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NCT04153994 · ClinicalTrials.gov registry record · NA
Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients
A NA study of Scoliosis; Adolescence and Scoliosis; Juvenile, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT04153994: Recruiting NA study of Scoliosis; Adolescence and Scoliosis; Juvenile, sponsored by Stanford University.
NCT04153994 is a NA study of Scoliosis; Adolescence and Scoliosis; Juvenile that is actively recruiting participants, run by Stanford University. The registered enrollment target is 50 participants, below the 1,116-participant average among 6 other Scoliosis; Adolescence trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04153994, a NA study of Scoliosis; Adolescence and Scoliosis; Juvenile, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Determine if bilateral surgical placed ESPBs will decrease length of stay in the pediatric ICU and the hospital. LOS and decrease postoperative opioid consumption.)
Conditions Studied
Interventions
- PROCEDURE Erector Spinae Plane Blockade
Study Locations (1)
California
- Lucille Packard Children's Hospital - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2025-12 |
| Phase | NA |
What NCT04153994 shows while recruiting
NCT04153994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,116-participant average among 6 other Scoliosis; Adolescence trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Scoliosis; Adolescence appearing as the primary indexed condition, and to 1 intervention - of which Erector Spinae Plane Blockade is the first listed.
NCT04153994 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04153994 about?
NCT04153994 is a clinical study titled "Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients". 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 scoli...
What is the current status of trial NCT04153994?
This trial is currently recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2020-08-28. Estimated completion is 2025-12.
What conditions does trial NCT04153994 study?
This clinical trial studies the following conditions: Scoliosis; Adolescence, Scoliosis; Juvenile.
What interventions are being tested in trial NCT04153994?
The interventions under investigation include: Erector Spinae Plane Blockade (PROCEDURE).
Who is sponsoring clinical trial NCT04153994?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04153994 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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