 48 and 72 hours ]
    Pain scores measured by the numeric rating scale (NRS: 0/none -> 10/worst)
  • Time to perform the block in the operating room [ Time Frame: 1 hour ]
    Total time required for intervention
  • Adverse events [ Time Frame: 1 week ]
    Any intervention related (or unrelated) adverse events
  • Rescue analgesic consumption [ Time Frame: 48 hours ]
    rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
  • Rescue analgesic consumption [ Time Frame: 72 hours ]
    rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Erector Spinae Block Versus Continuous Paravertebral Block
Official Title  ICMJE Continuous Erector Spinae Block Versus Continuous Paravertebral Block Following Thoracotomy: A Randomized, Controlled Non-Inferiority Study
Brief Summary

Overall Aim: To evaluate the efficacy of continuous erector spinae block (ESB) versus continuous paravertebral block (PVB) for postoperative analgesia in children and adolescents undergoing surgical procedures via unilateral thoracotomy.

Hypothesis: The investigators hypothesize that ESP block efficacy is not inferior to that of PVB with respect to pain control and consumed opiate equivalents at 24 hours postoperatively.

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 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.

Given the rapid evolution of the field of regional anesthesia and the fact that there are often multiple approaches for achieving analgesia in a select set of dermatomes, there are often a variety of regional anesthetic options for any given surgery. Some approaches are longstanding and well-studied, but with increasing frequency since the advent of ultrasound guidance, newer, novel nerve block options exist. As it is often expensive and work-intensive to thoroughly evaluate a given regional technique with a controlled pediatric trial, many of these blocks become standards of practice based on anecdote, retrospective analysis, or simply belief in the putative benefits of regional anesthetics.

The investigators are fortunate at BCH to have one of the largest concentrated pediatric surgical populations in the US. They also have 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 anesthesia in children. Furthermore, the investigators feel it is 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 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 (when used bilaterally) for management of post-sternotomy pain.

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 patients as opposed to neuraxial (e.g. epidural) and paraneuraxial (i.e. paravertebral) nerve blocks.

Given the ESB's potentially favorable risk profile versus the other blocks (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. It also offers a new option for a subset of anticoagulated patients for whom other regional techniques (epidural, paravertebral) are contraindicated.

Indeed, given the current information available related to the ESB, the regional anesthesia service at BCH has begun employing it when possible in circumstances where a PVB would commonly be used but is relatively or absolutely contraindicated. Patients undergoing thoracotomies while anticoagulated for cardiopulmonary bypass, aortic clamping, etc. have been successfully managed with 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 47 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 comparative efficacy of the two blocks. However, since there are differences in technical difficulty, relative contraindications, and there exist populations that might benefit from these blocks, it would be prudent to comparatively evaluate these blocks in a controlled, randomized, trial.

The investigators propose to evaluate the comparative efficacy of ESBs and PVBs for patients undergoing unilateral non-cardiac thoracotomy by means of a randomized, controlled non-inferiority study (based on a threshold of clinical significance being defined as a 15% difference) comparing rescue analgesic requirements, rendered as opiate equivalents, at 24 postoperatively. Rescue opiates will be available as needed by means of standard PCA/NCA demand protocols. Secondary measures will include rescue opiate requirements at 48 and 72 hours, pain scores, adverse events, time to discharge from the ICU, time to extubation, patient disposition after surgery, and time to perform the block in the operating room.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain, Postoperative
Intervention  ICMJE
  • Procedure: continuous erector spinae block (ESB)
    Erector spinae block: 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.
    Other Names:
    • ESB with ropivacaine
    • Naropin
  • Procedure: continuous paravertebral block (PVB)
    The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward 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.
    Other Names:
    • PVB with ropivacaine
    • Naropin
  • Drug: Ropivacaine
    Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
    Other Name: Naropin
Study Arms  ICMJE
  • Experimental: continuous erector spinae block
    An erector spinae block is placed at end of the thoracotomy 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. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
    Interventions:
    • Procedure: continuous erector spinae block (ESB)
    • Drug: Ropivacaine
  • Active Comparator: continuous paravertebral block
    A paravertebral block is placed at end of the thoracotomy 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. Rescue analgesic consumption will be tabulated at 24, 48 and 72 hours, rendered as total opiate equivalents.
    Interventions:
    • Procedure: continuous paravertebral block (PVB)
    • Drug: Ropivacaine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date January 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I - III status, undergoing unilateral thoracotomy for either esophageal atresia related intrathoracic procedures or other non-cardiac general surgical intrathoracic procedures.

Exclusion Criteria:

  • Patients undergoing procedures including pleurodesis, pleural stripping, and decortication or other procedures with widely distributed pleural disruption.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: ROLAND BRUSSEAU, MD 8572184814 roland.brusseau@childrens.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03768440
Other Study ID Numbers  ICMJE IRB-P00030317
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Roland Brusseau, Boston Children’s Hospital
Study Sponsor  ICMJE Boston Children’s Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ROLAND BRUSSEAU, MD Boston Children’s Hospital
PRS Account Boston Children’s Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP