Steroid Injection for Post-Spinal Fusion Pain Management

(SFSS Trial)

Overseen By Brian M Kaufman

Age: < 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Texas at Austin

Disqualifiers: Revision procedure, other conditions, others

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Dexamethasone injection for post-spinal fusion pain management?

Research shows that Dexamethasone can help reduce pain and the need for painkillers after spine surgeries, like lumbar disc surgery, and may also speed up recovery without causing wound-healing problems. ^{1 2 3 4 5}

Is dexamethasone injection safe for humans?

Dexamethasone injections have been studied for safety in various conditions, including spine surgeries, and are generally considered safe when used appropriately. However, there is a risk of serious spinal adverse events with epidural corticosteroid injections, so it's important to discuss potential risks with your doctor. ^{1 2 6 7 8}

How does the drug Dexamethasone differ from other treatments for post-spinal fusion pain management?

Dexamethasone is unique because it is a high-potency, long-acting steroid that provides strong anti-inflammatory and analgesic (pain-relieving) effects, which can reduce the need for opioids and their side effects. It can be administered in various ways, such as intravenously or epidurally, and has been shown to improve postoperative pain control and recovery in spine surgeries. ^{1 2 5 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

Parental consent

I am eligible for spine surgery due to my scoliosis.

Exclusion Criteria

I have other health conditions that could affect my recovery after surgery.

I am undergoing a revision procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Perioperative Treatment

Dexamethasone or saline is administered intraoperatively and post-operatively to manage pain and reduce opioid use

1 week

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain scores and morphine equivalent use

1 week

In-hospital monitoring

Extended Follow-up

Participants are tracked for return to emergency department and return to school

12 months

Treatment Details

Interventions

• Dexamethasone injection

Trial Overview 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.

Participant Groups

Group I: Steroid injection Active Control 1 Intervention

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

Group II: Saline solution Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

Findings from Research

In a study of 80 patients undergoing lumbar spine surgery, a single dose of dexamethasone significantly reduced total post-operative morphine consumption within 48 hours compared to a placebo, indicating its potential as an effective adjunct for pain management.

Despite the reduction in morphine use, dexamethasone did not significantly affect pain scores at rest or during movement, suggesting that while it may help lower opioid requirements, it does not enhance overall pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intermediate dose dexamethasone on post-operative pain in lumbar spine surgery: A randomized, triple-blind, placebo-controlled trial. Wittayapairoj, A., Wittayapairoj, K., Kulawong, A., et al.[2018]

A short course of postoperative dexamethasone after posterior spinal fusion for adolescent idiopathic scoliosis significantly reduced opioid usage by 39.6% without increasing the risk of wound complications, as shown in a study of 113 patients from 2015 to 2018.

Patients receiving steroids were also more likely to walk during their initial physical therapy evaluation, indicating improved recovery outcomes compared to those who did not receive steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. Fletcher, ND., Ruska, T., Austin, TM., et al.[2021]

In a study of 90 patients undergoing major abdominal surgery, administering 5 mg of epidural dexamethasone either before or after the operation significantly reduced postoperative pain and the need for rescue analgesics compared to a control group without dexamethasone.

While there were no significant differences in nausea and vomiting among the groups, patients receiving dexamethasone at the end of the operation reported more frequent itching, indicating a potential side effect to consider.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of epidural administration of dexamethasone on postoperative pain: a randomized controlled study in radical subtotal gastrectomy. Jo, YY., Yoo, JH., Kim, HJ., et al.[2022]

In a study of 600 patients receiving epidural steroid injections, both dexamethasone and betamethasone showed similar effectiveness in pain relief at 2 weeks, with around 33% of patients reporting significant improvement.

However, betamethasone was associated with fewer adverse events and greater reductions in pain and disability scores compared to dexamethasone, making it the preferred choice for epidural steroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy and safety of epidural steroid injection using a nonparticulate steroid, dexamethasone or betamethasone: a double-blind, randomized, crossover, clinical trial. Lee, GY., Lee, JW., Lee, E., et al.[2022]

In a study of over 1.3 million epidural corticosteroid injections (ESIs) from 2009 to 2015, the rate of serious spinal adverse events (SSAEs) was found to be low at 8.1 per 1,000,000 patients.

Cervical and thoracic ESIs were associated with a significantly higher risk of SSAEs (29.4 per 1,000,000) compared to lumbar and sacral injections (5.1 per 1,000,000), while the risk was similar across different corticosteroid formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population. Eworuke, E., Crisafi, L., Liao, J., et al.[2022]

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Effect of intermediate dose dexamethasone on post-operative pain in lumbar spine surgery: A randomized, triple-blind, placebo-controlled trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Postoperative Dexamethasone Following Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis. [2021]

3. China pubmed.ncbi.nlm.nih.gov

Limited post-operative dexamethasone use does not affect lumbar fusion: a single institutional experience. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The use of dexamethasone in primary lumbar disc surgery. A prospective, randomized, double-blind study. [2022]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

The effect of epidural administration of dexamethasone on postoperative pain: a randomized controlled study in radical subtotal gastrectomy. [2022]

6. Korea (South) pubmed.ncbi.nlm.nih.gov

Evaluation of the efficacy and safety of epidural steroid injection using a nonparticulate steroid, dexamethasone or betamethasone: a double-blind, randomized, crossover, clinical trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Risk of serious spinal adverse events associated with epidural corticosteroid injections in the Medicare population. [2022]

8. India pubmed.ncbi.nlm.nih.gov

The Effect of Intravenous Dexamethasone on Intraoperative and Early Postoperative Pain in Lumbar Spine Surgery: A Randomized Double-Blind Placebo-Controlled Study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Intraoperative Administration of Dexmedetomidine and Dexamethasone in Local Anesthetic Infiltration to Improve Postoperative Pain Control After Posterior Cervical Fusion. [2021]