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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a steroid injection called dexamethasone can reduce pain and the need for opioid medications after spinal surgery in children with spine deformity. The study aims to determine if this treatment eases recovery by decreasing pain, speeding up walking after surgery, and shortening hospital stays. Participants will receive either the steroid injection or a placebo (a harmless saline solution) for comparison. Children undergoing their first spinal fusion surgery for scoliosis (a spine curve) may qualify for this trial, provided there is parental consent. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking medical knowledge.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that administering dexamethasone through an IV can help reduce pain after surgery. Some studies suggest it can also lower the need for opioids, which are addictive pain medications. For instance, a review of several studies found that a moderate dose of dexamethasone led to less opioid use and reduced pain after surgery. Another study found that dexamethasone improved pain relief after spinal anesthesia.

However, the results are not always positive. In larger surgeries, dexamethasone did not consistently reduce the need for pain medication. Concerns exist about its impact on wound healing and the risk of infection, especially in spine surgeries. Yet, in children and teens undergoing surgery for spine deformities, dexamethasone was linked to reduced opioid use without increasing the risk of complications.

This trial is in the early testing stages, so limited information is available on its safety for this specific use. However, dexamethasone is already used for other conditions, suggesting it is generally well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for post-spinal fusion pain typically involve oral medications like opioids or NSAIDs. Dexamethasone injection is unique because it delivers a targeted steroid directly to the surgical site, potentially reducing inflammation more effectively than systemic medications. This local delivery method could mean quicker pain relief with fewer side effects. Researchers are excited about this treatment as it offers a promising alternative that can enhance recovery and improve patient comfort following spinal fusion surgery.

What evidence suggests that this treatment might be an effective treatment for post-spinal fusion pain?

Research has shown that administering dexamethasone through an IV can reduce pain after surgery. In one study, 74.8% of patients who received dexamethasone rated their pain relief as "Excellent" following spinal surgery. Another study found that dexamethasone significantly reduces the need for opioids and lowers pain levels post-surgery. However, concerns exist about side effects, such as wound healing issues and an increased risk of infection. Despite these concerns, early evidence suggests that dexamethasone might ease post-surgery pain and facilitate smoother recovery. In this trial, participants will receive either a steroid injection with dexamethasone or a placebo comparator with saline solution to evaluate the effectiveness and safety of dexamethasone for managing post-spinal fusion pain. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6319081/

The Effect of Intravenous Dexamethasone on ... We conclude that preoperative iv dexamethasone (single dose) is effective in reducing intraoperative pain and maintaining good analgesia in early postoperative ...

2. journals.lww.com journals.lww.com/atmr/fulltext/2024/01000/dexamethasone_in_post_spinal_surgery_recovery__a.25.aspx

Dexamethasone in Post-spinal Surgery Recovery: A Saudi... Notably, 74.8% of participants who received dexamethasone rated the effectiveness of pain management during their recovery as 'Excellent'. The study found a ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12543256/

The Effect of Dexamethasone Administration on ... Injection of 8 mg of dexamethasone before propofol injection significantly reduces the intensity and incidence of pain during propofol injection ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468824X17300517

Effect of intermediate dose dexamethasone on post ... A previous meta-analysis revealed that an intermediate dose (0.1–0.2 mg/kg) of dexamethasone significantly decreases post-operative opioid consumption and pain ...

5. journals.lww.com journals.lww.com/painrpts/fulltext/2022/06000/postoperative_pain_treatment_after_spinal_fusion.8.aspx

Postoperative pain treatment after spinal fusion surgery The results showed a significant reduction in opioid consumption for treatment with NSAID (P < 0.0008) and epidural (P < 0.0006) (predefined minimal clinical ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26213843/

A Controlled Cohort Study of Efficacy and Safety Systemic dexamethasone after 1- and 2-level lumbar fusion surgery demonstrated minimal impact on 48 hours perioperative narcotics use with no detriment to pain ...

7. journals.lww.com journals.lww.com/adbm/fulltext/2025/09270/the_effect_of_dexamethasone_administration_on.109.aspx

The Effect of Dexamethasone Administration on ... Many studies have reported the positive effect of dexamethasone to manage pain, nausea, and vomiting after tonsil, ear, gall bladder, genital surgery, ...

8. associationofanaesthetists-publications.onlinelibrary.wiley.com associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/abs/10.1111/anae.14666

Effect of intravenous dexamethasone on postoperative pain ... We report a high level of evidence that intravenous dexamethasone improves postoperative analgesia after spinal anaesthesia.