Continuous Erector Spinae Block Versus Continuous Paravertebral Block Following Thoracotomy: A Randomized, Controlled Non-Inferiority Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Boston Children's Hospital
- Enrollment
- 34
- Locations
- 2
- Primary Endpoint
- Rescue analgesic consumption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Month to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
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.
Intervention: Ropivacaine (Drug)
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.
Intervention: continuous erector spinae block (ESB) (Procedure)
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.
Intervention: continuous paravertebral block (PVB) (Procedure)
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.
Intervention: Ropivacaine (Drug)
Outcomes
Primary Outcomes
Rescue analgesic consumption
Time Frame: 24 hours
rescue opiates (rendered as morphine equivalents/kg) given by blinded providers using standard PCA/NCA demand protocols
Secondary Outcomes
- Time to perform the block in the operating room(1 hour)
- Pain scores(24, 48 and 72 hours)
- Rescue analgesic consumption(72 hours)
- Number of Adverse events(1 week)
Investigators
Roland Brusseau
Associate in Perioperative Anesthesia, Department of Anesthesiology, Perioperative and Pain Medicine Instructor in Anaesthesia, Havard Medical School
Boston Children's Hospital