Clinical trial NCT05944393: Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
Official title: Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scoliosis
Regional Anesthesia
Pediatric Anesthesia
Orthopedic Disorder of Spine
Keywords: erector spine plane block
neuromonitoring
pain management
multimodal analgesia
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: after being informed about the study and potential risks. All patients giving written consent will be randomized in a double-blind manner into 2 groups each one containing 25 patients, ESP group (n =25 ): The patients will receive Erector Spine Plane Block (ESP Block) after induction of general anesthesia.

Control group (n =25 ): The patients will receive a placebo block after induction of general anesthesia
Primary purpose: TREATMENT

Brief summary: Postoperative pain after scoliosis correction surgery is severe and usually requires long-term intravenous opioid therapy. Local anesthetic options are limited and include intrathecal opioids and epidural analgesia. However, they are rarely used due to side effects and inconsistent efficacy. The investigators describe an opioid-sparing multimodal analgesia regimen with bilateral erector spinae plane blocks.

Detailed description: Posterior spinal fusion for scoliosis correction is extremely painful and usually requires long-term, high-dose opioid use for adequate perioperative analgesia. Neuromonitoring, i.e., motor-evoked and somatosensory-evoked potentials (SSEPs), are the current gold standard for preventing neurological damage. Local anesthesia is essential to multimodal analgesia, but options are limited. Intrathecal or epidural opioid injections of local anesthetics have been reported but are rarely used due to logistical complexity, side effects, and inconsistent analgesic efficacy. The erector spinae plane (ESP) block was first described in 2016 for thoracic neuropathic pain. It is a new interfacial plane technique. Easy to perform on patients without spinal deformities. It was successfully used for surgery in adults. However, even with ultrasound guidance, identifying bone markers in scoliosis patients is challenging. The investigators will treat patients for scoliosis with single-shot bilateral ESP blocks. The investigators aim to provide effective perioperative pain control and achieve intraoperative hemodynamic stability without compromising neuromonitoring.

Eligibility criteria: Inclusion Criteria:

* Patients \< 18 years old undergoing scoliosis surgery

Exclusion Criteria:

* refusal to participate
* \> 18 yo
* Chronic opioid use
* localized infection

Primary outcomes:
measure: pain score
timeFrame: Within 30 minutes of emergence from anesthesia
measure: pain score - 60 minutes
timeFrame: Within 60 minutes of emergence from anesthesia
measure: pain score - 90 minutes
timeFrame: Within 90 minutes of emergence from anesthesia
measure: pain score - 120 minutes
timeFrame: Within 120 minutes of emergence from anesthesia
measure: pain score - 6 hours
timeFrame: Within 6 hours of emergence from anesthesia
measure: pain score - 12 hours
timeFrame: Within 12 hours of emergence from anesthesia
measure: pain score - 24 hours
timeFrame: Within 24 hours of emergence from anesthesia
measure: pain score - 48 hours
timeFrame: Within 48 hours of emergence from anesthesia
Secondary outcomes:
measure: total opioid consumption within first 24 hours
timeFrame: Second day following the procedure
measure: opioid consumption - 48 hours
timeFrame: Within 48 hours of emergence from anesthesia
measure: Nausea and Vomiting
timeFrame: Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly)
measure: NLR -12 hours
timeFrame: 12 hours postoperatively
measure: PLR -12 hours
timeFrame: 12 hours postoperatively
measure: NLR - 24 hours
timeFrame: 12 hours postoperatively
measure: PLR - 24 hours
timeFrame: 12 hours postoperatively
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
state: Wielkopolska
Study officials:
affiliation: Department of Palliative Medicine, University of Medical Sciences
name: Małgorzata Domagalska, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences
name: Tomasz Kotwicki, Profesor
role: STUDY_CHAIR
References: