← Back to Search

Corticosteroid

Steroid Injection for Post-Spinal Fusion Pain Management (SFSS Trial)

Q: Are there still vacancies available for potential participants in this research endeavor?

The findings on clinicaltrials.gov demonstrate that, as of March 9th 2022, this trial is not actively recruiting patients at the current moment in time. Although it was initially advertised on July 1st 20202, there are 33 other studies presently seeking participants.

Q: Are there any age restrictions for enrolment in this investigation?

Those who meet the criteria for participation, ages 10 to 18, will be eligible for one of 5 trials. Moreover, individuals over 65 are accepted into 29 different clinical studies.

Q: Is it possible for me to take part in this research project?

This medical research is welcoming patients aged between 10 and 18 who have the specified illness. Approximately 70 individuals are needed for this trial.

Phase < 1

Waitlist Available

Research Sponsored by University of Texas at Austin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets operative criteria for posterior spinal instrumented fusion for AIS

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SFSS Trial Summary

This trial is testing whether giving a person corticosteroids before surgery can help reduce pain and the need for opioids afterwards.

Who is the study for?

This trial is for children who need surgery for spine deformity and have their parents' consent. They must be having a first-time spinal fusion surgery, not a revision procedure, and shouldn't have other conditions that could affect recovery.Check my eligibility

What is being tested?

The study tests if giving dexamethasone (a steroid) intravenously during surgery can reduce pain and opioid use after the operation compared to saline (a placebo). It also looks at how quickly patients start walking again and how long they stay in the hospital.See study design

What are the potential side effects?

Dexamethasone may cause issues with wound healing or increase infection risk due to its effects on the body's metabolism and immune system. These side effects are particularly important to monitor following spine surgery.

SFSS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am eligible for spine surgery due to my scoliosis.

SFSS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Length of stay in hospital

Morphine equivalents use

Time to initial ambulation post-operatively and distance ambulated in first physical therapy session.

Secondary outcome measures

Pain score at discharge

Return to emergency department

Return to school

SFSS Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Steroid injectionActive Control1 Intervention

Dexamethasone will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs

Group II: Saline solutionPlacebo Group1 Intervention

Saline will be injected 1 dose intraoperatively, 3 doses post-operatively every 8hrs

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor

350 Previous Clinical Trials

80,914 Total Patients Enrolled

Media Library

Dexamethasone injection (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05287035 — Phase < 1

Spinal Fusion Research Study Groups: Steroid injection, Saline solution

Spinal Fusion Clinical Trial 2023: Dexamethasone injection Highlights & Side Effects. Trial Name: NCT05287035 — Phase < 1

Dexamethasone injection (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05287035 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for potential participants in this research endeavor?

"The findings on clinicaltrials.gov demonstrate that, as of March 9th 2022, this trial is not actively recruiting patients at the current moment in time. Although it was initially advertised on July 1st 20202, there are 33 other studies presently seeking participants."

Answered by AI

Are there any age restrictions for enrolment in this investigation?

"Those who meet the criteria for participation, ages 10 to 18, will be eligible for one of 5 trials. Moreover, individuals over 65 are accepted into 29 different clinical studies."

Answered by AI

Is it possible for me to take part in this research project?

"This medical research is welcoming patients aged between 10 and 18 who have the specified illness. Approximately 70 individuals are needed for this trial."

Answered by AI

Recent research and studies

Canadian Journal of Anesthesia/Journal canadien d'anesthésieJournal

Low-dose Ketorolac Improves Analgesia and Reduces Morphine Requirements Following Posterior Spinal Fusion in Adolescents

Munro, Hamish M., Sarah R. Walton, Shobha Malviya, Sandra Merkel, Terri Voepel-Lewis, Randall T. Loder, and Frances A. Farley. 2002. “Low-dose Ketorolac Improves Analgesia and Reduces Morphine Requirements Following Posterior Spinal Fusion in Adolescents”. Canadian Journal of Anesthesia/journal Canadien D'anesthésie. Springer Science and Business Media LLC. doi:10.1007/bf03017921.

SpineJournal

Peridural Methylprednisolone and Wound Infiltration with Bupivacaine for Postoperative Pain Control After Posterior Lumbar Spine Surgery

Jirarattanaphochai, Kitti, Surachai Jung, Somboon Thienthong, Wimonrat Krisanaprakornkit, and Chat Sumananont. 2007. “Peridural Methylprednisolone and Wound Infiltration with Bupivacaine for Postoperative Pain Control After Posterior Lumbar Spine Surgery”. Spine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.brs.0000257541.91728.a1.

Journal of Children's OrthopaedicsJournal

Clinical and Economic Implications of Early Discharge Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis

Fletcher, Nicholas D., Nader Shourbaji, Phillip M. Mitchell, Timothy S. Oswald, Dennis P. Devito, and Robert W. Bruce. 2014. “Clinical and Economic Implications of Early Discharge Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis”. Journal of Children's Orthopaedics. SAGE Publications. doi:10.1007/s11832-014-0587-y.

British Journal of AnaesthesiaJournal