Erector Spine Plane (ESP) Block for Analgesia in Pediatric Scoliosis Surgery
- Conditions
- Orthopedic Disorder of SpineRegional AnesthesiaScoliosisPediatric Anesthesia
- Interventions
- Drug: Normal saline 0.9% Injectable Solution
- Registration Number
- NCT05944393
- Lead Sponsor
- Poznan University of Medical Sciences
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Patients < 18 years old undergoing scoliosis surgery
- refusal to participate
- > 18 yo
- Chronic opioid use
- localized infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESB block Ropivacaine 0.2% Injectable Solution Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0.2% ropivacaine per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,2% Ropivacaine. The needle is withdrawn, and the needle entry site is wiped clean. Placebo block Normal saline 0.9% Injectable Solution Patients will receive preoperative ultrasound-guided bilateral single-injection ESP blocks at one or two levels before incision with 10 mL 0,9% normal saline per single injection. Using appropriate sterile precautions, under general anesthesia, an ultrasound (Mindrey TE9) equipped with either a linear 15-6 megahertz (MHz), or a curvilinear 5-2 MHz transducer (habitus-dependent) used to identify the erector spine, transverse process, and paravertebral space. A 22G 0,7x80 mm echogenic block needle (Stimuplex Ultra 360)) is inserted in-plane from the cranial to caudal direction until the needle tip contacts the transverse process. 1-3mL is injected to confirm the proper injection plane by visualizing the spread deep to the erector spinae muscles and superficial to the transverse process. Block is completed with 10mL of 0,9% normal saline. The needle is withdrawn, and the needle entry site is wiped clean.
- Primary Outcome Measures
Name Time Method 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 Within 30 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 - 24 hours Within 24 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 - 48 hours Within 48 hours 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 - 120 minutes Within 120 minutes of emergence from anesthesia NRS (numerical rating scale) score (0- no pain to 10 worst pain)
- Secondary Outcome Measures
Name Time Method PLR - 24 hours 12 hours postoperatively platelet/limphocyte ratio
NLR -12 hours 12 hours postoperatively neutrophil/limphocyte ratio
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.
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.
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.
PLR -12 hours 12 hours postoperatively platelet/limphocyte ratio
NLR - 24 hours 12 hours postoperatively neutrophil/limphocyte ratio
Trial Locations
- Locations (1)
Department of Spine Diseases and Pediatric Orthopedics, University of Medical Sciences, Poznań, Poland
🇵🇱Poznań, Wielkopolska, Poland