Scoliosis, Regional Anesthesia, Pediatric Anesthesia, Orthopedic Disorder of Spine
Conditions
Keywords
erector spine plane block, neuromonitoring, pain management, multimodal analgesia
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.
Interventions
DRUGRopivacaine 0.2% Injectable Solution
Ultrasound-guided Erector Spine Plane block with 10 mL 0.5% ropivacaine
Ultrasound-guided Erector Spine Plane block with 10 mL 0.9% normal saline
Sponsors
Poznan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Subjects will be randomized to one of two groups with a computer-generated arm assignment. The sealed envelopes will be opened immediately prior to nerve block. One group will receive a ESP block and the other will receive a placebo block. The provider performing the block will not be blinded, however all other members of the care team, the patient, and the investigator collecting data will be blinded to the randomization.
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
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patients \< 18 years old undergoing scoliosis surgery
Exclusion criteria
* refusal to participate * \> 18 yo * Chronic opioid use * localized infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain score - 48 hours | Within 48 hours of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
| pain score | Within 30 minutes of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
| pain score - 60 minutes | Within 60 minutes of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
| pain score - 90 minutes | Within 90 minutes of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
| pain score - 120 minutes | Within 120 minutes of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
| pain score - 6 hours | Within 6 hours of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
| pain score - 12 hours | Within 12 hours of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
| pain score - 24 hours | Within 24 hours of emergence from anesthesia | NRS (numerical rating scale) score (0- no pain to 10 worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| opioid consumption - 48 hours | Within 48 hours of emergence from anesthesia | Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is \<4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record. |
| Nausea and Vomiting | Beginning with emergence from anesthesia and ending with discharge from the post-anesthesia care unit (0-48 hours postoperativly) | This is a yes/no binary outcome measure defined by administration of any antiemetic drug in the post-anesthesia care unit. |
| NLR -12 hours | 12 hours postoperatively | neutrophil/limphocyte ratio |
| PLR -12 hours | 12 hours postoperatively | platelet/limphocyte ratio |
| NLR - 24 hours | 12 hours postoperatively | neutrophil/limphocyte ratio |
| PLR - 24 hours | 12 hours postoperatively | platelet/limphocyte ratio |
| total opioid consumption within first 24 hours | Second day following the procedure | Total morphine milligram equivalents required by patients in the post-anesthesia care unit, prior to discharge from the outpatient surgery center. Following emergence from anesthesia, pain will be assessed in regular intervals, with administration of IV and oral opioids according to numeric rating scale and clinical assessment. Opioid administration stops when patient numerical rating score is \<4, when patient endorses manageable pain level, when side effects of opioids are intolerable, or for other concerning clinical conditions as determined by the anesthesiologist of record. |
Countries
Poland
Contacts
Primary ContactMałgorzata Domagalska, PhD
Backup ContactMałgorzata Domagalska
Outcome results
None listed