Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients (NCT04153994) | Clinical Trial Compass
RecruitingNot Applicable
Erector Spinae Plane Blockade in Pediatric Scoliosis Surgery Patients
United States50 participantsStarted 2020-08-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Length of Stay (LOS)
Timeframe: Through hospital stay, an average of 5 days
2
Postoperative Opioid Consumption
Timeframe: Through hospital stay, an average of 5 days
3
Maximum lidocaine plasma concentration [Cmax]
Timeframe: Through hospital stay, an average of 5 days
4
Patient-Reported Pain Scores
Timeframe: Through hospital stay, an average of 5 days
5
Inpatient Postoperative Mobility
Timeframe: Through hospital stay, an average of 5 days