Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||10 Years - 19 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Hospital for Special Surgery, New York|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Jordan Ruby, MD|
|Principal Investigator Affiliation||Hospital for Special Surgery, New York|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Enrolling by invitation|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Pain, Postoperative, Opioid Use, Recruitment|
Active Comparator: ESPB with Bupivacaine and Dexamethasone
12 pediatric spinal fusion surgery patients will be randomized to receive intraoperative ultrasound-guided bilateral ESPB with 0.25% bupivacaine with 2mg preservative free dexamethasone with a maximum of 30 mL total per side, depending on the patient's weight.
Placebo Comparator: No ESPB
12 pediatric spinal fusion surgery patients will be randomized to not receive an intraoperative ultrasound-guided bilateral ESPB. These patients will still receive the standard anesthesia regimen during and after surgery.
Procedure: - Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone
Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.
Other: - No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)
Patients who are randomized to this group will not receive a bilateral erector spinae plane block
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Hospital for Special Surgery (HSS)
New York, New York, 10021