Perioperative Use of Erector Spinae Plane Block (ESPB) and Intravenous Lidocaine Infusion in Anesthetic Management of Spinal Surgery in Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Interventions for congenital or acquired spinal anomalies are usually voluminous and traumatic, which causes a high level of pain stimulation during the perioperative period. Thus, the problem of pain in spinal surgery is extremely important and is one of the main components of successful treatment.
Combined anesthesia using regional techniques (local anesthesia is added to general anesthesia) can be a significant alternative to performing traditional combined anesthesia with high doses of opioids (narcotic painkillers with undesirable side effects). It allows you to follow the principles of multimodal analgesia, with the possibility of rapid recovery of the patient in the postoperative period.
The use of ESPB (spinal straightening plane blockade) in vertebrology has currently been studied only in adult patients. ESPB is effective and safe for postoperative pain relief after lumbar spine surgery. ESPB can reduce the consumption of opioids (narcotic painkillers) after surgery, increase patient satisfaction, and shorten the length of hospitalization.
Currently, the use of the local anesthetic lidocaine as a medicinal agent for intravenous infusion in children, as an alternative to narcotic anesthesia, is also being actively discussed.
A large number of studies indicate the effectiveness of intravenous lidocaine infusion for perioperative anesthesia in adult patients. In pediatric practice, this technique is not widely used due to the lack of evidence base for efficacy and safety.
Intravenous infusion of lidocaine consistently improves analgesic parameters in the adult and pediatric populations in the first 24 hours, while an effective decrease in the consumption of narcotic painkillers is noted by 48 hours.
Intravenous lidocaine has demonstrated antineuropathic, antihyperalgesic and anti-inflammatory effects and is a new method. Numerous studies in adults have demonstrated the beneficial effects of intravenous lidocaine, including improved pain relief with reduced postoperative use of narcotic painkillers, earlier activation, and shorter length of stay in the intensive care unit. To date, the dose ranges studied in the pediatric population have not been associated with serious side effects, and current evidence suggests that intravenous lidocaine administration will be well tolerated.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Sankt-Peterburg
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Saint Petersburg, Sankt-Peterburg, Russia, 190121
- SaintPetersburgSU
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1. Elective surgery on the thoracic and lumbosacral spine. 2. Signed informed consent to participate in the study; 3. Age 3-17 years.
Exclusion Criteria:
- Contraindications to the use of local anesthetics;
- Operations on the cervical spine;
- Contraindications to performing ESPB;
- The patient's refusal to participate in the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Blockade of the plane straightening the spine (Erector Spinae Plane Block, ESPB).
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The patient will undergo an ESP blockade under the control of ultrasound during the implementation of anesthetic support.
A local anesthetic will be injected into the fascial space of the muscles straightening the spine: ropivacaine 0.375%, 3 mg / kg, on both sides.
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Active Comparator: IV Lidocaine
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During the implementation of anesthetic support, the patient will receive a constant intravenous infusion of lidocaine: a loading dose of 1.5 mg/kg/ h (1 hour), followed by an infusion of 1 mg/kg/h for 24 hours during the perioperative period.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time before emergency pain relief (opioid).
Time Frame: 24 hours postoperatively
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Time before emergency pain relief (opioid).
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24 hours postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the need for opioids in the postoperative period within 24 hours
Time Frame: 24 hours
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the need for opioids in the postoperative period within 24 hours (of the start of anesthesia)
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24 hours
|
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assessment of intraoperative analgesia quality (pulse)
Time Frame: during surgery
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pulse monitoring during surgery
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during surgery
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assessment of intraoperative analgesia quality (BP)
Time Frame: during surgery
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Blood pressure monitoring during surgery
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during surgery
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Complications associated with intravenous lidocaine infusion (general toxic effects on the cardiovascular and central nervous systems)
Time Frame: 24 hours
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24 hours
|
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Complications associated with spinal straightening plane block (ESPB)
Time Frame: 24 hours
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Complications: neurological, bleeding, hematoma, infection.
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24 hours
|
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pain level assessment using pain scales (Wong-Baker Faces Pain Rating Scale)
Time Frame: 24 hours postoperatively
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use Wong-Baker Faces Pain Rating Scale (postoperative period) The Wong-Baker Faces Pain Rating Scale is used for general assessment of pain intensity in adult patients and children over 3 years of age. The scale consists of 6 faces, ranging from laughing (no pain) to crying (unbearable pain). Each face corresponds to a certain number of points: 0 points - a happy smiling face, means no pain (No Hurt); 2 points - a slight smile on the face, means slight soreness (Hurts Little Bit); 4 points - neutral facial expression, means slight pain (Hurts Little More); 6 points - facial expression with slightly furrowed eyebrows, means average pain (Hurts Even More); 8 points - a facial expression with heavily furrowed eyebrows means severe pain (Hurts a Whole Lot); 10 points - a crying, unhappy expression means excessive unbearable pain (Hurts Worst). |
24 hours postoperatively
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Collaborators and Investigators
Investigators
- Principal Investigator: Maxim Sergeevich Monastirniy, Saint Petersburg State University, Russia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SaintPetersburgSU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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