NCT04153994 · Stanford University
Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients
What this study is about
Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects.
View original scientific description
Providing effective analgesia after spinal fusion for idiopathic scoliosis remains a challenge with significant practice variation existing among high volume spine surgery centers. Even in the era of multimodal analgesia, opioids are the primary analgesics used for pain control after pediatric scoliosis surgery, but have multiple known adverse effects. The erector spinae plane block (ESPB) is a newly described fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Additionally, there are case reports describing the ESPB as part of a multi-modal analgesic plan in adult degenerative spine surgery as well as adult spinal deformity surgery, demonstrating effective analgesia and no clinical motor blockade. Although it is known that the inflammatory reaction plays a crucial role in the mechanism of acute pain after major surgery, the effectiveness of the current regional approach on inflammatory response is not well studied.
Interventions
PROCEDURE
Erector Spinae Plane Blockade
The ESPB is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.
Primary outcome measures
Length of Stay (LOS)
Time frame: Through hospital stay, an average of 5 days
Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Postoperative Opioid Consumption
Time frame: Through hospital stay, an average of 5 days
Determine if bilateral surgical placed ESPBs will decrease postoperative opioid consumption measured in Morphine Milligram Equivalents (MME)
Maximum lidocaine plasma concentration [Cmax]
Time frame: Through hospital stay, an average of 5 days
Measure daily serial plasma lidocaine levels from ESPB catheters
Patient-Reported Pain Scores
Time frame: Through hospital stay, an average of 5 days
Patients will be asked on a daily basis by the research staff to report pain scores on a scale of 1-10 (1 signifying no pain to 10 signifying the worse pain).
Inpatient Postoperative Mobility
Time frame: Through hospital stay, an average of 5 days
Inpatient postoperative mobility will be tracked using activity tracker accelerometers and subsequently compared between the two groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosed with Idiopathic scoliosis
- Undergoing single-stage posterior spinal instrumentation and fusion
Exclusion criteria
- Thorascopic tethering procedure
- Two-stage procedure
- Abnormal developmental profile
- Congenital/neuromuscular scoliosis
- Requiring PICU admission
- Known allergy to lidocaine
- Known cardiac, renal or liver disease or dysfunction
- Pre-existing pain complaints, i.e. on regular analgesic medications
- Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria.
- Requiring non-standard post-op pain management
- Any history of seizures
- Unplanned staged procedure
- Weight \< 5th centile or \> 85th centile for age
Where
- Palo Alto, California
Related conditions & keywords
Frequently asked questions
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Data: ClinicalTrials.gov · synced May 1, 2025 · Source of record for eligibility and locations