Depo-Medrol for Postoperative Pain

Overseen By Study Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hardeep Singh

Must not be taking: Chronic oral steroids

Disqualifiers: Scoliosis, Spondylolisthesis, Diabetes, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the steroid Depo-Medrol (methylprednisolone acetate) affects pain and muscle weakness after a specific type of back surgery. Researchers aim to determine if injecting this medication into a muscle near the spine can alleviate hip flexor weakness and reduce pain and numbness in the thigh. Participants will receive either the steroid treatment or a placebo (inactive substance) along with standard care. The trial seeks patients who have undergone a specific type of back surgery involving L3-4 or L4-5 disc work and have lumbar disc degeneration. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment can benefit more patients.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are a chronic oral steroid user, you cannot participate in the trial.

What is the safety track record for Depo-Medrol?

Research has shown that Depo-Medrol, a corticosteroid, can help manage post-surgical pain. One study found that injections of its main ingredient, methylprednisolone, significantly reduced the frequency and intensity of pain after surgery. Another study found that using methylprednisolone did not increase the risk of infections at the surgery site for some procedures.

However, corticosteroids like Depo-Medrol can cause side effects. Common issues include higher blood sugar levels, and in rare cases, joint problems such as swelling or fever.

Since this trial is in a later stage, more information is usually available about the treatment's safety. The FDA has approved Depo-Medrol for other uses, indicating it is well-understood and generally safe. Always consult a doctor to understand the risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for postoperative pain, which typically involves oral or injectable pain medications like opioids and NSAIDs, Depo-Medrol is administered directly at the surgical site in a gel form. This unique delivery method allows for a targeted, sustained release of the active ingredient, methylprednisolone, potentially reducing inflammation more effectively. Researchers are excited about this approach because it might offer longer-lasting pain relief with fewer systemic side effects compared to traditional options.

What is the effectiveness track record for Depo-Medrol in treating postoperative pain?

Research has shown that Depo-Medrol, a type of steroid, can help reduce pain after surgery. One study with patients who had back surgery found that using methylprednisolone acetate, a form of Depo-Medrol, led to a 37% shorter hospital stay. Another study found that applying a small amount of Depo-Medrol directly to the area effectively reduced immediate back pain after surgery. In this trial, participants in the test group will receive standard care plus the study intervention, which includes Depo-Medrol, to evaluate its effectiveness in easing pain and improving recovery after surgery. ^{1 3 6 7 8}

Who Is on the Research Team?

Hardeep Singh, M.D.

Principal Investigator

UConn Health

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with lumbar disc degeneration who are undergoing a specific back surgery (LLIF) involving the L3-4 and/or L4-5 spinal levels. Candidates must not have severe spine curvature, advanced spondylolisthesis, flatback deformity, diabetes requiring insulin, or be chronic oral steroid users. They also can't have allergies to steroids like Depo-Medrol.

Inclusion Criteria

Patients from the practices of Drs. Singh, Mallozzi, Moss

Patients who agree to be a part of the study

I have degeneration in my lumbar disc.

Exclusion Criteria

I am not fluent in English.

My spine condition is more severe than a mild slip.

I need surgery on both sides of my spine through the psoas muscle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a Depo-Medrol injection or placebo following transpsoas lateral lumbar interbody fusion (LLIF) surgery

12 weeks

3 visits (in-person) at 2-3, 6, and 12 weeks post-surgery

Follow-up

Participants are monitored for safety and effectiveness, including assessments of thigh pain, hip flexor weakness, and numbness

2 years

Multiple visits (in-person) at 6 months, 1 year, and 2 years

Long-term Follow-up

Extended monitoring of fusion rates and patient-reported outcomes

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Depo-Medrol

Trial Overview The study tests whether injecting Depo-Medrol into the psoas muscle after LLIF surgery reduces postoperative hip flexor weakness and thigh pain/numbness. It compares this treatment against Gel-Flow NT to see which is more effective in managing these symptoms.

How Is the Trial Designed?

Group I: Test group (standard care + study intervention) Experimental Treatment 2 Interventions

1 cc of gel foam powder mixed with thrombin and 80mg Depo-Medrol

Group II: Control group (standard care) Placebo Group 1 Intervention

1 cc gel foam powder mixed with thrombin

Who Is Running the Clinical Trial?

Hardeep Singh

Lead Sponsor

Trials

1

Recruited

80+

Society for Minimally Invasive Spine Surgery

Collaborator

Trials

2

Recruited

530+

Published Research Related to This Trial

In a study of 43 patients undergoing lumbar laminotomy, the use of methylprednisolone acetate (MP) significantly reduced hospital stay by 37% for primary procedures and 40% for repeat procedures, indicating improved recovery times.

Patients receiving MP also reported a substantial decrease in the need for pain medications: strong narcotics were reduced by 64% in primary cases and 70% in repeat cases, while milder pain medications and spasm medications were also significantly decreased, highlighting MP's efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefits of epidural methylprednisolone in a unilateral lumbar discectomy: a matched controlled study. Davis, R., Emmons, SE.[2013]

Two patients experienced vision loss in one eye after receiving a methylprednisolone acetate injection for chronic nasal inflammation, indicating a potential risk associated with this treatment.

The visual loss was linked to embolic occlusion of retinal and choroidal blood vessels, likely caused by microcrystal aggregates from the injected medication, highlighting a serious safety concern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. Whiteman, DW., Rosen, DA., Pinkerton, RM.[2022]

A case of conjunctival necrosis occurred in an 82-year-old patient after an inadvertent subconjunctival injection of methylprednisolone following cataract surgery, highlighting a serious complication associated with this medication.

Methylprednisolone is not approved for use in the eye, and this incident underscores the risks of using unapproved medications in ophthalmic procedures, emphasizing the need for caution and adherence to approved treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. van Zyl, LM., Hill, JJ.[2021]

In a study of 59 women undergoing abdominal hysterectomy, 125 mg of methylprednisolone did not reduce postoperative pain compared to placebo, particularly during mobilization, where pain scores were actually higher in the methylprednisolone group.

However, methylprednisolone was associated with significantly lower levels of C-reactive protein (CRP), indicating a potential anti-inflammatory effect, despite no differences in opioid use, antiemetic use, or recovery times between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a preoperative single-dose methylprednisolone on postoperative pain after abdominal hysterectomy: a randomized controlled trial. Aabakke, AJ., Holst, LB., Jørgensen, JC., et al.[2014]

In a study of 108 patients with acute lumbar disc prolapse and nerve-root pain, epidural and intrathecal corticosteroids (methylprednisolone acetate) showed a 75% response rate in those with symptoms lasting less than four weeks.

The effectiveness of the treatment decreased to 43% in patients with symptoms lasting more than six weeks, suggesting that early intervention is crucial for better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of lumbar nerve-root pain by intrathecal and epidural injections of depot methylprednisolone acetate. Ryan, MD., Taylor, TK.[2021]

In a study involving 1,043 patients undergoing cardiac surgery, administering 500 mg of methylprednisolone during surgery did not significantly reduce persistent incisional pain at 6 months compared to a placebo group.

Factors such as younger age, female sex, and surgical infections were identified as associated with a higher risk of developing persistent incisional pain, indicating that these may be important considerations in post-surgical pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Methylprednisolone Does Not Reduce Persistent Pain after Cardiac Surgery. Turan, A., Belley-Cote, EP., Vincent, J., et al.[2017]

Methylprednisolone acetate (Depo-Medrol) injections via epidural or intrathecal routes can effectively relieve diskogenic back pain and radiculopathy when conservative treatments have failed, particularly if symptoms have lasted less than three months.

Corticosteroid injections are less effective for patients with chronic symptoms lasting over three months or those who have previously undergone surgery, suggesting a limited window for optimal use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diskogenic pain using epidural and intrathecal steroids. Brown, FW.[2019]

Inadvertent injection of methylprednisolone acetate into the eye during vitrectomy can lead to severe retinal toxicity, resulting in significant vision loss and complications such as retinal necrosis and optic nerve damage.

This case highlights the critical need for careful identification of medications during eye surgeries to prevent serious adverse effects associated with incorrect injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. Yonekawa, Y., Sun, G., D'Amico, DJ., et al.[2014]

The study found that intraligamentary injection of slow-release methylprednisolone significantly reduced both the frequency and intensity of postoperative pain after root canal treatment compared to a placebo.

This suggests that slow-release methylprednisolone is an effective anti-inflammatory option for managing pain following dental procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraligamentary injection of slow-release methylprednisolone for the prevention of pain after endodontic treatment. Kaufman, E., Heling, I., Rotstein, I., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11660551/

a retrospective single-center study - PMC - PubMed Central Our results showed that postoperative intravenous methylprednisolone administration reduces postoperative pain: VAS pain scores and ODI ...

2. withpower.com withpower.com/trial/phase-4-muscle-weakness-4-2023-0671b

Depo-Medrol for Postoperative Pain In a study of 43 patients undergoing lumbar laminotomy, the use of methylprednisolone acetate (MP) significantly reduced hospital stay by 37% for primary ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2903111/

Local application of low-dose Depo-Medrol is effective in ... Results show that local application of low-dose Depo-Medrol is helpful in reducing immediate postoperative backache after discectomy, but it is not effective ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526590017306740

The Effect of Preoperative Intra-Articular ... Secondary outcomes included pain at 48 hours, during the first 14 days, sensitization (quantitative sensory testing with pressure pain threshold and wind-up ...

5. link.springer.com link.springer.com/article/10.1007/s44254-024-00069-z

Retrospective study of the efficacy of methylprednisolone ... This retrospective chart review showed that triamcinolone gave modestly better outcomes than methylprednisolone in some patient-reported pain ...

6. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-024-08145-y

Association between postoperative intravenous ... This study suggests that intravenous methylprednisolone administration may not increase the risk of SSI after single-level PLF.

7. rapm.bmj.com rapm.bmj.com/content/early/2025/02/26/rapm-2024-105656

Use and safety of corticosteroid injections in joints and ... Overall, IACS injections result in short-term pain relief from a few weeks to a few months. The adverse events include an increase in blood ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/011757s125lbl.pdf

DEPO-MEDROL® (methylprednisolone acetate injectable ... A marked increase in pain accompanied by local swelling, further restriction of joint motion, fever, and malaise are suggestive of septic arthritis. If this.