Depo-Medrol for Postoperative Pain

Overseen By Hardeep Singh, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Hardeep Singh

Must not be taking: Chronic oral steroids

Disqualifiers: Scoliosis, Spondylolisthesis, Diabetes, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing whether an injection of a steroid called Depo-medrol can help reduce hip and thigh pain after a specific type of back surgery. The goal is to see if this injection can make recovery easier for patients by reducing pain and weakness in the hip area. Depo-medrol, a corticosteroid, has been used in various medical contexts to reduce pain and inflammation, including postoperative settings.

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 data supports the effectiveness of the drug Depo-Medrol for postoperative pain?

Research shows that methylprednisolone acetate (Depo-Medrol) can significantly reduce postoperative pain and the need for pain medication after surgeries like lumbar discectomy and root canal treatment. It has been effective in decreasing pain intensity and the use of strong painkillers, leading to shorter hospital stays. ^{1 2 3 4 5}

Is Depo-Medrol generally safe for use in humans?

Depo-Medrol (methylprednisolone acetate) has been associated with serious complications when injected incorrectly, such as vision loss and tissue damage in the eye area. However, when used properly, it has been shown to reduce pain after certain medical procedures. ^{1 2 4 6 7}

How does the drug Depo-Medrol differ from other treatments for postoperative pain?

Depo-Medrol is unique because it is a slow-release corticosteroid (a type of anti-inflammatory drug) that can be injected to provide long-lasting pain relief, unlike other treatments that may require more frequent dosing. Its ability to reduce inflammation and pain over an extended period makes it different from standard pain medications that might not have the same prolonged effect. ^{1 2 4 8 9}

Research Team

Hardeep Singh, M.D.

Principal Investigator

UConn Health

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Depo-Medrol (Corticosteroid)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

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

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

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

Intraligamentary injection of slow-release methylprednisolone for the prevention of pain after endodontic treatment. [2019]

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

Benefits of epidural methylprednisolone in a unilateral lumbar discectomy: a matched controlled study. [2013]

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

Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]

5. Ireland pubmed.ncbi.nlm.nih.gov

The effect of a preoperative single-dose methylprednisolone on postoperative pain after abdominal hysterectomy: a randomized controlled trial. [2014]

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

Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. [2022]

7. India pubmed.ncbi.nlm.nih.gov

Conjunctival Necrosis due to Subconjunctival Methylprednisolone (Depo-Medrol™) Acetate Injection. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Management of lumbar nerve-root pain by intrathecal and epidural injections of depot methylprednisolone acetate. [2021]

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

Methylprednisolone Does Not Reduce Persistent Pain after Cardiac Surgery. [2017]