SaintPetersburgSU
Saint Petersburg, Sankt-Peterburg, 190121, Russia
NCT Number: NCT06965933
Testing the hypothesis that in children undergoing spinal surgery, ESP-block will increase the time to emergency anesthesia in the postoperative period compared with intravenous lidocaine infusion.
This study is active but is not currently recruiting participants.
Notify Me3 year–17 year
All sexes
Interventional
Phase 4
Saint Petersburg, Sankt-Peterburg, 190121, Russia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 24 hours postoperatively
Time before emergency pain relief (opioid).
Time frame: 24 hours
the need for opioids in the postoperative period within 24 hours (of the start of anesthesia)
Time frame: 24 hours postoperatively
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).
Time frame: during surgery
pulse monitoring during surgery
Time frame: during surgery
Blood pressure monitoring during surgery
Time frame: 24 hours
Time frame: 24 hours
Complications: neurological, bleeding, hematoma, infection.
Saint Petersburg State University, Russia
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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