NCT04153994 Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients
| NCT ID | NCT04153994 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Scoliosis; Juvenile |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-08-28 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-08-28 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * ASA I-III * 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 * Porphyria
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04153994 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Scoliosis; Juvenile. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04153994 currently recruiting?
Yes, NCT04153994 is actively recruiting participants. Contact the research team at bantsui@stanford.edu for enrollment information.
Where is the NCT04153994 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT04153994 clinical trial?
NCT04153994 is sponsored by Stanford University. The trial plans to enroll 50 participants.