Spinal Fusions Steroid Study (SFSS)

The University of Texas System (UT)

Status and phase: Invitation-only; Early Phase 1

Conditions: Spinal Fusion

Treatments: Other: Saline injection; Drug: Dexamethasone injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05287035

STUDY00002340

Details and patient eligibility

About

Current efforts to improve pain alleviation focus on non-opioid pharmaceuticals. Intravenous perioperative corticosteroid administration has been suggested as an alternative method for post-operative pain control. The evidence regarding perioperative intravenous corticosteroids to help alleviate post-operative pain is mixed. Some meta-analyses report decreased opioid consumption and decreased pain intensity after a variety of surgical procedures. However, a study of larger orthopedic procedures found no benefit. The catabolic and immunosuppressant effects of corticosteroids also pose issues with wound healing and infection, which can have severe consequences after spine surgery. There is limited data on the effect of perioperative intravenous steroid administration on pain alleviation in children having surgery to address spine deformity. A recent retrospective review demonstrated that perioperative corticosteroid administration was associated with a statistically significant decrease in opioid medication utilization among children and adolescents after spinal deformity surgery. While not increasing the risk of postoperative complications. The investigators hypothesize that the administration of perioperative intravenous dexamethasone will demonstrate a clinically meaningful and statistically significant decrease in postoperative pain intensity, need for opioid medications, time to ambulation, and length of stay in children recovering from surgery for spine deformity.

Enrollment: 70 estimated patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meets operative criteria for posterior spinal instrumented fusion for AIS
• Parental consent

Exclusion criteria

• Revision procedure
• Other associated conditions which may alter the postoperative course

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Steroid injection

Active Comparator group

Description:

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

Treatment:

Drug: Dexamethasone injection

Saline solution

Placebo Comparator group

Description:

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

Treatment:

Other: Saline injection